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Regulatory Affairs Jobs in Newton, MA

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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.

6 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).

9 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.

19 days ago

Associate Director, Regulatory Affairs Seaport Therapeutics

Boston, Massachusetts

8 days ago

Manager, Regulatory Affairs Program Canadian Nuclear Laboratories Ltd

Burlington, MA

Managing the work of and leading technical specialists within the Branch, elsewhere within CNL, and external to CNL (as required) to ensure that requests for independent technical review of technical documentation submitted by Proponents, or requests by Proponents for independent review of activities at nuclear facilities at CNL sites, are accommodated and dispositioned effectively and efficiently with due regard to timely review while maintaining technical breadth and depth and not compromising safety. In consultation with the SRC Secretariat and Proponents, planning independent technical reviews, accepting hazard categories following the review of proposals by Proponents, liaising with the NCS Panel Chair and the NCS Panel Technical Secretary, chairing SRC independent technical review meetings, and ensuring that final review comments that are compiled from SRC technical reviewers are consistent and harmonized before they are sent to the Proponents.

30+ 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.).

7 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

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.

2 days ago

Associate Director Global Regulatory Affairs (CMC) - Cambridge, MA 02139 (Remote) Alpha Business Solutions

Cambridge, MA

Remote

Quick Apply

The ideal candidate will be a senior-level Pharmacovigilance/Drug Safety professional with strong hands-on Signal Management experience, global regulatory knowledge, and the ability to operate as a subject matter expert across cross-functional teams Partner with Data Sciences, Global Regulatory Affairs, Medical Safety, and other PSPV functions to develop and improve signal management processes.

30 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.

10 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

Senior Manager, Regulatory Affairs, CMC Stoke Therapeutics, Inc.

Bedford, MA

$181,000–$213,000 / year

Position Purpose: The Regulatory CMC Senior 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.

9 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

Manager, Regulatory Affairs (Companion Diagnostics) Quest Diagnostics Inc

Marlborough, MA

Remote

Job DescriptionThe Regulatory Affairs Manager will create, evaluate and execute domestic and/or international regulatory tasks related to the following: global submissions, technical file compilation, facility registrations, special projects and strategy to drive market growth worldwide. This is a Remote opportunity Pay Range: $120,000 - $150,000/ year, 10% Bonus (The final offer and compensation package for this role may vary depending on the candidate''s geographic location.)Salary offers are based on a wide range of factors including relevant skills, training, experience, education, and, where applicable, certifications obtained.

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

Senior Vice President Regulatory Affairs and Quality Verastem Inc

Boston, MA

Establish and maintain a state of inspection readiness across the organization, ensuring continued compliance for commercial products while proactively preparing the company, its systems, and external partners for regulatory submission and pre-approval inspections associated with upcoming product filings. Position Summary The Senior Vice President of Regulatory Affairs and Quality is a member of Verastem Oncologys leadership team and provides enterprise-wide leadership for global regulatory strategy and product quality.

16 days ago

Associate Director, Global Regulatory Affairs Ipsen SA

Cambridge, MA

7 days ago

Associate Director, Regulatory Affairs Parabilis Medicines

Cambridge, MA

$170,000–$195,000 / year

We are fiercely independent as a leader in defying the limitations of current therapeutic modalities, and interdependent as a team as we work collaboratively to shift drug discovery paradigms and provide patients with better treatment options. Parabilis Medicines is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for patients with serious diseases by unlocking biologically important targets long considered undruggable.

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

Digital Health Regulatory Affairs Manager Johnson & Johnson

Danvers, MA

Remote

$117,000–$201,250 / year

Your core focus will be regulatory leadership for Digital Health across Heart Recovery's cardio-pulmonary product portfolio: the Impella Ecosystem (Heart Pumps), PreCardia (cardio-renal unloading - decompensated heart failure (ADHF), restoring kidney function) and Breethe (ECMO: respiratory failure) with particular emphasis on: Cybersecurity. Required Skills: Preferred Skills: Analytical Reasoning, Business Writing, Coaching, Compliance Risk, Fact-Based Decision Making, Industry Analysis, Legal Support, Process Improvements, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Strategic Thinking, Technical Credibility.

23 days ago

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Regulatory Affairs Jobs in Newton, MA

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

Manager, Regulatory Affairs Program Canadian Nuclear Laboratories Ltd

Associate Director, Global Regulatory Affairs ImCheck Therapeutics SAS

Principal Regulatory Affairs Specialist Boston Scientific

Manager, Regulatory Affairs, CMC Stoke Therapeutics Inc

Associate Director Global Regulatory Affairs (CMC) - Cambridge, MA 02139 (Remote) Alpha Business Solutions

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

Associate Director, Regulatory Affairs Alnylam Pharmaceuticals, Inc.

Senior Manager, Regulatory Affairs, CMC Stoke Therapeutics, Inc.

Associate Director, Regulatory Affairs CMC CRISPR Therapeutics AG

Manager, Regulatory Affairs (Companion Diagnostics) Quest Diagnostics Inc

Associate Director, Regulatory Affairs CMC CRISPR Therapeutics

Senior Vice President Regulatory Affairs and Quality Verastem Inc

Associate Director, Global Regulatory Affairs Ipsen SA

Associate Director, Regulatory Affairs Parabilis Medicines

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

Digital Health Regulatory Affairs Manager Johnson & Johnson

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