Vice President Regulatory Affairs

3 weeks ago

Boston, United States Albion Rye Associates Full time

Company Overview:


Join a cutting-edge biotechnology company in Boston, committed to pioneering breakthrough therapies that address unmet medical needs. Our team is passionate about translating science into therapeutic solutions, and we are looking for a highly experienced Vice President of Regulatory Affairs to lead our regulatory strategy and guide us through key regulatory milestones.


Position Summary:


The Vice President of Regulatory Affairs will be responsible for overseeing and executing the company’s regulatory strategy across all phases of product development, from preclinical to commercial stages. This individual will play a critical role in ensuring successful regulatory filings, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Biologics License Applications (BLAs) with the U.S. Food and Drug Administration (FDA). The ideal candidate will have a strong background in FDA regulatory submissions, a comprehensive understanding of the biotechnology regulatory landscape, and an established record of working with global regulatory bodies.


Key Responsibilities:


  • Develop, lead, and implement global regulatory strategies for the company’s pipeline products, with a focus on aligning with FDA and international regulatory requirements.
  • Oversee the preparation, review, and submission of all regulatory filings, including INDs, NDAs, BLAs, and related submissions, ensuring compliance with regulatory standards.
  • Collaborate closely with Research & Development, Clinical, Quality, and Manufacturing teams to ensure regulatory requirements are integrated into development and commercialization processes.
  • Ensure compliance with all applicable FDA regulations and international regulatory requirements throughout the lifecycle of each product.
  • Serve as the primary liaison with regulatory agencies (FDA, EMA, etc.), managing communications, submission responses, and regulatory meetings to facilitate timely approvals and support regulatory filings.
  • Identify regulatory risks and provide strategic guidance on risk mitigation, regulatory pathways, and opportunities to accelerate development timelines.
  • Establish and maintain robust regulatory processes and policies to support product development and commercialization objectives.


Required Qualifications:


  • 15+ years of experience in Regulatory Affairs within the biotechnology or pharmaceutical industry.
  • Proven experience with the FDA regulatory process, including IND, NDA, and BLA submissions and approval processes.
  • Demonstrated experience in a senior regulatory leadership role, with a track record of effective cross-functional collaboration and team leadership.
  • In-depth understanding of global regulatory standards and processes (e.g., FDA, EMA) and familiarity with working across all phases of drug development.
  • Strong strategic and analytical skills, with the ability to manage complex projects, interpret regulatory guidelines, and provide actionable recommendations.
  • Exceptional written and verbal communication skills, with the ability to effectively communicate regulatory concepts and strategies to both technical and non-technical stakeholders.


Preferred Qualifications:


  • Advanced degree (PhD, PharmD, MD, or equivalent) in a related scientific discipline.
  • Experience working with regulatory authorities outside of the U.S., including EMA and other international bodies.
  • A proven ability to identify innovative regulatory solutions to support the advancement of complex biologic products.

  • Vice President Regulatory Affairs

    2 weeks ago

    boston, United States Albion Rye Associates Full time

    Company Overview:Join a cutting-edge biotechnology company in Boston, committed to pioneering breakthrough therapies that address unmet medical needs. Our team is passionate about translating science into therapeutic solutions, and we are looking for a highly experienced Vice President of Regulatory Affairs to lead our regulatory strategy and guide us...

  • Vice President Regulatory Affairs

    2 weeks ago

    boston, United States Albion Rye Associates Full time

    Company Overview:Join a cutting-edge biotechnology company in Boston, committed to pioneering breakthrough therapies that address unmet medical needs. Our team is passionate about translating science into therapeutic solutions, and we are looking for a highly experienced Vice President of Regulatory Affairs to lead our regulatory strategy and guide us...

  • Executive Director of Regulatory Affairs

    2 days ago

    Boston, United States Trebla Talent Full time

    RoleExecutive Director/ Vice President of Regulatory Affairs Bay Area – HybridCompany DescriptionThis pre-IPO, clinical-stage biotech focuses on developing novel immunotherapies, particularly (NK) cells and T cell engagement, to treat cancer and autoimmune diseases. They are looking for someone with BLA experience in Hem-Onc! Role DescriptionWorking...

  • Executive Director of Regulatory Affairs

    2 days ago

    Boston, United States Trebla Talent Full time

    RoleExecutive Director/ Vice President of Regulatory Affairs Bay Area – HybridCompany DescriptionThis pre-IPO, clinical-stage biotech focuses on developing novel immunotherapies, particularly (NK) cells and T cell engagement, to treat cancer and autoimmune diseases. They are looking for someone with BLA experience in Hem-Onc! Role DescriptionWorking...

  • Fiscal Affairs Associate Vice President

    4 weeks ago

    Boston, Massachusetts, United States Mass Inc Full time

    Job Description:Massachusetts College of Art and Design seeks a highly skilled and experienced Associate Vice President for Fiscal Affairs to join its team. Reporting to the Vice President of Administration & Finance, this key role is responsible for the planning, operation, direction, and supervision of all financial and administrative operations, including...

  • Associate Vice President for Fiscal Affairs

    4 weeks ago

    Boston, Massachusetts, United States Mass Inc Full time

    Job Description:Massachusetts College of Art and Design seeks a highly skilled and experienced Associate Vice President for Fiscal Affairs to join its team. Reporting to the Vice President of Administration & Finance, this key role will oversee the planning, operation, direction, and supervision of all financial and administrative operations, including...

  • Vice President of Regulatory Affairs

    3 weeks ago

    Boston, United States Jacobs Management Group Full time

    Are you ready to make a meaningful impact in the world of biotech? My client is a pioneering company at the forefront of developing autologous stem cell therapies for neurodegenerative disorders such as ALS, MS, and Parkinson’s disease. These life-altering diseases represent unmet medical needs, and they are committed to advancing innovative therapies to...

  • Trebla Talent | Executive Director of Regulatory Affairs | boston, ma

    2 days ago

    boston, United States Trebla Talent Full time

    RoleExecutive Director/ Vice President of Regulatory Affairs Bay Area – HybridCompany DescriptionThis pre-IPO, clinical-stage biotech focuses on developing novel immunotherapies, particularly (NK) cells and T cell engagement, to treat cancer and autoimmune diseases. They are looking for someone with BLA experience in Hem-Onc! Role DescriptionWorking...

  • Trebla Talent | Executive Director of Regulatory Affairs | boston, ma

    3 hours ago

    boston, United States Trebla Talent Full time

    RoleExecutive Director/ Vice President of Regulatory Affairs Bay Area – HybridCompany DescriptionThis pre-IPO, clinical-stage biotech focuses on developing novel immunotherapies, particularly (NK) cells and T cell engagement, to treat cancer and autoimmune diseases. They are looking for someone with BLA experience in Hem-Onc! Role DescriptionWorking...

  • Assistant Vice President of Equity and Access

    2 weeks ago

    Boston, United States University of Massachusetts Full time

    Job no: 525362 Position Type: Staff Full Time Campus: UMass President's Office Campus Location: Beacon Street-BostonDepartment: Academic AffairsDate opened: Oct 15 2024 Eastern Daylight TimeApplications close:Assistant Vice President of Equity and AccessThe University of Massachusetts System seeks an inspiring, collaborative, and solution-oriented...

  • Associate Vice President for Fiscal Affairs

    4 weeks ago

    Boston, Massachusetts, United States Mass Inc Full time

    Job Description:Mass Inc is seeking a highly skilled and experienced Associate Vice President for Fiscal Affairs to join our team. The successful candidate will be responsible for the planning, operation, direction, and supervision of all of the College's financial and administrative operations, including oversight of relationships and management of...

  • Sr. Director, Global Regulatory Affairs

    3 weeks ago

    Boston, United States Aveo Pharmaceuticals Inc Full time

    JOB TITLE: Sr. Director, Global Regulatory Affairs REPORTS: Vice President, Regulatory Affairs DEPARTMENT: Regulatory Affairs DATE PREPARED: October 17, 2024JOB SUMMARY: AVEO Oncology is seeking an experienced Senior Director, Regulatory Affairs who will develop and execute global regulatory strategies in support of the development for assigned programs...

  • Executive Vice President of Internal Operations

    4 weeks ago

    Boston, Massachusetts, United States Sattler College Full time

    Job DescriptionAs the inaugural Executive Vice President at Sattler College, you will partner with the President to manage the college's internal operations, while the President focuses on cultivating external partnerships, expanding support networks, and enhancing recruitment channels. In your role as EVP, you will support the President closely, assist with...

  • Director, Global Regulatory Affairs Liaison, Principal Scientist

    2 weeks ago

    Boston, United States Merck Full time

    Job Description We are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help advance our pipeline and drive our strategic priorities. The Director, Principal Scientist | Regulatory Affairs Liaison is responsible for development and implementation of worldwide regulatory strategy...

  • Vice President for Academic Affairs/Chief Academic Officer

    2 months ago

    Boston, United States Emmanuel College Full time

    Location: Boston, MA Category: Management/ Executive Posted On: Fri Jul 19 2024 Job Description: Emmanuel College seeks a visionary academic leader to serve as the Vice President for Academic Affairs/Chief Academic Officer (VPAA/CAO). The VPAA/CAO will provide strategic leadership and direction of the undergraduate and graduate programs to create the vision...

  • Assistant Vice President of Equity and Access

    2 weeks ago

    Boston, United States University of Massachusetts Full time

    The University of Massachusetts System seeks an inspiring, collaborative, and solution-oriented leader to serve as its inaugural Assistant Vice President of Equity and Access (AVP). Reporting to the Senior Vice President & Deputy Vice President for Academic Affairs, Student Affairs, and Equity, the AVP will serve as the System’s primary advisor on all...

  • Sr. Director, Global Regulatory Affairs

    3 weeks ago

    Boston, MA, United States AVEO Pharmaceuticals Full time

    JOB TITLE: Sr. Director, Global Regulatory Affairs REPORTS: Vice President, Regulatory Affairs DEPARTMENT: Regulatory Affairs DATE PREPARED: October 17, 2024 JOB SUMMARY: AVEO Oncology is seeking an experienced Senior Director, Regulatory Affairs who will develop and execute global regulatory strategies in support of the development for assigned...

  • Director, Regulatory Affairs

    3 weeks ago

    Boston, United States Meet Full time

    Director of Regulatory Affairs (CRO)Remote Opportunity - Candidates must be based in CST or ESTMeet has partnered with a mid-sized CRO that is looking for a Director of Regulatory Affairs to join their team. This candidate will be overseeing all Regulatory Strategy projects for the organization across a wide variety of therapeutic areas and modalities. Key...

  • Director, Regulatory Affairs

    2 weeks ago

    Boston, United States Meet Full time

    Director of Regulatory Affairs (CRO)Remote Opportunity - Candidates must be based in CST or ESTMeet has partnered with a mid-sized CRO that is looking for a Director of Regulatory Affairs to join their team. This candidate will be overseeing all Regulatory Strategy projects for the organization across a wide variety of therapeutic areas and modalities. Key...

  • Director, Regulatory Affairs

    4 weeks ago

    Boston, United States Meet Full time

    Director of Regulatory Affairs (CRO)Remote Opportunity - Candidates must be based in CST or ESTMeet has partnered with a mid-sized CRO that is looking for a Director of Regulatory Affairs to join their team. This candidate will be overseeing all Regulatory Strategy projects for the organization across a wide variety of therapeutic areas and modalities. Key...