1,439 Results for

Regulatory Affairs Jobs in Kenmore, MA

Jobs

Associate Director, Global Regulatory Affairs CMC Takeda Pharmaceutical

Boston, MA

Proactively communicates CMC regulatory strategies, key issues and risks through assigned programs / products development activities and LCM in adequate and timely manner to cross-functional programs/ products teams and management level within GRA CMC, GRA, PS, GMS and QA - as appropriate. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows: With minimal supervision, develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products.

5 days ago

Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product Takeda Pharmaceutical

Boston, MA

As Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product, you will provide strategic leadership and development to global regulatory subject matter experts to ensure innovative and robust regulatory strategies for medical devices and drug-device combination products, maximizing global regulatory success and minimizing time to approval/clearance. Leads and develops a team of regulatory leaders and subject matter experts, overseeing global regulatory strategy and major submissions for an assigned portfolio of medical devices and drug-device combination products, ensuring clear strategy, high-quality execution, and timely approvals/clearances.

5 days ago

Senior Manager, Global Regulatory Affairs CMC Takeda Pharmaceutical

Boston, MA

This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows: This role is within in the GRA Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows: With some supervision, leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.

5 days ago

Executive Director, Global Regulatory Affairs CMC Early Development Takeda Pharmaceutical

Boston, MA

Accountable for ensuring global CMC content quality and compliance for early development submissions and lifecycle changes through Phase 2 (e.g., IND/CTA modules, IMPD quality sections, amendments, investigator’s brochure CMC, and responses to health authority questions), partnering with regional leads and technical functions to ensure consistent, inspection-ready documentation. Represents Global Regulatory Affairs CMC in senior-level governance and in interactions with global health authorities, including FDA, EMA, MHRA, PMDA, and other agencies as applicable, to enable efficient pathways for early development CMC strategies and submissions (e.g., pre-IND/IND/CTA, amendments, Type B/C meetings, scientific advice).

5 days ago

Sr. Medical Affairs Specialist Atrium

Boston, MA

$75–$85 / hour

Medical Affairs Specialist will play a key role in interpreting clinical evidence, responding to complex medical inquiries, and supporting evidence generation strategies that inform product development and healthcare decision-making. Medical Affairs Specialist will leverage clinical expertise and scientific knowledge to support medical communications, evidence dissemination, and cross-functional initiatives that communicate the clinical value of innovative medical technologies.

2 days ago

Senior Manager, Regulatory Lead Takeda Pharmaceutical

Boston, MA

Assists in the creation and submission of high quality, compliant regulatory documents (e.g., BLAs, INDs, CTAs, MAAs, Variations/Supplements and other relevant regulatory filings such as PIPs/PSPs, ODDs, meeting requests and briefing packages) for assigned programs within defined timelines as per R&D and business objectives. See Takeda Pharmaceutical Terms of Use at https://www.takeda.com/terms-of-use/ and Privacy Policy at https://www.takeda.com/privacy-notice/ and SonicJobs Privacy Policy at https://www.sonicjobs.com/us/privacy-policy and Terms of Use at https://www.sonicjobs.com/us/terms-conditions.

5 days ago

Document Control/Regulatory Compliance Coordinator - M PLS Staffing Solutions, Inc

Beverly, MA

$60,000–$65,000 / year
Full time

Responsible for creation, organization, control, and maintenance of various core processes documentation (Engineering, Quality, and other Operations) in accordance with the company Quality Management System (QMS) procedures and policies. Regulatory Compliance will support the organization's Regulatory Affairs and Quality Assurance functions in multiple areas including documentation, compliance, audits and regulatory submissions.

24 days ago

Director, Global Regulatory Labeling Strategy Takeda Pharmaceutical

Boston, MA

Remote

Conducts precedent searches, analyzes relevant competitor labeling, health authority labeling requests for Takeda products, labeling guidance and trends; and develops strategies and labeling language for inclusion assigned product labels (TLP, CCDS, USPI, EU SmPC, others as appropriate) to ensure consistency with the overall product strategy, product claims and information in the CCDS and to ensure that Takeda products have the most competitive labeling possible; while maintaining awareness of recent in-class approvals. In alignment with TAU/MPD Labeling Lead, coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee - GLOC) providing leadership to foster cross-functional collaboration and drive alignment of the labeling strategy and labeling content at all levels.

5 days ago

Associate Director, Global Labeling Lead Takeda Pharmaceutical

Cambridge, MA

The Global Regulatory Labeling Strategy Lead (Associate Director), Plasma-Derived Therapies Business Unit (PDT BU) is a key role in Global Labeling and works under the direction of the Head of Global Labeling and is: Responsible, with minimal supervision for providing regulatory expertise, strategic insight, and guidance to internal stakeholders, including Clinical, Pharmacovigilance, Legal, Scientific, Commercial, to ensure successful development and maintenance of labeling managed within PDT BU’s Global Labeling function, pertaining to pharmaceutical drug and device. In close collaboration with the Takeda R&D labeling function, oversees the direction, management and implementation of the labeling processes, templates, tools and systems to improve efficiency, productivity and quality and consistency across products and compliance with regulatory labeling guidance.

5 days ago

Associate Director, Clinical Assay Strategy, Flu CSL Seqirus

Waltham, MA

$179,000–$212,000

This role is intended for a recognized subject matter expert who understands the scientific, operational, and regulatory evolution of influenza immunogenicity assessment, including HAI, microneutralization (MN), ELLA, and multiplex platforms, and can strategically navigate assay modernization while maintaining regulatory alignment. Headquartered in Melbourne, Australia, with major manufacturing hubs in Holly Springs, NC, and Liverpool, UK, the company operates the world’s largest cell-based vaccine facility and serves as a primary partner to governments for global pandemic preparedness.

1 day ago

Sr. Network Architect ECLARO

Boston, MA

Strong hands-on knowledge of LAN/WAN protocols and technologies including Carrier Ethernet, T1, DS3, optical, DWDM, NTP, Spanning Tree, VLAN's, 802.1q, VFR, LFA, SMTP, SNMP v1-v3, OSPF, BGP, MPLS, VPLS, Ethernet, TCP/IP, SSL, SSH, SIP, H.323, QoS, Multicast, Anycast, 802.1x, Radius, NAC, DHCP, DNS, F5 Wide-IP, VRRP, HSRP, GLBP, PBR, VPC, LACP, SGT, SGACL, SXP, VxLAN, OTP, LISP, SPAN, WCCP, PfR, IPSLA, iWAN, VPN, IPSec, Wi-Fi 6, 6E, 7. Proven experience and success with planning, installing and managing networks including LAN, MAN, WAN, Optical Networking, DWDM, Wi-Fi, Silverpeak SDWAN or Riverbed WAN Optimizers, F5 Load Balancers, F5 GTM Global Traffic Manager, Cisco Catalyst Center, and security (firewalls, VPN, DMZ, IDS/IPS, WebProxy, content filter, FireEye, NAC and Cisco TrustSec) infrastructure.

10 days ago

Senior Director, Immunology and Translation CSL Behring

Waltham, MA

$302,000–$350,000

You will bring end-to-end experience from early ideation through first-in-disease and will partner closely with cross-functional teams including discovery research, translational medicine, clinical development, and business development to shape and advance CSL Behring's immunology pipeline. Represent CSL Behring at key scientific conferences, advisory boards, and KOL meetings; build and leverage a broad external network of thought leaders, clinical investigators, and academic collaborators.

1 day ago

Senior Director Regulatory Affairs Liaison- General Medicine Merck & Co Inc

Boston, MA

$190,800–$300,300 / year

Required Skills: Corporate Commercial, Cross-Cultural Awareness, Drug Development, Exercises Judgment, Global Health, Global Market, Healthcare Innovation, Interpersonal Relationships, In Vitro Diagnostics (IVD), Multiple Therapeutic Areas, Oral Communications, Orphan Drugs, Pharmaceutical Regulatory Affairs, Process Improvements, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Issues, Regulatory Management, Regulatory Strategy Development, Written Communication. As the Global Regulatory Lead (GRL), the Senior Principal Scientist functions as the regulatory single, accountable, global point of contact on the project team and interacts with the global regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more company investigational and marketed drugs/biologics in early- and/or late-stage development.

30+ days ago

Staff Regulatory Affairs Associate (Digital Health & AI Technologies) Whoop

Boston, MA

$170,000–$220,000 / year

At WHOOP, we view total compensation as the combination of base salary, equity, and benefits, with equity serving as a key differentiator that aligns our employees with the long-term success of the company and allows every member of our corporate team to own part of WHOOP and share in the company's long-term growth and success. Partner with Product, Engineering, and AI/ML teams to evaluate regulatory implications of new features, algorithms, health insights, claims, intended uses, and user experiences, and recommend appropriate regulatory and claims strategies.

5 days ago

Regulatory Affairs Associate Integrated Resources, Inc

Cambridge, Massachusetts

Contractor

Associate II level)· Responsible for submission activity on several programs· Report to head of submissions group, work with Regulatory Development managers on each program· Responsibilities include:Act as liaison to CROWork with CRO to file initial CTAs (clinical trial applications) and amendmentsTracking of CTA filings and approvalsCoordinate Query ManagementAttend SMT meetings for relevant clinical studiesLiaise with CMC regulatory on CMC CTA filings/amendmentsQUALIFICATIONS:· Ideally 1-2 years' experience in Regulatory Affairs.· Regulatory Affairs AssociateIntegrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms.

8 days ago

Principal Regulatory Affairs Specialist Cardinal Health Inc

Mansfield, MA

Remote

$80,900–$127,050 / year

This includes being a regulatory lead for change development projects, new product development, change assessment, US, EU and international regulatory submissions, commercial support, manufacturing support, compliance related activities, systems improvement, and other responsibilities aligned with global medical device regulations and the goals of the Medical Solutions business. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity.

11 days ago

Associate Director Regulatory Affairs Viridian Therapeutics Inc

Waltham, MA

Reporting to the Senior Director, Regulatory Affairs, the Associate Director, Regulatory Affairs will represent Regulatory Affairs on assigned cross-functional teams and lead day-to-day regulatory activities for product development and approval in alignment with the corporate strategy for Viridian's Thyroid Eye Disease (TED) and TSHR portfolio. Communicate with internal and external stakeholders, including members of the leadership teams, to ensure cross-functional alignment, work with Regulatory CMC and Regulatory Operations teams to establish and meet timelines for regulatory submissions.

30+ days ago

Associate Director Regulatory Affairs, Oncology GSK plc

Waltham, MA

$138,750–$231,250 / year

This role will ensure the development of appropriate global and/or regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy /Integrated Asset plan to ensure the development program meets the needs of the key markets identified and the Medicines Profile. Work with the Early/Medicine Development Team (EDT/MDT) or GRL, to ensure a robust regulatory strategy is in place to support the development program to meet the needs of the key markets identified in the Integrated Asset plan and the Medicine Profile.

30+ days ago

Senior Director, Regulatory Affairs Strategy - Cell and Gene Therapy AstraZeneca Plc

Boston, MA

$218,058–$327,087 / year

Accountabilities: Global Regulatory Leadership: Own the end-to-end global regulatory strategy for a high-complexity cell and gene therapy program, from current stage through BLA submission, ensuring an efficient route to approval with competitive labeling aligned to product attributes and patient, market and business needs. Cross-Functional Product Leadership: Represent Regulatory Affairs on Global Product Teams, shaping development and commercialization plans, contributing to governance presentations and aligning regulatory objectives with clinical, CMC, safety and commercial strategies.

30+ days ago

Sr. Manager/Associate Director, Regulatory Affairs Oruka Therapeutics

Waltham, California

$161,000–$187,000 / year

Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. This individual will work closely with cross-functional teams to provide regulatory guidance throughout product development, support health authority interactions, and help ensure the timely preparation and submission of high-quality regulatory applications.

30+ days ago

Director, Global Regulatory Affairs Lead (Oncology) GSK plc

Waltham, MA

$171,750–$286,250 / year

Proven track record of facilitating groups of individuals to work together on creating solutions and developing regulatory strategies, proactively seeking information and insight from a broad range of sources and weight benefits and risks before making important decisions. Works with the respective GRS TG Portfolio Lead and TG VP to ensure a robust regulatory strategy and appropriate TG resource is in place to support respective development programs to meet the needs of the key markets identified in the IES and the Medicine Profile.

8 days ago

Associate Director Regulatory Affairs Alnylam Pharmaceuticals Inc

Cambridge, MA

$170,900–$231,300 / year

Additional responsibilities include involvement in the writing and oversight of regulatory submissions, coordinating all aspects of paper and electronic regulatory submissions, proactively keeping updated on US regulatory requirements, and interpreting regulatory intelligence for the internal teams. Serve as member of/or lead the Global Regulatory Team, may serve as Regulatory representative in multidisciplinary product subteams or core team for assigned programs and participate as an active team member.

30+ days ago

Senior International Regulatory Affairs Specialist Butterfly Network

Burlington, MA

In addition to its medical imaging products, Butterfly Embedded is the Company's Ultrasound-on-Chip licensing and co-development program designed to enable a new wave of ultrasound-enabled technologies across non-competitive healthcare markets and beyond. Utilize and maintain regulatory systems and tools (e.g., document management systems, regulatory submission platforms, and tracking tools) to support ongoing regulatory activities, submissions, and communications with regulatory bodies.

30+ days ago

CMC Regulatory Affairs Manager Integrated Resources, Inc

Waltham, Massachusetts

Contractor

Assess impact on specific projects Assess compliance of CMC document with the current Guidelines and Regulations Assess regulatory impact of proposed CMC changes to licenses or clinical trial applicationsQualifications• BA/BS/University degree required, Life/Health Sciences preferred. A minimum of 7 years in the Pharmaceutical Industry, and a minimum 5 years regulatory CMC experience (Biologics) Demonstrate strong organizational skills, including the ability to prioritize personal and direct reports workload.

8 days ago

Director, Regulatory Affairs Liaison, Vaccines & Infectious Diseases Merck & Co Inc

Boston, MA

$210,400–$331,100 / year

Required Skills: Biological Sciences, Biostatistics, Clinical Judgment, Clinical Trial Planning, Clinical Trials, Communication, Cross-Functional Collaboration, Detail-Oriented, Infectious Disease, Leadership, Medical Writing, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Intelligence, Regulatory Issues, Regulatory Strategy Development, Regulatory Writing. Primary activities include, but are not limited to: Functions with a high degree of independence and provides regulatory oversight for assigned products, functioning as the single, accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.

30+ days ago

Executive Advisor, Enterprise Risk and Regulatory Affairs University of Massachusetts Medical School

Westborough, Massachusetts

The incumbent will work closely with For Health Consulting Deputy Executive Vice Chancellor, Associate Executive Vice Chancellors (AEVCs) and Managing Directors (MDs) to anticipate and address potential legal risks related to new and existing For Health business initiatives and internal processes; serve as a creative problem solver for complex business, legal, and compliance challenges to facilitate the development of business strategy and subsequent growth in products and services; and lead negotiations on behalf of ForHealth Consulting where appropriate. In this leadership position, the candidate must demonstrate influencing skills and organizational savvy to effectively interact with multiple internal business unit leaders at ForHealth Consulting, key stakeholders throughout the broader UMass Chan Medical School and University of Massachusetts system, and many other external partners in public and private organizations.

18 days ago

Associate Director, Regulatory Affairs CMC Skyhawk Therapeutics Inc

Waltham, MA

$170,000–$230,000 / year

Working closely with the Director, RegCMC, you will help serve as a RegCMC point of contact across the organization, partnering with Pharmaceutical Development, Manufacturing, Quality, and Program teams to deliver high-quality, timely regulatory submissions that advance clinical development and support eventual commercialization. We use our novel SkySTAR platform (Skyhawk Small molecule Therapeutics for Alternative splicing of RNA) to develop drug candidates directed toward targets for some of the world's most intractable diseases including neurological conditions, cancer, and traditionally "undruggable" targets.

23 days ago

Associate Director, Regulatory Affairs Entrada Therapeutics Inc.

Boston, MA

Remote

$171,000–$204,000 / year

We are a tight-knit team of experts and leaders in both therapeutic development and rare diseases and are excited to grow and attract colleagues who are ready to join a high-energy, dedicated team that likes to get things done and dramatically improve the lives of patients and their families. We expect multiple clinical data readouts as we advance several DMD programs across the U.K., EU, and U.S. By year-end 2026, we anticipate four clinical-stage programs in our DMD franchise (ENTR-601-44, ENTR-601-45, ENTR-601-50, and ENTR-601-51).

30+ days ago

Senior International Regulatory Affairs Specialist Butterfly Network Inc

Burlington, MA

This role requires a strong ability to translate evolving regulatory requirements-such as EU MDR 2017/745-into clear, actionable plans, while partnering cross-functionally to align regulatory expectations with fast-paced product and software development cycles. In addition to its medical imaging products, Butterfly Embedded is the Company's Ultrasound-on-Chip licensing and co-development program designed to enable a new wave of ultrasound-enabled technologies across non-competitive healthcare markets and beyond.

30+ days ago

Associate Director, Regulatory Affairs CMC CRISPR Therapeutics

South Boston, Massachusetts

$165,000–$180,000 / year

The Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY® (exagamglogene autotemcel [exa-cel]), the world’s first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia. You will work in close collaboration with CMC and global development teams, and with relevant external parties including contract manufacturing organizations, expert consultants, development partners, and global health authorities.

13 days ago

VP or SVP, Regulatory Affairs Acrivon Therapeutics Inc

Watertown, MA

These distinctive capabilities enable the company to go beyond the limitations of traditional drug discovery, as well as current AI-based target-centric drug discovery and rapidly design highly differentiated compounds with desirable pathway effects through intracellular protein network analyses and advance these agents into the clinic for streamlined development. Acrivon is currently advancing its lead program, ACR-368 (also known as prexasertib), a selective small molecule inhibitor targeting CHK1 and CHK2 in a potentially registrational Phase 2 trial for endometrial cancer.

30+ days ago

VP Or Svp, Regulatory Affairs Acrivon Therapeutics Inc.

Watertown, MA

30+ days ago

Associate Director, Regulatory Affairs CMC CRISPR Therapeutics AG

South Boston, MA

$165,000–$180,000 / year

The Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY (exagamglogene autotemcel [exa-cel]), the world's first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia. You will work in close collaboration with CMC and global development teams, and with relevant external parties including contract manufacturing organizations, expert consultants, development partners, and global health authorities.

30+ days ago

Associate Director Regulatory Affairs CMC Alnylam Pharmaceuticals Inc

$170,900–$231,300 / year

Lead or help to lead the interpretation of regulatory expectations for emerging modalities, including oligonucleotide therapeutics, conjugated delivery systems (e.g., GalNAc and other targeting ligands), antibody-drug conjugates, peptide conjugates, and biologic or hybrid modalities. This role serves as a key bridge between Research, Pharmaceutical Development, Technical Operations, and Regulatory Sciences, helping to translate evolving science into effective global regulatory CMC strategies.

30+ days ago

Director, Regulatory Affairs – Global Regulatory Strategy Monte Rosa Therapeutics, Inc

Boston, Massachusetts

Full time

Overview: Monte Rosa Therapeutics is seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our development programs, with a focus on immunology. Lead the preparation, submission, and maintenance of regulatory applications, including INDs, CTAs, marketing applications, Annual Reports, Orphan Drug Designation, Requests for Fast Track, and other regulatory documents.

30+ days ago

Sr. Manager/Associate Director, Regulatory Affairs Oruka Therapeutics Inc

Waltham, MA

$161,000–$187,000 / year

Oruka's mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. This individual will work closely with cross-functional teams to provide regulatory guidance throughout product development, support health authority interactions, and help ensure the timely preparation and submission of high-quality regulatory applications.

30+ days ago

Contract Specialist, Regulatory Affairs (Tewksbury, MA, US, 01876) Corning Inc

Tewksbury, MA

$71,252–$97,972 / year

Our health and well-being benefits include medical, dental, vision, paid parental leave, family building support, fitness, company-paid life insurance, disability, disease management programs, paid time off, and an Employee Assistance Program (EAP) to support you and your family. Today, we accelerate and transform life sciences, mobile consumer electronics, optical communications, display, automotive, and solar markets.

4 days ago

Senior Regulatory Affairs Specialist Boston Scientific Corp

Marlborough, MA

At Boston Scientific, our Urology business provides proven, leading solutions to treat several common urology diseases, including kidney stones, benign prostatic hyperplasia (BPH), erectile dysfunction (ED), overactive bladder, urinary and fecal incontinence, and pelvic floor disorders. Act as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy, regulatory pathway development, testing requirements, clarification and follow-up of submissions under review.

11 days ago

Vice President, Regulatory Affairs Rhythm Pharmaceuticals Inc

Boston, MA

$260,000–$360,000 / year

This leader will oversee a geographically diverse team responsible for execution of international regulatory affairs, regulatory operations, regulatory business operations, labeling, and CMC regulatory, while partnering closely with global regulatory strategy and cross-functional teams. Proven operational leadership with urgency and discipline, including experience leading high-performing teams, team leaders, and subject matter experts through growth, change, and increasing organizational complexity.

30+ days ago

Associate Director, Global Regulatory Affairs Kailera Therapeutics

Waltham, Massachusetts

$155,000–$190,000 / year

The Associate Director, Global Regulatory Affairs will be responsible for day-to-day regulatory activities of early/late phase investigational products, leading the writing and submission of IND/CTA/amendments and future marketing application submissions, providing guidance to the team on regulatory filings and responses, and providing critical regulatory intelligence and guidance back to the team. The Associate Director will work on cross-functional teams, partnering with key internal/external team members including Regulatory CMC and Regulatory Operations to ensure the scientific data and submissions fulfills agency expectations in a compliant manner.

1 day ago

Regulatory Affairs Specialist Careerscape

Boston, MA

$90,000–$125,000 / year
Full time

Our client, a clinical-stage biotechnology company based in Boston's Seaport District, is looking for a Regulatory Affairs Specialist to join their growing regulatory team. The position reports directly to the VP of Regulatory Affairs and works closely with cross-functional teams including R&D, clinical operations, and quality assurance.

30+ days ago

Senior Manager, Regulatory Affairs Getinge Group

Boston, MA

Remote

The Senior Manager, Regulatory Affairs, provides regulatory strategy and execution leadership for U.S., EU, and Rest of World (ROW) market access and compliance to enable safe, compliant market access for a broad Surgical Workflows Infection Control Consumable (SWICC) products portfolio, including a wide range of infection control consumables, while also supporting capital equipment such as sterilizers, washer-disinfectors, ultrasonic equipment, surgical lights, and operating tables. Serve as Regulatory Affairs authority in cross-functional product development teams, ensuring regulatory requirements are embedded in design controls, technical documentation, risk management (ISO 14971), labeling, and verification/validation planning, with accountability for U.S. (FDA), EU MDR, and applicable ROW regulatory decision-making.

30+ days ago

Executive Advisor, Enterprise Risk and Regulatory Affairs UMass Chan Medical School

Westborough, MA

The incumbent will work closely with ForHealth Consulting Deputy Executive Vice Chancellor, Associate Executive Vice Chancellors (AEVCs) and Managing Directors (MDs) to anticipate and address potential legal risks related to new and existing ForHealth business initiatives and internal processes; serve as a creative problem solver for complex business, legal, and compliance challenges to facilitate the development of business strategy and subsequent growth in products and services; and lead negotiations on behalf of ForHealth Consulting where appropriate. In this leadership position, the candidate must demonstrate influencing skills and organizational savvy to effectively interact with multiple internal business unit leaders at ForHealth Consulting, key stakeholders throughout the broader UMass Chan Medical School and University of Massachusetts system, and many other external partners in public and private organizations.

24 days ago

Global Regulatory Affairs (CMC) Manager Integrated Resources, Inc

Lexington, Massachusetts

Contractor

Job DescriptionClient: Direct ClientLocation: Lexington, MAJob Title: Global Regulatory Affairs (CMC) ManagerDuration: 5 Months + (Possible Extension)Summary: Under the direction of the Director of Regulatory Affairs direct and manage Regulatory Affairs activities for developing global CMC strategies across product life cycles & execution in North America. Job Function and Description:• Provide regulatory support, guidance and expertise to internal groups such as product development, QA, QC and manufacturing teams to ensure that all applicable regulatory requirements are considered and appropriately incorporated into development programs and that products are developed and manufactured in compliance with appropriate regulations and guidelines so that they be studied and marketed as planned.•

8 days ago

Senior Director, Regulatory Affairs (Ad Promo) Bausch Health Companies Inc

Boston, MA

$215,000–$296,000 / year

Represents regulatory affairs in cross functional prescription product promotional review teams as required, participate in development committees for processes and procedures relating to ad promo. Job Location: Washington, District of Columbia, USA | Boston, Massachusetts, USA | Bridgewater, New Jersey, USA | NewYorkCity, New York, USA | Philadelphia, Pennsylvania, USA.

22 days ago

Regulatory Affairs Manager Dentsply Sirona

Boston, MA

This role works closely with business partners for registrations in their respective countries to ensure compliance globally and acts as an internal champion for initiatives aimed at improving business systems and compliance. • Manages day-to-day activities for less senior Regulatory Affairs professionals, including but not limited to mentoring, coaching, performance reviews, developmental plans, and succession planning.

29 days ago

Associate Director, Regulatory Affairs CMC Skyhawk Therapeutics

Waltham, Massachusetts

Working closely with the Director, RegCMC, you will help serve as a RegCMC point of contact across the organization, partnering with Pharmaceutical Development, Manufacturing, Quality, and Program teams to deliver high-quality, timely regulatory submissions that advance clinical development and support eventual commercialization. We use our novel SkySTAR® platform (Skyhawk Small molecule Therapeutics for Alternative splicing of RNA) to develop drug candidates directed toward targets for some of the world’s most intractable diseases including neurological conditions, cancer, and traditionally “undruggable” targets.

23 days ago

Associate Director, Regulatory Affairs Entrada Therapeutics Inc

Boston, MA

Remote

$171,000–$204,000 / year

30+ days ago

Associate Director, Regulatory Affairs Operations Third Rock Ventures

Cambridge, MA

$200,000–$240,000 / year

This role will focus on regulatory submission planning, execution, and lifecycle management, working closely with Regulatory Affairs leadership and cross-functional teams to ensure high-quality, timely regulatory submissions. We specifically target pathogenic antibodies and their cellular sources with bespoke Fc biotherapeutics engineered to selectively and completely eliminate the root causes of autoimmune and allergic diseases, and to achieve deep, durable responses while preserving essential immunity.

30+ days ago

Director, Quality Assurance and Regulatory Affairs Meridian Bioscience Inc

Ensure proper and timely preparation and maintenance of national and international new product submissions, registration/licensing renewals, product listings, post market surveillance reports, import and export documents, safety testing, and other national and international requirements. At least 10 years' experience leading in the medical devices industry; experience regarding medical device design, development and manufacturing regulations, specifically21 CFR Part 820 Quality System Regulation, the IVD Directive 98/79 EC, as well as ISO 13485 requirements.

30+ days ago

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Regulatory Affairs Jobs in Kenmore, MA

Associate Director, Global Regulatory Affairs CMC Takeda Pharmaceutical

Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product Takeda Pharmaceutical

Senior Manager, Global Regulatory Affairs CMC Takeda Pharmaceutical

Executive Director, Global Regulatory Affairs CMC Early Development Takeda Pharmaceutical

Sr. Medical Affairs Specialist Atrium

Senior Manager, Regulatory Lead Takeda Pharmaceutical

Document Control/Regulatory Compliance Coordinator - M PLS Staffing Solutions, Inc

Director, Global Regulatory Labeling Strategy Takeda Pharmaceutical

Associate Director, Global Labeling Lead Takeda Pharmaceutical

Associate Director, Clinical Assay Strategy, Flu CSL Seqirus

Sr. Network Architect ECLARO

Senior Director, Immunology and Translation CSL Behring

Senior Director Regulatory Affairs Liaison- General Medicine Merck & Co Inc

Staff Regulatory Affairs Associate (Digital Health & AI Technologies) Whoop

Regulatory Affairs Associate Integrated Resources, Inc

Principal Regulatory Affairs Specialist Cardinal Health Inc

Associate Director Regulatory Affairs Viridian Therapeutics Inc

Associate Director Regulatory Affairs, Oncology GSK plc

Senior Director, Regulatory Affairs Strategy - Cell and Gene Therapy AstraZeneca Plc

Sr. Manager/Associate Director, Regulatory Affairs Oruka Therapeutics

Director, Global Regulatory Affairs Lead (Oncology) GSK plc

Associate Director Regulatory Affairs Alnylam Pharmaceuticals Inc

Senior International Regulatory Affairs Specialist Butterfly Network

CMC Regulatory Affairs Manager Integrated Resources, Inc

Director, Regulatory Affairs Liaison, Vaccines & Infectious Diseases Merck & Co Inc

Executive Advisor, Enterprise Risk and Regulatory Affairs University of Massachusetts Medical School

Associate Director, Regulatory Affairs CMC Skyhawk Therapeutics Inc

Associate Director, Regulatory Affairs Entrada Therapeutics Inc.

Senior International Regulatory Affairs Specialist Butterfly Network Inc

Associate Director, Regulatory Affairs CMC CRISPR Therapeutics

VP or SVP, Regulatory Affairs Acrivon Therapeutics Inc

VP Or Svp, Regulatory Affairs Acrivon Therapeutics Inc.

Associate Director, Regulatory Affairs CMC CRISPR Therapeutics AG

Associate Director Regulatory Affairs CMC Alnylam Pharmaceuticals Inc

Director, Regulatory Affairs – Global Regulatory Strategy Monte Rosa Therapeutics, Inc

Sr. Manager/Associate Director, Regulatory Affairs Oruka Therapeutics Inc

Contract Specialist, Regulatory Affairs (Tewksbury, MA, US, 01876) Corning Inc

Senior Regulatory Affairs Specialist Boston Scientific Corp

Vice President, Regulatory Affairs Rhythm Pharmaceuticals Inc

Associate Director, Global Regulatory Affairs Kailera Therapeutics

Regulatory Affairs Specialist Careerscape

Senior Manager, Regulatory Affairs Getinge Group

Executive Advisor, Enterprise Risk and Regulatory Affairs UMass Chan Medical School

Global Regulatory Affairs (CMC) Manager Integrated Resources, Inc

Senior Director, Regulatory Affairs (Ad Promo) Bausch Health Companies Inc

Regulatory Affairs Manager Dentsply Sirona

Associate Director, Regulatory Affairs CMC Skyhawk Therapeutics

Associate Director, Regulatory Affairs Entrada Therapeutics Inc

Associate Director, Regulatory Affairs Operations Third Rock Ventures

Director, Quality Assurance and Regulatory Affairs Meridian Bioscience Inc

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