1,169 Results for

Regulatory Affairs Jobs in Medford, MA

Jobs

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

Director Medical Affairs - Clinical Microbiology Waters Corporation

Anywhere, MA

The Director is expected to bring deep diagnostic and laboratory expertise, strong business acumen, and a collaborative leadership style to advance medical credibility, innovation, and patient impact across Waters Advanced Diagnostics. This individual translates unmet customer and patient needs, evolving clinical practice, and real-world evidence into actionable medical strategies that strengthen product differentiation, support lifecycle decisions, and enable successful development and adoption of innovative diagnostic solutions.

10 days ago

Senior Manager, Medical Affairs Operations - Remote Agios Pharmaceuticals

Boston, MA

Remote

$131,035–$196,553 / year

Manage the execution of Agios’ patient advocacy conference plans for PK deficiency, thalassemia, and sickle cell disease; participate in cross-functional planning meetings; obtain compliance approval for related materials; and attend virtual and in-person conferences, when needed. Provide operational and project management support to the US patient advocacy team, ensuring smooth day-to-day coordination across priorities, stakeholders, and deliverables, and flex to support various other functions within Medical Affairs as needs arise.

17 days ago

Associate Director, State Government Affairs - Remote Agios Pharmaceuticals

Boston, MA

Remote

$153,541–$230,312 / year

The current base salary range for this position is expected to be between $153,541 and $230,312 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. Our team’s proven track record of executional excellence, combined with our depth of expertise and dedication, enables us to develop innovative medicines that reflect the priorities of rare disease communities.

17 days ago

Director, Regulatory Strategy (Pediatrics) - Remote Agios Pharmaceuticals

Boston, MA

Remote

$183,549–$275,324 / year

The current base salary range for this position is expected to be between $183,549 and $275,324 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. This individual will lead cross-functional teams in preparing and overseeing development of compliant, high quality, nonclinical and clinical global regulatory submissions to support development, registration, or life cycle management activities.

17 days ago

Director/Senior Director, Regulatory Labeling Strategy, Advertising, and Promotion, Regulatory Agios Pharmaceuticals

Cambridge, MA

$229,562–$344,342 / year

The current base salary range for this position at the Director level is expected to be between $183,549 and $275,324 annualized and the current base salary range for this position at the Senior Director level is expected to be between $229,562 and $344,342 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. This individual will partner cross-functionally with Legal, Commercial, Corporate Communications, and Medical, as well as other cross-functional stakeholders within the Research and Development organization, to enable compliant, effective messaging, development of labeling, and promotional and non-promotional materials to supports business objectives while protecting the company’s integrity and reputation.

17 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.

7 days ago

Senior Director, Program Leader, Corporate Strategy Agios Pharmaceuticals

Cambridge, MA

$229,562–$344,345 / year

Demonstrated ability to drive successful product launch and commercialization of innovative, first-in-class therapies, including lifecycle management (LCM) planning and execution; experience leading programs from late-stage development through commercial readiness and post-launch LCM strategies strongly desired. Define and continuously evolve the Target Product Profile, Clinical Development Plan, regulatory pathway, market access strategy, and commercial positioning in close partnership with cross-functional leaders and aligned with patient needs.

17 days ago

Project Manager II Waters Corporation

Milford, MA

As a Project Manager II, you will partner closely with Product Management, Engineering, Operations, and other cross-functional teams to ensure projects are delivered on time, within scope, and aligned with portfolio priorities. • Support and manage cross-functional project teams including Product Management, Engineering, Operations, Regulatory Affairs, Quality Assurance, and Finance.

10 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.

14 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. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

14 days ago

Director, Global Trade Waters Corporation

Milford, MA

The Director, Global Trade Compliance & Trade Operations is a senior enterprise leader responsible for defining and advancing the company’s global trade strategy, integrating regulatory compliance with world-class import/export operations. This role operates at the intersection of risk governance and supply chain execution, ensuring the organization can scale globally while maintaining strict adherence to international trade laws.

9 days ago

Medical Director, Sickle Cell Disease, Clinical Development Agios Pharmaceuticals

Boston, MA

$221,600–$369,333 / year

The current base salary range for this position is expected to be between $221,600 and $369,333 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. Follow important developments and relevant trends in scientific literature and develop/maintain contracts with external experts to support understanding of the candidate drug effects and to gain strategic insights to the further development and placement of study and overall program.

17 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

Associate Director/ Director, Patient Marketing - Remote Agios Pharmaceuticals

Boston, MA

Remote

$183,549–$275,324 / year

The current base salary range for this position at the Associate Director level is expected to be between $153,541 and $230,312 annualized and the current base salary range for this position at the Director level is expected to be between $183,549 and $275,324 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. The Associate Director/Director, Patient Marketing will focus on developing and executing the patient strategy in preparation for the future launch of mitapivat, currently in development for sickle cell disease, a vastly underserved community.

17 days ago

Physician - Staff Radiologist Department of Veterans Affairs

Jamaica Plain, MA

3) Non-US residency training programs followed by a minimum of three years of verified independent practice in the United States (performing under a full and unrestricted license) performing duties related to the position they are applying for (United States fellowships would be creditable towards this requirement), which the local Medical Staff Executive Committee deems to have provided the applicant with appropriate professional training and believes has exposed the Physician to an appropriate range of patient care experiences. The nuclear medicine service skills desired include, but are not limited to, interpretation of general nuclear medicine studies, nuclear medicine cardiac studies, and PET/CT studies in addition to limited non-imaging uses of unsealed sources such as thyroid probe uptake measurements.

1 day ago

Associate Director, Scientific Communications & Publications - Remote Agios Pharmaceuticals

Boston, MA

Remote

$153,000–$230,000 / year

Operating at the intersection of strategy and execution, this role partners closely with cross-functional colleagues and external experts to deliver high‑impact publications and scientific communications that advance both patient care and scientific dialogue. The current base salary range for this position is expected to be between $153,000 and $230,000 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators.

17 days ago

Senior Director, Clinical Education and Events Dentsply Sirona

Boston, MA

This leader serves as the senior clinical authority for NAM education, ensuring programs meet the needs of practicing clinicians while supporting business priorities, product adoption, and long term customer trust. • Oversee planning and execution of clinical educational events (e.g., courses, workshops, symposia, webinars), ensuring end-to-end operational excellence (logistics, faculty coordination, attendee experience) and alignment to learning objectives.

12 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

Vice President, Regulatory Affairs Rhythm Pharmaceuticals

Boston, Massachusetts

30+ 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

Sr. Specialist, Regulatory Affairs LeMaitre

Burlington, Massachusetts

$110,000–$150,000 / year
Full time

Provide support to currently marketed products including: reviewing of engineering change orders, labeling, promotional material, product changes and documentation for changes requiring regulatory approval. Candidate will prepare regulatory submissions for new products/product changes to ensure timely approval for market release and will follow up with regulatory agencies on these submissions.

23 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

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

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

Sr. Specialist, Regulatory Affairs LeMaitre Vascular Inc

Burlington, MA

$110,000–$150,000 / year

Provide support to currently marketed products including: reviewing of engineering change orders, labeling, promotional material, product changes and documentation for changes requiring regulatory approval. The Regulatory Affairs Manager will report to the VP of Regulatory Affairs and have the following primary responsibilities: Responsible for preparation of regulatory submissions, including FDA 510(K), CE Technical Documentations, Canadian Device Applications, etc.

9 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

Senior Manager, Regulatory Affairs Kymera Therapeutics

Watertown, MA

$145,000–$215,000 / year

Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Reporting to the Director of Regulatory Affairs, the Senior Manager will independently lead regulatory activities at the study level, acting as the regulatory representative on cross-functional teams while driving execution of program regulatory strategies.

13 days ago

Director, Regulatory Affairs – Clinical Strategy Azurity Pharmaceuticals - US

Woburn, MA

Development and implementation of clinical regulatory strategies and tactics,including but not limited to, Modeling Informed Drug Development (MIDD), real- world data (RWD)/real-world evidence (RWE), and meta-analysis, for pipeline and commercial assets,while considering FDA and other health authority clinical and regulatory requirements. As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Director – Clinical Strategy will conduct in depth analysis of regulatory and clinical information to develop complex strategies supporting potential drug products for development and commercial drug products for expansion of the Azurity portfolio of medications.

30+ days ago

Manager, Regulatory Affairs Advertising & Promotion (Work from Home) Parexel

Massachusetts

This individual will act as a trusted advisor, collaborating across cross-functional teams within a large, dedicated client partnership—helping to influence regulatory strategy and deliver meaningful impact, all while working remotely. This role extends beyond execution, requiring a proactive leader who can independently review materials, interpret evolving FDA guidance, and pivot regulatory strategy to support business objectives while mitigating risk.

17 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

Director, Regulatory Affairs - Clinical Strategy Azurity Pharmaceuticals Inc

Woburn, MA

Brief Team/Department Description: As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Director - Clinical Strategy will conduct in-depth analysis of regulatory and clinical information to develop complex strategies supporting potential drug products for development and commercial drug products for expansion of the Azurity portfolio of medications. Principle Responsibilities: • Development and implementation of clinical regulatory strategies and tactics, including but not limited to, Modeling Informed Drug Development (MIDD), real-world data (RWD)/real-world evidence (RWE), and meta-analysis, for pipeline and commercial assets, while considering FDA and other health authority clinical and regulatory requirements.

30+ 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

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

Senior Manager Regulatory Affairs Chemistry Manufacturing and Controls CMC AbbVie Inc

Waltham, MA

Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations brand teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions. The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients to deliver biologics products to patients, including mAb, ADC and cell & gene therapies.

15 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

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

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

Senior Manager, Regulatory Affairs NAM Straumann Holding AG

This role leads the planning, preparation, and submission of regulatory filings (e.g., Pre-Submissions, 510(k)s, PMAs, PMA Annual Reports, IDEs, and License Applications) and serves as a key regulatory partner to cross-functional teams. This role collaborates closely with global regulatory counterparts within the Straumann Group (e.g., Medentika, Neodent, Anthogyr, Dental Wings, etc.) and manages/develops regulatory staff and/or leads complex regulatory projects.

30+ 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

Director, Global Regulatory Affairs Process Excellence and Transformation Vertex Pharmaceuticals

Boston, Massachusetts

As a key member of the GRA Process Optimization Network (GPON), this role consults with cross-team representatives to diagnose operational challenges and deliver scalable, sustainable solutions. The Director, Global Regulatory Affairs Process Excellence & Transformation leads complex, cross-functional operational excellence initiatives across Global Regulatory Affairs (GRA).

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

Senior Manager, Regulatory Affairs Getinge AB

Nashua, NH

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.

13 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

Executive Director, Global Regulatory Affairs CMC Early Development Takeda Pharmaceutical Co Ltd

Boston, MA

$238,000–$374,000 / year

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).

20 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

Senior Manager, Regulatory Affairs Kymera Therapeutics Inc

Watertown, MA

$145,000–$215,000 / year

21 days ago

Manager, Regulatory Affairs Deciphera Pharmaceuticals Inc

Waltham, MA

$116,000–$160,000 / year

The Manager, Regulatory Affairs will partner cross-functionally to support high-quality regulatory submissions and help drive successful interactions with global health authorities. Our base salary is just one component of Deciphera's competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable).

30+ days ago

Head of Regulatory Affairs Pulpdent Corp

Pulpdent is third-generation family-owned business that is widely respected for its innovative products and authentic company culture, which promotes work-life balance, employee retention, and product excellence. The Head of Regulatory Affairs will lead and evolve Pulpdent's global regulatory strategy across the full product lifecycle-from R&D and commercialization to quality assurance and post-market surveillance.

22 days ago

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Regulatory Affairs Jobs in Medford, MA

Regulatory Affairs Manager Dentsply Sirona

Director Medical Affairs - Clinical Microbiology Waters Corporation

Senior Manager, Medical Affairs Operations - Remote Agios Pharmaceuticals

Associate Director, State Government Affairs - Remote Agios Pharmaceuticals

Director, Regulatory Strategy (Pediatrics) - Remote Agios Pharmaceuticals

Director/Senior Director, Regulatory Labeling Strategy, Advertising, and Promotion, Regulatory Agios Pharmaceuticals

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

Senior Director, Program Leader, Corporate Strategy Agios Pharmaceuticals

Project Manager II Waters Corporation

Associate Director, Clinical Assay Strategy, Flu CSL Seqirus

Senior Director, Immunology and Translation CSL Behring

Director, Global Trade Waters Corporation

Medical Director, Sickle Cell Disease, Clinical Development Agios Pharmaceuticals

Sr. Network Architect ECLARO

Associate Director/ Director, Patient Marketing - Remote Agios Pharmaceuticals

Physician - Staff Radiologist Department of Veterans Affairs

Associate Director, Scientific Communications & Publications - Remote Agios Pharmaceuticals

Senior Director, Clinical Education and Events Dentsply Sirona

Vice President, Regulatory Affairs Rhythm Pharmaceuticals Inc

Vice President, Regulatory Affairs Rhythm Pharmaceuticals

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

Sr. Specialist, Regulatory Affairs LeMaitre

Associate Director Regulatory Affairs Viridian Therapeutics Inc

Manager, Regulatory Affairs Monte Rosa Therapeutics, Inc

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

Sr. Specialist, Regulatory Affairs LeMaitre Vascular Inc

Sr. Manager Regulatory Affairs CMC Alnylam Pharmaceuticals Inc

Senior Manager, Regulatory Affairs Kymera Therapeutics

Director, Regulatory Affairs – Clinical Strategy Azurity Pharmaceuticals - US

Manager, Regulatory Affairs Advertising & Promotion (Work from Home) Parexel

Director, Business Development Regulatory Affairs Olympus Corp

Director, Regulatory Affairs - Clinical Strategy Azurity Pharmaceuticals Inc

Senior Director, Regulatory Affairs Bicara Therapeutics

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

Senior Manager Regulatory Affairs Chemistry Manufacturing and Controls CMC AbbVie Inc

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

Regulatory Affairs Manager - Labeling Cardinal Health Inc

Sr Regulatory Affairs Spec Medtronic Plc

Senior Manager, Regulatory Affairs NAM Straumann Holding AG

Executive Director, Regulatory Affairs Merck & Co Inc

Director, Global Regulatory Affairs Process Excellence and Transformation Vertex Pharmaceuticals

Associate Director Regulatory Affairs Alnylam Pharmaceuticals Inc

Senior Manager, Regulatory Affairs Getinge AB

Strategy Lead, CMC Mature, Regulatory Affairs GSK plc

Executive Director, Global Regulatory Affairs CMC Early Development Takeda Pharmaceutical Co Ltd

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

Senior Manager, Regulatory Affairs Kymera Therapeutics Inc

Manager, Regulatory Affairs Deciphera Pharmaceuticals Inc

Head of Regulatory Affairs Pulpdent Corp

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