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Regulatory Affairs Jobs in Bedford, MA

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Director of Scientific Affairs, Vaccines - EUROPE Gables Search Group

Cambridge, Cambridge

Remote

My client is expanding into a new area of biomarker technology and seeks a Director of Scientific Affairs focused on vaccines, with an emphasis on supporting clients' regulatory success. Identify unmet needs in vaccine development, and show where the technology can advance immune-response profiling and immunogenicity assessment.

13 days ago

Medical Affairs/Safety - Associate Director, Patient Advocacy and Engagement - Contract TalentBurst, Inc.

Cambridge, MA

$60–$83.74 / hour
Quick Apply

The Associate Director, Patient Advocacy and Engagement, Rare and Pipeline will play a critical role in driving patient-centric strategies and strengthening relationships with patient advocacy organizations primarily in US. Develop initiatives to enhance disease awareness and improve time to diagnosis, as well as educate the patient community so that they are empowered to actively engage with their healthcare provider in the management of their disease.

Today

Medical Affairs/Safety - Manager, PV Scientist - Contract TalentBurst, Inc.

Cambridge, MA

$113.55 / hour
Quick Apply

Collaborates proactively with study teams, cross-functional team members, external business partners and vendors to apply knowledge and analytical skills to problems in specific therapeutic areas. Contributes to activities related to the functioning of safety committees, including but not limited to, preparing reports, minutes and meeting documents; ensuring completion of action items; and, participating in the discussion of patient safety issues.

Today

Quality Data Management Analyst - Contract TalentBurst, Inc.

Burlington, MA

$48.56–$53.36 / hour
Quick Apply

Develop and maintain data dictionaries, data maps, data lineage documentation, and controlled data definitions supporting Quality metrics, dashboards, reports, and regulated business processes. Support data-related activities across enterprise GxP systems, including eQMS, document management, training management, complaint handling, ERP, PLM, LIMS , and other regulated applications.

Today

Research Aggregate Reports Specialist - Contract TalentBurst, Inc.

Cambridge, MA

$90–$96.77 / hour
Quick Apply

Collaborates proactively with study teams, cross-functional team members, external business partners and vendors to apply knowledge and analytical skills to problems in specific therapeutic areas. Contribute to activities related to the functioning of Alnylam safety committees, including but not limited to, preparing reports, minutes and meeting documents; ensuring completion of action items; and participating in the discussion of patient safety issues.

Today

Material Qualification Engineer - #26-25422 US Tech Solutions, Inc.

Lexington, MA

Quick Apply

The person in this role will be instrumental in working with other members of the Quality Assurance, Quality Control, Supplier Quality, Supply Chain, Manufacturing and Engineering organizations to develop and execute MQ studies and projects to enhance the manufacturing systems and processes to compliantly and efficiently achieve organizational goals. Education and Experience Requirements Essential: Bachelor's in Material Science, Mechanical, Biomedical or Chemical Engineering or related science or engineering field with a minimum of 4 years relevant experience or Master’s in related field with a minimum of 2 years relevant experience.

7 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.

30+ 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

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.

11 days ago

Associate Director / Director, Regulatory Affairs Treeline Biosciences Inc

Watertown, MA

Contribute to (Associate Director) or hold final accountability for (Director) regulatory documentation, ensuring adherence to FDA and other global health authority specifications and timelines, including submissions, correspondence, and approvals, and ensuring accurate and organized records. Unsolicited resumes sent to Treeline Biosciences from recruiters do not constitute any type of relationship between the recruiter and Treeline Biosciences and do not obligate Treeline Biosciences in any way to pay fees should we hire from those resumes.

30+ days ago

Associate Director / Director, Regulatory Affairs Treeline Biosciences, Inc.

Watertown, MA

$175,000–$206,015 / year

17 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.

22 days ago

Associate Director, Regulatory Affairs Alnylam Pharmaceuticals Inc

Cambridge, MA

$170,900–$231,300 / year

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.

21 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

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

Bedford, MA

$181,000–$213,000 / year

22 days ago

Director, Global Regulatory Affairs, Neuroscience 3316 Takeda Development Center Americas

Boston, Massachusetts

$177,000–$278,080 / year

Demonstrates acceptable 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. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible.

30+ 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.

22 days ago

Principal Regulatory Affairs Specialist Boston Scientific Corp

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 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.

8 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

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Regulatory Affairs Jobs in Bedford, MA

Director of Scientific Affairs, Vaccines - EUROPE Gables Search Group

Medical Affairs/Safety - Associate Director, Patient Advocacy and Engagement - Contract TalentBurst, Inc.

Medical Affairs/Safety - Manager, PV Scientist - Contract TalentBurst, Inc.

Quality Data Management Analyst - Contract TalentBurst, Inc.

Research Aggregate Reports Specialist - Contract TalentBurst, Inc.

Material Qualification Engineer - #26-25422 US Tech Solutions, Inc.

Senior Regulatory Affairs Specialist Boston Scientific

Manager, Regulatory Affairs Program Canadian Nuclear Laboratories Ltd

Director, Regulatory Affairs Massachusetts League of Community Health Centers

Associate Director / Director, Regulatory Affairs Treeline Biosciences Inc

Associate Director / Director, Regulatory Affairs Treeline Biosciences, Inc.

Senior Manager, Regulatory Affairs, CMC Stoke Therapeutics Inc

Associate Director, Regulatory Affairs Alnylam Pharmaceuticals Inc

Associate Director, Regulatory Affairs CMC CRISPR Therapeutics AG

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

Director, Global Regulatory Affairs, Neuroscience 3316 Takeda Development Center Americas

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

Principal Regulatory Affairs Specialist Boston Scientific Corp

Senior Vice President Regulatory Affairs and Quality Verastem Inc

Associate Director, Regulatory Affairs Parabilis Medicines

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