1,850 Results for

Regulatory Affairs Jobs in Massachusetts

Jobs

Associate Director US Legal Affairs and Corporate Counsel Lundbeck

Boston, MA

Provide strategic counsel on FDA regulations, the False Claims Act, the Anti-Kickback Statute, OIG guidance, the PhRMA Code, the Sunshine Act, privacy and data security laws and regulations, and competition law in connection with product labeling, promotional and non-promotional activities, marketing strategies, sales activities and compensation, pharmacovigilance, medical information, scientific exchange, and interactions with healthcare professionals. Serve as a strategic legal advisor to U.S. business functions, including Marketing, Medical Affairs, and Regulatory Affairs, providing legal counsel and guiding risk-based decision-making related to marketed pharmaceutical products, pipeline assets, and commercialization activities.

5 days ago

Medical Affairs Director - Rare Epilepsies Lundbeck

Boston, MA

This individual will partner closely with HEOR, Commercial, Customer Insights & Analytics, Patient Advocacy, Clinical Development, Compliance, Legal, Medical Affairs Operations, and Medical Affairs teams and external experts to ensure medical initiatives are scientifically rigorous, strategically aligned, compliant, and responsive to the evolving needs of the MSA community. This role will shape and advance the U.S. medical strategy by integrating scientific evidence, external stakeholder insights, cross-functional partnership, and high-quality medical execution to address the needs of people living with DEE, families, caregivers, healthcare professionals, payers, and policymakers.

13 days ago

Medical Affairs Director - Movement Disorders Lundbeck

Boston, MA

This individual will partner closely with HEOR, Commercial, Customer Insights & Analytics, Patient Advocacy, Clinical Development, Compliance, Legal, Medical Affairs Operations, and Medical Affairs teams and external experts to ensure medical initiatives are scientifically rigorous, strategically aligned, compliant, and responsive to the evolving needs of the MSA community. The role will lead and contribute across medical strategy, launch readiness, evidence and data dissemination, external expert engagement, publication and congress planning, medical and digital content development, scientific platform development, promotional medical review, agency/vendor management, budget oversight, and compliance review.

30+ days ago

Pharmaceutical Territory Sales Specialist Inizio Engage

Boston, MA

$60,000–$110,000 / year

Our passionate, global workforce augments local expertise and diverse mix of skills with data, science, and technology to deliver bespoke engagement solutions that help clients reimagine how they engage with their patients, payers, people, and providers to improve treatment outcomes. As part of our commitment to a fair and equitable hiring process, candidates are expected to complete all interview activities without the use of artificial intelligence tools or external assistance unless such assistance is authorized in advance by Inizio Engage or otherwise required in accordance with applicable law.

3 days ago

Senior Regulatory Affairs Specialist Boston Scientific

Marlborough, MA

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com-will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Your responsibilities will include: Reviews change notifications and performs regulatory impact assessment for product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings, and supports associated global submissions as needed.

15 days ago

Associate Director, Regulatory Affairs Third Rock Ventures LLC

Boston, MA

Support Phase II PoC & Phase III Readiness; Develop Phase II protocols with Go/No-Go criteria and strategies to de-risk psychiatry/neurology programs; Prepare Phase III regulatory groundwork, including End-of-Phase II (EOP2) meeting packages, safety database planning, and alignment with ICH guidelines for multi-regional trials. Design integrated early development strategic plans that bridge preclinical data (toxicology, pharmacology, CMC) with Phase I/II clinical objectives, addressing unique psychiatry/neurology challenges (e.g., blood-brain barrier delivery, placebo response mitigation).

18 days ago

Director, Regulatory Affairs Massachusetts League of Community Health Centers

Boston, MA

Full time
Quick Apply

Support the development of an array of training and technical assistance vehicles for various levels of health center stakeholders including written materials, webinars, and standing committees/meetings (including CFO Peer to Peer, CFO Forum, Governmental Affairs Committee) to provide timely information and support regarding health center regulatory policy changes. Essential Functions: This role requires a candidate who has the ability to:Regulatory PolicyMonitor and assess proposed and finalized rules, regulations, bulletins and other provider guidance issued by federal (e.g., CMS, HHS, SAMHSA) and state (e.g., EOHHS, MassHealth, DPH) agencies that impact health centers, their patients, and the communities they serve.

28 days ago

Associate Director, Regulatory Affairs Seaport Therapeutics

Boston, Massachusetts

17 days ago

Associate Director, Global Regulatory Affairs ImCheck Therapeutics SAS

Cambridge, MA

Building Relationships with Regulators: Build effective relationships with global regulators for professional communications on Ipsen strategy in relation to assigned products/disease areas. Communication: Ensures timely and accurate information of regulatory developments to all stakeholders (Management, governance committees, development and commercialization teams, Public Affairs, Legal, Investor Relations, etc.).

16 days ago

Principal Regulatory Affairs Specialist Boston Scientific

Marlborough, MA

Acts 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. The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com-will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role.

30+ days ago

Senior Director, Regulatory Affairs Repertoire Immune Medicines

Watertown, MA

$250,000–$300,000 / year

Reporting to the Chief Medical Officer, the Senior Director will own and be accountable for global regulatory strategy and execution from Phase 1/2 development through registrational planning in the U.S., EU, UK, and support activities in Asia-Pacific, partnering closely with Clinical Development, Clinical Operations, CMC, Quality, and external regulatory partners. Provide strategic regulatory guidance on early clinical development, including positioning Phase 1 programs for successful Phase 2 development and expedited programs, designations, and approval pathways (e.g., Fast Track, Breakthrough Therapy, Orphan Drug, PRIME, Accelerated Approval).

2 days ago

Sr. Regulatory Affairs Specialist - Recall and Post-Market Compliance (Hybird/Remote) Illumina Inc

Remote

$90,000–$135,000 / year

Key responsibilities include conducting timely assessments of potential adverse events and field actions to determine regulatory reportability, supporting MDR and recall decision-making, coordinating regulatory reporting activities, developing regulatory justifications and documentation, and ensuring compliance with applicable global regulations. The Senior Regulatory Affairs Specialist will be an instrumental member of the Regulatory Affairs team supporting on-market in vitro diagnostic (IVD) products in the United States and international markets.

19 days ago

Manager, Regulatory Affairs, CMC Stoke Therapeutics, Inc.

Bedford, MA

$145,000–$160,000 / year

Position Purpose: The Regulatory CMC Manager is responsible for contributing to the development of Stoke's products by supporting global CMC regulatory strategies, leading lifecycle management initiatives, and providing regulatory guidance to cross-functional teams for multiple programs. Key Responsibilities: Prepares and executes global regulatory CMC strategy for development programs and future commercial programs, including new applications, information amendments, annual reports, supplements/ variations, and responses to health authority questions.

11 days ago

Manager, Regulatory Affairs, CMC Stoke Therapeutics Inc

Bedford, MA

$145,000–$160,000 / year

11 days ago

Associate Director, Regulatory Affairs Alnylam Pharmaceuticals, Inc.

Cambridge, MA

The Associate Director of Regulatory Affairs Strategy will work on assigned programs with the respective Global Regulatory Portfolio Lead, Global Regulatory Lead and cross-functional team to lead and define the regulatory strategy, facilitate submission of data packages to the US FDA and other international health agencies (HA). Additional responsibilities include involvement in thewriting and oversight of regulatory submissions, coordinating all aspects of paper and electronic regulatory submissions, proactively keeping updated on regulatory requirements worldwide, and interpreting regulatory intelligence for the internal teams.

30+ days ago

INGENYX - Regulatory Affairs Specialist Teleflex Inc

$87,400–$131,100 / year

This role requires a detail-oriented individual who can effectively manage day-to-day labeling and UDI activities, maintain accurate regulatory product information, coordinate changes across multiple systems, and work collaboratively with Regulatory Affairs, Quality, IT, and other functions to support ongoing compliance. This role will support product registrations and regulatory maintenance activities, assess and implement regulatory changes, maintain compliant labeling and regulatory data, and assist with submissions and documentation required to support products in global markets.

15 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, Global Regulatory Affairs Ipsen SA

Cambridge, MA

16 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, Global Regulatory Affairs CMC 3316 Takeda Development Center Americas

Boston, Massachusetts

$154,400–$242,550 / 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 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.

30+ days ago

Get noticed by top employers!

Upload your resume to let employers know you're open to Regulatory Affairs job opportunities. Plus, receive relevant job recommendations in your inbox.

Create A Free Account

Regulatory Affairs Jobs in Massachusetts

Associate Director US Legal Affairs and Corporate Counsel Lundbeck

Medical Affairs Director - Rare Epilepsies Lundbeck

Medical Affairs Director - Movement Disorders Lundbeck

Pharmaceutical Territory Sales Specialist Inizio Engage

Senior Regulatory Affairs Specialist Boston Scientific

Associate Director, Regulatory Affairs Third Rock Ventures LLC

Director, Regulatory Affairs Massachusetts League of Community Health Centers

Associate Director, Regulatory Affairs Seaport Therapeutics

Associate Director, Global Regulatory Affairs ImCheck Therapeutics SAS

Principal Regulatory Affairs Specialist Boston Scientific

Senior Director, Regulatory Affairs Repertoire Immune Medicines

Sr. Regulatory Affairs Specialist - Recall and Post-Market Compliance (Hybird/Remote) Illumina Inc

Manager, Regulatory Affairs, CMC Stoke Therapeutics, Inc.

Manager, Regulatory Affairs, CMC Stoke Therapeutics Inc

Associate Director, Regulatory Affairs Alnylam Pharmaceuticals, Inc.

INGENYX - Regulatory Affairs Specialist Teleflex Inc

Associate Director, Regulatory Affairs CMC CRISPR Therapeutics AG

Associate Director, Global Regulatory Affairs Ipsen SA

Associate Director, Regulatory Affairs CMC CRISPR Therapeutics

Associate Director, Global Regulatory Affairs CMC 3316 Takeda Development Center Americas

Similar Job Searches