Senior Vice President, Regulatory Affairs Lead

8 hours ago


Waltham, Massachusetts, United States Meet Full time
Regulatory Affairs Leadership Opportunity

Vice President/Senior Vice President, Regulatory Affairs

*Based in New England or flexible to travel*

Key Responsibilities:
  • Provide strategic direction to Regulatory Affairs, Clinical Quality, and Medical Writing departments, leading the Regulatory Affairs group in hiring, mentoring, and staff management.
  • Drive the planning and implementation of meetings with regulatory authorities, effectively representing the client's regulatory interactions.
  • Direct and negotiate submissions (IND, CTA, BLA, MAA, etc.) and approvals with regulatory authorities.
Key Qualifications:
  • BS required, MS/PhD/PharmD preferred.
  • 15+ years of Regulatory Affairs experience.
  • Experience in virology/infectious disease required.
  • Experience leading programs from Initial IND/CTA through BLA/MAA.
  • Extensive Health Authority interaction experience (FDA, EMA, Health Canada).


  • Waltham, Massachusetts, United States Meet Full time

    Senior Vice President of Regulatory Affairs*Candidates should be located in New England or must be open to travel*Primary ResponsibilitiesProvide strategic oversight and regulatory guidance to the Regulatory Affairs, Clinical Quality, and Medical Writing teams while leading the Regulatory Affairs division, including recruitment, mentorship, and team...


  • Waltham, Massachusetts, United States Global Partners Full time

    Position Overview:The Senior Vice President of Legal Affairs will play a pivotal role in shaping both short-term and long-term strategies that influence the legal operations of the organization. This position will act as the principal in-house legal advisor for the Human Resources and Information Technology departments, while also providing support to...


  • Waltham, Massachusetts, United States Alkermes, Inc. Full time

    About the RoleAlkermes, Inc. is seeking a highly skilled Senior Manager to join our Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs team. As a key member of our team, you will be responsible for supporting commercial CMC and GMP activities for contracted manufactured products and our European office.Key ResponsibilitiesRegulatory...


  • Waltham, Massachusetts, United States Ventus Therapeutics Full time

    About Ventus Therapeutics:We are a biopharmaceutical company leveraging cutting-edge structural biology and computational chemistry tools to develop novel small molecule medicines for challenging targets, with an initial focus on immunology, inflammation, and neurology.Our proprietary drug discovery platform, ReSOLVE, enables us to discover and develop...


  • Waltham, Massachusetts, United States Global Partners Full time

    About the RoleWe are seeking a highly skilled and experienced Vice President of Legal Affairs to join our team at Global Partners LP. As a key member of our leadership team, you will play a critical role in developing and implementing legal strategies that support our business objectives.Key ResponsibilitiesServe as primary legal counsel to our Finance and...


  • Waltham, Massachusetts, United States Ventus Therapeutics Full time

    About Ventus Therapeutics:We are a biopharmaceutical company leveraging cutting-edge structural biology and computational chemistry tools to develop innovative small molecule medicines for challenging targets. Our initial focus areas include immunology, inflammation, and neurology.Our proprietary drug discovery platform, ReSOLVE, enables us to discover and...


  • Waltham, Massachusetts, United States Global Partners Full time

    About the RoleWe are seeking a highly skilled and experienced Vice President of Legal Affairs to join our team at Global Partners LP. As a key member of our leadership team, you will play a critical role in developing and implementing legal strategies that support our business objectives.Key ResponsibilitiesServe as primary legal counsel to our Finance and...


  • Waltham, Massachusetts, United States AbbVie Full time

    Company Overview:AbbVie is dedicated to discovering and delivering innovative therapies that address significant health challenges today and in the future.Our goal is to positively impact lives across several key therapeutic areas, including immunology, oncology, neuroscience, and eye care, as well as through our Allergan Aesthetics portfolio.For further...


  • Waltham, Massachusetts, United States Benchmark Senior Living Full time

    Company Overview:Benchmark Senior Living, established in 1997, is recognized as the premier provider of senior housing solutions in New England. With headquarters in Waltham, MA, the organization is dedicated to delivering exceptional services and care, embodying the comfort and warmth of home. Benchmark excels in various service areas, including independent...


  • Waltham, Massachusetts, United States Alkermes, Inc. Full time

    Position Overview: In this pivotal role, reporting to the Senior Director of Regulatory Affairs, the Senior Manager of Regulatory Affairs and Compliance will oversee the provision of expert regulatory guidance pertaining to the dissemination of information regarding designated Alkermes products and relevant therapeutic areas. This position collaborates...


  • Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Job Title: Associate Director, Regulatory CMCThe Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) plays a pivotal role in executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval. This position supports Dyne's clinical registration, commercial development, and...


  • Waltham, Massachusetts, United States Alkermes, Inc. Full time

    Position Overview: Under the guidance of the Senior Director of Regulatory Affairs for Advertising, Promotion & Labeling, the Senior Manager, Regulatory Affairs in Advertising will play a pivotal role in delivering comprehensive regulatory guidance concerning the dissemination of information related to designated Alkermes products and associated medical...


  • Waltham, Massachusetts, United States Meet Full time

    Regulatory Affairs Leadership OpportunityWe are seeking a seasoned Regulatory Affairs professional to lead our team and drive strategic direction in this critical role.Key Responsibilities:Provide regulatory leadership and strategic direction to Regulatory Affairs, Clinical Quality, and Medical Writing departmentsDrive planning and implementation of meetings...


  • Waltham, Massachusetts, United States Meet Full time

    Regulatory Affairs Leadership OpportunityWe are seeking a seasoned Regulatory Affairs professional to lead our team and drive strategic direction in this critical role.Key Responsibilities:Provide regulatory leadership and strategic direction to Regulatory Affairs, Clinical Quality, and Medical Writing departmentsDrive planning and implementation of meetings...


  • Waltham, Massachusetts, United States Weber & Company Full time

    Executive Director Regulatory AffairsJob Summary:Weber & Company is seeking an experienced Executive Director Regulatory Affairs to lead our client's regulatory affairs team in Greater Boston. As a key member of the leadership team, you will be responsible for developing and implementing a regulatory strategy that accelerates product approvals and maintains...


  • Waltham, Massachusetts, United States Trebla Talent Full time

    Job Summary:We are seeking a highly experienced Executive Director, Regulatory Affairs to join our team at Trebla Talent. As a pivotal leader, you will drive strategic regulatory decisions across our entire portfolio, leading a growing regulatory team and reporting directly to the c-suite.Key Responsibilities:Develop and implement regulatory strategies to...


  • Waltham, Massachusetts, United States Trebla Talent Full time

    Job Title: Executive Director, Regulatory AffairsCompany: Trebla TalentLocation: Massachusetts - HybridJob Type: Full-timeAbout the Company:Trebla Talent is a leading recruitment agency specializing in placing top talent in the biotech and pharmaceutical industries.Job Description:We are seeking an experienced Executive Director to lead our Regulatory...


  • Waltham, Massachusetts, United States AbbVie Full time

    Company Overview:At AbbVie, our mission is to innovate and provide groundbreaking medicines and solutions that tackle significant health challenges today while preparing for the medical hurdles of tomorrow.We aim to make a substantial difference in the lives of individuals across various critical therapeutic domains, including immunology, oncology,...


  • Waltham, Massachusetts, United States Trebla Talent Full time

    Role:We are seeking a seasoned Regulatory Affairs expert to lead our team and drive strategic decisions across our portfolio.Company Overview:Trebla Talent is proud to partner with a pre-IPO, clinical-stage biotech company that is revolutionizing cancer and autoimmune treatments through innovative immunotherapies.Key Responsibilities:As the Executive...


  • Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Job SummaryThe Associate Director, Regulatory Affairs CMC is a critical role at Dyne Therapeutics, responsible for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval.Key ResponsibilitiesLead CMC regulatory execution for specific programs at all stages of developmentProvide strategic...