Senior Director, Regulatory Affairs

2 days ago


Boston, United States Proclinical Staffing Full time

Senior Director, Regulatory Affairs - Perm - Boston, MA

Proclinical is seeking a dynamic and strategic leader for the role of Senior Director of Regulatory Affairs. This role is pivotal in driving regulatory efforts for vaccine development programs.

Primary Responsibilities:

The successful candidate will manage the full lifecycle of global regulatory submissions and approvals, ensuring compliance across major markets.

Skills & Requirements:

  • Strong background in regulatory strategy, particularly in the field of infectious diseases and vaccines.
  • Proven experience in leading regulatory meetings and securing approvals.
  • Ability to manage complex regulatory portfolios.
  • Strong leadership skills and strategic thinking.

The Senior Director, Regulatory Affairs' responsibilities will be:

  • Develop and execute regulatory strategies for vaccine development programs.
  • Manage relationships with global health authorities.
  • Ensure product compliance across major markets.
  • Guide regulatory teams and manage submissions.
  • Mitigate risks while ensuring alignment with organizational priorities.

If you are having difficulty in applying or if you have any questions, please contact Nicholas Walker at n.walker@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.



  • Boston, United States Proclinical Staffing Full time

    Senior Director, Regulatory Affairs - Perm - Boston, MAProclinical is seeking a dynamic and strategic leader for the role of Senior Director of Regulatory Affairs. This role is pivotal in driving regulatory efforts for vaccine development programs. Primary Responsibilities:The successful candidate will manage the full lifecycle of global regulatory...


  • Boston, United States Proclinical Staffing Full time

    Senior Director, Regulatory Affairs - Perm - Boston, MAProclinical is seeking a dynamic and strategic leader for the role of Senior Director of Regulatory Affairs. This role is pivotal in driving regulatory efforts for vaccine development programs. Primary Responsibilities:The successful candidate will manage the full lifecycle of global regulatory...


  • Boston, Massachusetts, United States ProClinical Full time

    Senior Director, Regulatory Affairs **Job Summary:** Proclinical is seeking a seasoned regulatory professional to lead our vaccine development programs. As Senior Director, Regulatory Affairs, you will be responsible for driving regulatory efforts and ensuring compliance across major markets. **Key Responsibilities:** * Develop and execute regulatory...


  • Boston, United States Blackfield Associates Full time

    Blackfield Associates is exclusively partnered with a clinical stage biotech company that is pioneering in the development and approval of rare disease innovative treatments. We are looking to hire a Director, Regulatory Affairs to lead the US regulatory strategy firsthand. Regulatory Director Key Responsibilities:Provide strategic and operational leadership...


  • boston, United States Blackfield Associates Full time

    Blackfield Associates is exclusively partnered with a clinical stage biotech company that is pioneering in the development and approval of rare disease innovative treatments. We are looking to hire a Director, Regulatory Affairs to lead the US regulatory strategy firsthand. Regulatory Director Key Responsibilities:Provide strategic and operational leadership...


  • boston, United States Blackfield Associates Full time

    Blackfield Associates is exclusively partnered with a clinical stage biotech company that is pioneering in the development and approval of rare disease innovative treatments. We are looking to hire a Director, Regulatory Affairs to lead the US regulatory strategy firsthand. Regulatory Director Key Responsibilities:Provide strategic and operational leadership...


  • Boston, United States Blackfield Associates Full time

    Blackfield Associates is exclusively partnered with a clinical stage biotech company that is pioneering in the development and approval of rare disease innovative treatments. We are looking to hire a Director, Regulatory Affairs to lead the US regulatory strategy firsthand. Regulatory Director Key Responsibilities:Provide strategic and operational leadership...


  • Boston, Massachusetts, United States Fairway Consulting Group Full time

    Job Description:Job Title: Regulatory Affairs DirectorCompany: Fairway Consulting GroupJob Type: Full-timeLocation: RemoteJob Category: Healthcare, Life SciencesAbout Us: Fairway Consulting Group is a leading executive search firm specializing in healthcare and life sciences recruitment.Job Summary: We are seeking an experienced Regulatory Affairs Director...


  • Boston, Massachusetts, United States Fairway Consulting Group Full time

    Job Title: Director, Regulatory AffairsWe are seeking a highly experienced Director, Regulatory Affairs to join our team at Fairway Consulting Group. As a key member of our team, you will be responsible for providing strategic regulatory leadership and guidance to project teams, ensuring clinical trials are designed to meet regulatory requirements, and...


  • Boston, Massachusetts, United States Fairway Consulting Group Full time

    Director, Regulatory AffairsFairway Consulting Group is seeking a seasoned Director, Regulatory Affairs to join our team. As a key member of our client's organization, you will play a critical role in shaping the company's regulatory strategy and ensuring compliance with global regulations.Key Responsibilities:Develop and implement global regulatory...


  • Boston, Massachusetts, United States Fairway Consulting Group Full time

    Director, Regulatory AffairsFairway Consulting Group is seeking a seasoned Director, Regulatory Affairs to join our team. As a key member of our client's organization, you will play a critical role in supporting global regulatory strategy and execution on development programs.Key Responsibilities:Supports global regulatory strategy and execution on...


  • Boston, United States Fairway Consulting Group Full time

    Our client is a clinical stage biopharmaceutical company. They have asked us to assist them in their search for a Director, Regulatory Affairs. Major tasks and responsibilities include:Supports global regulatory strategy and execution on development programs, including maintaining strong relationships with cross-functional internal colleagues, regulatory...


  • Boston, United States CRISPR Therapeutics Full time

    Position SummaryThis position is a key leadership role for the development of the In Vivo franchise at CRISPR. Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients. As the Regulatory CMC lead for these programs, you will have the opportunity to...


  • Boston, Massachusetts, United States Piper Companies Full time

    Piper Companies is seeking a seasoned professional to lead the Neurology Regulatory Affairs team as Director of Regulatory Affairs (Ad & Promo). Key Responsibilities:• Develop and implement regulatory strategies for advertising and promotional materials• Collaborate with cross-functional teams to create compliant labeling, advertising, and promotional...


  • Boston, United States AstraZeneca Full time

    Are you passionate about science and experienced within regulatory affairs and drug development? Do you possess strategic and operational leadership skills? Then, join us at Cardiovascular, Renal or Metabolism (CVRM) regulatory affairs to get involved in the global regulatory strategies and support the research, development and commercialization of our...


  • Boston, United States Spencer Rigby Full time

    Spencer Rigby has partnered with a global leader in the development of innovative In Vitro Diagnostic (IVD) solutions and medical device software (SaMD) that empower healthcare providers to deliver better patient outcomes. As a growing company, we are seeking a highly skilled Senior Manager Regulatory Affairs Specialist.You will play a pivotal role in...


  • Boston, United States Spencer Rigby Full time

    Spencer Rigby has partnered with a global leader in the development of innovative In Vitro Diagnostic (IVD) solutions and medical device software (SaMD) that empower healthcare providers to deliver better patient outcomes. As a growing company, we are seeking a highly skilled Senior Manager Regulatory Affairs Specialist.You will play a pivotal role in...


  • boston, United States Spencer Rigby Full time

    Spencer Rigby has partnered with a global leader in the development of innovative In Vitro Diagnostic (IVD) solutions and medical device software (SaMD) that empower healthcare providers to deliver better patient outcomes. As a growing company, we are seeking a highly skilled Senior Manager Regulatory Affairs Specialist.You will play a pivotal role in...


  • Boston, United States Spencer Rigby Full time

    Spencer Rigby has partnered with a global leader in the development of innovative In Vitro Diagnostic (IVD) solutions and medical device software (SaMD) that empower healthcare providers to deliver better patient outcomes. As a growing company, we are seeking a highly skilled Senior Manager Regulatory Affairs Specialist.You will play a pivotal role in...


  • Boston, Massachusetts, United States Vertex Full time

    Job OverviewVertex is seeking a highly skilled Associate Director of Chemistry Manufacturing Controls to execute global regulatory CMC strategies for investigational and marketed products. This role will lead the preparation and filing of regulatory CMC submissions, manage interactions with Health Authorities, and provide regulatory guidance to...