1,170 Results for

Regulatory Affairs Jobs in Brookline, MA

Jobs

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.

7 days 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.

7 days 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 Inc

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.

30+ days ago

Regulatory Affairs Associate:$71,449+ YR Ajinomoto Cambrooke, Inc.

Ayer, MA

Ability to sit for extended periods, perform visual inspections of labels/documents, occasional lifting up to 25 lbs., standing/walking/bending as needed. Perform regulatory research, document reviews, label proofreading, version control, and cross-functional coordination to enable compliant product release.

20 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

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.

27 days ago

Executive Director, Regulatory Affairs Merck & Co Inc

$255,800–$402,700 / year

10% Travel Required Skills: Antibody Drug Conjugates (ADC), Antibody Drug Conjugates (ADC), Biopharmaceuticals, Biopharmaceutics, Chemistry, Collaborative Development, Confidentiality, Cross-Cultural Awareness, Decision Making, Electronic Common Technical Document (eCTD), Executive Management, Mentoring Staff, People Leadership, Pharmaceutical Sciences, Professional Networking, Project Management, Regulatory Affairs Management, Regulatory CMC, Regulatory Compliance Audits, Regulatory Development, Regulatory Monitoring, Regulatory Reporting, Regulatory Risk, Regulatory Submissions, Risk Analysis {+ 2 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Accountable for ensuring successful development and implementation of the global CMC regulatory strategy and for global registration and post approval strategy for new products to meet our company's business needs Leads the team responsible regulatory CMC deliverables including submissions supporting clinical studies through initial market applications and post-approval to ensure global commercial supply.

30+ 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.

22 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.

16 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

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

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.

6 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

Sr. Manager/Associate Director, Regulatory Affairs Oruka Therapeutics

Waltham, California

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

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 CRISPR Therapeutics

South Boston, Massachusetts

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

Associate Director, Regulatory Affairs CMC Voyager Therapeutics

Cambridge, Massachusetts

The Associate Director of Regulatory Affairs CMC will be responsible for developing, implementing and advising on global Regulatory CMC strategies for new and late stage programs to secure approval of the manufacturing process and control testing for initial clinical trials under INDs/CTAs and transition to appropriate GMP validation to move expeditiously in Phase 3 trials with material suitable for commercialization to support market access for Voyager’s gene therapy products. The qualified candidate will define Regulatory CMC submission strategies and plan, construct, direct, write summaries/reports for CMC sections of INDs, CTAs, BLAs and MAAs including post-approval supplemental applications and coordinate responses during the review/approval by Regulatory authorities.

15 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

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.

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.

26 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, Regulatory Affairs, Advertising, Promotion & Labeling (RA-APL) Intellia Therapeutics Inc

Cambridge, MA

Remote

$193,176–$236,104 / year

This role works closely with commercial/launch teams, medical affairs, research and development, corporate communications, and legal to ensure external communications, including but not limited to promotional communications, are compliant with regulatory requirements and align with strategic objectives and commercial regulatory strategy. Represents Regulatory on the Commercial Medical, Legal, Regulatory Committee (CMLR) to navigate claims and presentations, providing advice based on the Federal Food, Drug, & Cosmetic Act (FDCA) and implementing regulations impacting advertising & promotional labeling.

30+ 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.

6 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.

12 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.

3 days ago

Associate Director, Global Regulatory Affairs - GI & Inflammation Takeda

Boston, Massachusetts

Demonstrates strong skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.

30+ 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

Regulatory Affairs & Compliance Lead Carrier Corporation

Beverly, MA

$96,000–$192,000 / year

In this strategic individual contributor role, the Regulatory Affairs & Compliance Lead collaborates cross-functionally with Product Development, Quality, Manufacturing, Marketing, Legal, and Compliance teams to ensure regulatory alignment and market readiness. The Regulatory Affairs & Compliance Lead leads the development and execution of global regulatory strategies, manage submissions and regulatory changes, and support product launches across international markets.

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

Regulatory Affairs Strategy Director AstraZeneca Plc

Boston, MA

$186,232.80–$279,349.20 / year

Competitive salary and benefits package on offer: Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. The more experienced you are, the more accountability you will have for strategic leadership including responsibility for development and implementation of the global regulatory strategy for a product/group of products of increasing complexity.

26 days ago

Associate Director, Regulatory Affairs Entrada Therapeutics

Boston, Massachusetts

Remote

30+ days ago

Senior Regulatory Affairs Specialist Smith & Nephew Plc

Mansfield, MA

$101,500–$152,250 / year

The anticipated base compensation range for this position is $101,500.00 - $152,250.00 USD annually and the compensation offered will depend on the candidate's qualifications, job-related knowledge/skills, geographical location. Inclusion and Belonging- Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about Employee Inclusion Groups on our website ( https://www.smith-nephew.com/

30+ days ago

Associate Director, Global Regulatory Affairs CMC Takeda Pharmaceutical Co Ltd

Boston, MA

$153,600–$241,340 / year

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 teams 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.

30+ days ago

Chief of Staff, Senior Director Global Regulatory Affairs AstraZeneca Plc

Boston, MA

$218,058.40–$327,087 / year

Organizational Effectiveness and Change: Support organization design, capability building, and talent initiatives; lead change programs and improvements in ways of working that increase clarity, speed, and accountability across the regulatory organization. Cross-Functional and Enterprise Coordination: Partner across R&D, Commercial, Safety, Medical, Legal, Finance, and Procurement to align competing priorities; coordinate across programs, therapy areas, and regions to resolve complex issues that impact filing readiness and approvals.

5 days ago

Associate Director, Global Regulatory Affairs Marketed Products Takeda Pharmaceutical Co Ltd

Boston, MA

$153,600–$241,340 / year

Accountable for execution of global regulatory strategy including the provision of global regulatory submissions to local Takeda affiliates in compliance with local regulatory working with regional leads, other functions and vendors. Leads the Global Regulatory Team (GRT) and applicable sub-working groups, such as the Label Working Group, and represents GRT at project team meetings as global and/or regional regulatory lead.

30+ days ago

Director, Business Development Regulatory Affairs Olympus Corp

Westborough, MA

Take responsibility for all RA aspects of each business development project by a) conducting or overseeing due diligence and integration activities, b) building a functional plan for each project to ensure that functional risks are identified, and actions are planned, and c) securing necessary approvals from RA/regional leadership for due diligence reports and integration strategy/plans. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America.

7 days ago

Manager, Regulatory Affairs Monte Rosa Therapeutics, Inc

Boston, Massachusetts

Full time

Researches and analyzes regulatory information and determines acceptability of data, procedures, and other product-related documentation presented in support of product registration. Under supervision, compiles regulatory submissions, license renewal and annual registrations to the US Food and Drug Administration (FDA) and other regulatory agencies.

30+ days ago

Associate Director, Global Regulatory Affairs, Precision Medicine & Digital Health Takeda

Massachusetts

Remote

Partner with local/regional regulatory representatives to lead and support lifecycle management regulatory activities for the digital health and precision medicine portfolio, including change impact assessments, regulatory strategy alignment, and execution of required maintenance submissions/notifications to ensure ongoing compliance across markets. Provides strategic and tactical guidance to teams for the delivery of global regulatory strategies to support development and commercialization of biomarkers, diagnostic tests, devices and digital health tools to enhance the value of our products across therapeutic areas and to ensure goals/objectives are met.

30+ days ago

Regulatory Affairs Manager - Labeling Cardinal Health Inc

Mansfield, MA

Remote

$105,100–$150,100 / year

Symbol and Mark Management: Ensure the correct application of environmental symbols and marks, including those for the WEEE Directive, battery directives (e.g., crossed-out wheeled bin), recycling (e.g., "Green Dot," Mobius loop), and packaging material identification. Risk Management: Ability to apply risk management principles (ISO 14971) to the labeling process, identifying and mitigating risks associated with labeling errors, such as product recalls, shipping holds, or regulatory enforcement actions.

16 days ago

Senior Director, Regulatory Affairs Bicara Therapeutics

Boston, Massachusetts

FICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF--driven resistance mechanisms - ultimately designed to drive the deep, durable responses that may translate into better outcomes and survival for patients. Founded in 2020, we've built a global team of over 100 employees headquartered in Boston, with a clear focus on advancing our lead asset, ficerafusp alfa, or FICERA - a potentially first-in-class bifunctional EGFR-directed antibody combined with a TGF- ligand trap.

30+ days ago

Sr Regulatory Affairs Spec Medtronic Plc

Boston, MA

This role will partner closely with Geography Regulatory Affairs to support international submissions, government queries, registration documentation, product approval and clearance activities, product demand and release planning, and post-market regulatory compliance to help ensure continued product availability worldwide. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).

30+ days ago

Sr. Manager Regulatory Affairs CMC Alnylam Pharmaceuticals Inc

Cambridge, MA

$144,400–$195,400 / year

Helps to lead the interpretation of regulatory expectations for emerging modalities, including: siRNA and oligonucleotide therapeutics Conjugated delivery systems (e.g., GalNAc and other targeting ligands including biologic modalities) Complex drug substance and drug product configurations Helps to assess CMC implications of new technologies and modalities, including: Impact on product characterization, control strategies, and specifications Regulatory classification considerations (e.g., small-molecule vs biologic paradigms) Manages regulatory compliance activities including periodic regulatory reporting, review of technical documents, and providing regulatory assessments. Broad understanding of: Drug substance and drug product development Analytical characterization and control strategies Regulatory framework across major regions (e.g., US, EU, Japan, China) Strong ability to integrate scientific, technical, and regulatory considerations into clear strategies #LI-KB1 #LI-Hybrid U.S. Pay Range $144,400.00 - $195,400.00 The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting.

30+ days ago

Head of Regulatory Affairs North America Fresenius Medical Care

Waltham, Massachusetts

Working knowledge of the U.S. Food Drug and Cosmetic Act, and all associated regulations, especially the FDA medical device product approval processes, FDA legislature/regulation, post market approval requirements, and Quality Systems Regulations. Ensures all employees within the assigned team(s) understand and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations; establishing and maintaining effective internal systems and controls to promote compliance.

30+ days ago

Associate Director Regulatory Affairs – Vascular (on-site) Abbott

Westford, Massachusetts

Maintains expert working knowledge of laws, regulations and enforcement decisions related to Quality Assurance (QA), manufacturing and Research & Development (R&D) issues that may impact company operations and decision making; communicates such knowledge to all internal stakeholders. As a manager, the function of an Associate Director, Regulatory Affairs is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation.

30+ days ago

Vice President, Regulatory Affairs Rhythm Pharmaceuticals

Boston, MA

Full time

30+ days ago

Strategy Lead, CMC Mature, Regulatory Affairs GSK plc

Cambridge, MA

$113,850–$189,750 / year

GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment.

24 days ago

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Regulatory Affairs Jobs in Brookline, MA

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

Sr. Network Architect ECLARO

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

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

Regulatory Affairs Associate:$71,449+ YR Ajinomoto Cambrooke, Inc.

Associate Director Regulatory Affairs Viridian Therapeutics Inc

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

Executive Director, Regulatory Affairs Merck & Co Inc

Associate Director Regulatory Affairs Alnylam Pharmaceuticals Inc

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

Senior International Regulatory Affairs Specialist Butterfly Network Inc

Senior International Regulatory Affairs Specialist Butterfly Network

Associate Director, Regulatory Affairs CMC Skyhawk Therapeutics Inc

VP or SVP, Regulatory Affairs Acrivon Therapeutics Inc

Sr. Manager/Associate Director, Regulatory Affairs Oruka Therapeutics

Associate Director, Regulatory Affairs CMC CRISPR Therapeutics AG

Associate Director, Regulatory Affairs CMC CRISPR Therapeutics

Associate Director Regulatory Affairs CMC Alnylam Pharmaceuticals Inc

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

Associate Director, Regulatory Affairs CMC Voyager Therapeutics

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

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

Regulatory Affairs Specialist Careerscape

Vice President, Regulatory Affairs Rhythm Pharmaceuticals Inc

Associate Director, Regulatory Affairs, Advertising, Promotion & Labeling (RA-APL) Intellia Therapeutics Inc

Associate Director, Regulatory Affairs CMC Skyhawk Therapeutics

Regulatory Affairs Manager Dentsply Sirona

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

Associate Director, Global Regulatory Affairs - GI & Inflammation Takeda

Associate Director, Regulatory Affairs Entrada Therapeutics Inc

Regulatory Affairs & Compliance Lead Carrier Corporation

Director, Quality Assurance and Regulatory Affairs Meridian Bioscience Inc

Regulatory Affairs Strategy Director AstraZeneca Plc

Associate Director, Regulatory Affairs Entrada Therapeutics

Senior Regulatory Affairs Specialist Smith & Nephew Plc

Associate Director, Global Regulatory Affairs CMC Takeda Pharmaceutical Co Ltd

Chief of Staff, Senior Director Global Regulatory Affairs AstraZeneca Plc

Associate Director, Global Regulatory Affairs Marketed Products Takeda Pharmaceutical Co Ltd

Director, Business Development Regulatory Affairs Olympus Corp

Manager, Regulatory Affairs Monte Rosa Therapeutics, Inc

Associate Director, Global Regulatory Affairs, Precision Medicine & Digital Health Takeda

Regulatory Affairs Manager - Labeling Cardinal Health Inc

Senior Director, Regulatory Affairs Bicara Therapeutics

Sr Regulatory Affairs Spec Medtronic Plc

Sr. Manager Regulatory Affairs CMC Alnylam Pharmaceuticals Inc

Head of Regulatory Affairs North America Fresenius Medical Care

Associate Director Regulatory Affairs – Vascular (on-site) Abbott

Vice President, Regulatory Affairs Rhythm Pharmaceuticals

Strategy Lead, CMC Mature, Regulatory Affairs GSK plc

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