Director, Pharmacovigilance Regulatory Affairs

7 days ago

Cambridge, United States The Steely Group Full time

Our client is looking to add a Director of PV Regulatory leader to its team on a permanent basis. Reporting to the PV Division Director at company headquarters in Japan, this is a hybrid role expected to be in the Cambridge, MA office 3 days per week.


Responsibilities:

  • Promote proper use by conducting necessary internal and external communication such as consultation with the regulatory authority so that safety assurance measures planned based on the risk/benefit evaluation of each product can be appropriately implemented based on the developed PV plan.
  • Draw up budget plans necessary for the implementation of operations as PV Regulatory, confirm that these plans have been appropriately implemented, and modify the plans as necessary.
  • Prepare the “package insert (draft)” for the approval application/coordinate to revise package insert in post-marketing phase when necessary and submit and disclose the package insert approved by the regulatory authority.
  • Negotiates and coordinates with the regulatory authorities in pharmacovigilance activities as the primary contact and gives advice on materials to be submitted to the regulatory authorities.
  • Collect and analyze information on local regulatory requirements, policies and guidelines related to PV activities, promptly notify any information with potential local and global impact and support reflecting it to procedures appropriately.
  • In preparation for global expansion, cooperate formulating G-SOPs and SOPs, and establishing a global safety management system.
  • Establish and maintain a system to share and advise on domestic regulatory information related to pharmacovigilance activities (regulatory intelligence).
  • Develop human resources for appropriate business operations and enhance organizational capabilities by improving the problem-solving skills and mutual assistance system as a section.
  • Involve internal and external stakeholders (Including departments, related departments, headquarters, partner companies) to proactively implement the PDCA for pharmacovigilance activities.


Requirements / Qualifications:

  • Bachelor of Science (B.S.) degree from an accredited educational institution, or the equivalent in experience required. A Master of Science (M.S.), Doctorate of Pharmacy (Pharm.D.), or Doctorate of Philosophy (Ph.D.) degree in the life or physical sciences is preferred.
  • Ten (10) years of regulatory experience for small molecules and biologics within the pharmaceutical or biotechnology industry, along with demonstrated success as a PV, Regulatory Affairs organizational leader, able to lead, direct and develop member of the PV regulatory function. Knowledge and experience in US and EU regulations, PMDA, ICH guidelines, and understanding of Individual Case Safety Reports (ICSR), safety database and safety gateway are required.
  • Significant work experience and management experience in the PV, Regulatory Affairs department of an established United States-based pharmaceutical company, having worked directly with the Food and Drug Administration (FDA) to successfully obtain drug approval is required for this position. Although the scope of responsibility for this position is primarily domestic (United States, it is preferred that the incumbent possess knowledge and experience in European and Japanese PV, Regulatory Affairs.)
  • Thorough understanding of all aspects of pharmaceutical product development and regulatory requirements.
  • Strategic thinker, able to create and implement short- and long-term plans, identifying and utilizing the necessary resources for meeting all pre-determined timelines and outcomes
  • Ability to communicate with internal and external stakeholders (level at which safety management information, safety measures, etc. can be discussed)
  • Work is generally sedentary in nature, but may require standing, walking, grasping, to maintain a neat and organized work environment.
  • The noise level in the work environment is usually quiet.
  • This role requires the incumbent to travel (domestic and/or international) based upon the needs of the business, up to 30% of the time.

  • Director, Pharmacovigilance Regulatory Affairs

    7 days ago

    Cambridge, United States The Steely Group Full time

    Our client is looking to add a Director of PV Regulatory leader to its team on a permanent basis. Reporting to the PV Division Director at company headquarters in Japan, this is a hybrid role expected to be in the Cambridge, MA office 3 days per week.Responsibilities:Promote proper use by conducting necessary internal and external communication such as...

  • Senior Director, Pharmacovigilance

    15 hours ago

    Cambridge, United States Nimbus Therapeutics Full time

    Nimbus has an outstanding opportunity for an exceptional Senior Director of Pharmacovigilance to join our team.  This physician leader shall have strategic and hands-on responsibility for clinical drug safety, particular within the therapeutic area of Oncology. Broad drug safety experience with small organic molecules is required to ensure monitoring,...

  • Vice President, Head of Safety

    1 month ago

    Cambridge, United States Astria Therapeutics Inc Full time

    **Position Overview**: Astria is seeking an innovative and collaborative individual who will play a pivotal role in fostering a culture of safety within the company ensuring that Astria remains at the forefront of patient safety and pharmacovigilance. The individual will be responsible for the strategic implementation, execution, and management of...

  • Associate Director, Regulatory Affairs

    4 weeks ago

    Cambridge, United States Bicycle Therapeutics Full time

    Job DescriptionThe Associate Director of Regulatory Affairs will be responsible for the development and execution of regulatory strategy for assigned BicycleTx programs or projects.The Associate Director Regulatory Affairs will be responsible for oversight of the operational execution of Regulatory submissions for their assigned BicycleTx programs or...

  • Associate Director, Regulatory Affairs

    3 weeks ago

    Cambridge, United States Vertex Ventures HC Full time

    Bicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This...

  • Associate Director, Regulatory Affairs

    4 weeks ago

    Cambridge, United States Bicycle Therapeutics Full time

    **Company Description** Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Cambridge, MA. **Culture** is key and all Bicycle employees actively embrace and role model our company values: - We are **Adventurous**. We believe it’s the way to deliver extraordinary results for our...

  • Director, PV Regulatory

    1 month ago

    Cambridge, United States ONO PHARMA USA Full time

    To promote proper use by conducting necessary internal and external communication such as consultation with the domestic regulatory authority so that safety measures planned based on the risk/benefit evaluation of each product can be appropriately implemented based on the developed PV plan.To develop human resources for appropriate business operations and...

  • Director, PV Regulatory

    4 weeks ago

    Cambridge, United States ONO PHARMA USA Full time

    To promote proper use by conducting necessary internal and external communication such as consultation with the domestic regulatory authority so that safety measures planned based on the risk/benefit evaluation of each product can be appropriately implemented based on the developed PV plan.To develop human resources for appropriate business operations and...

  • Director, PV Regulatory

    4 weeks ago

    Cambridge, United States ONO PHARMA USA Full time

    To promote proper use by conducting necessary internal and external communication such as consultation with the domestic regulatory authority so that safety measures planned based on the risk/benefit evaluation of each product can be appropriately implemented based on the developed PV plan.To develop human resources for appropriate business operations and...

  • Associate Director, Pharmacovigilance Operations

    1 week ago

    Cambridge, United States Nuvalent, Inc. Full time

    **The Company**: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and...

  • Associate Director, Regulatory Affairs

    4 weeks ago

    Cambridge, United States Bicycle Therapeutics Full time

    Job DescriptionJob DescriptionCompany DescriptionBicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two...

  • Associate Director, Regulatory Affairs

    1 week ago

    Cambridge, United States Bicycle Therapeutics Full time

    Bicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry....

  • Associate Director, Regulatory Affairs

    2 weeks ago

    Cambridge, United States Bicycle Therapeutics Full time

    Bicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry....

  • Medical Director, Safety

    15 hours ago

    Cambridge, United States Scholar Rock Full time

    Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the...

  • Lead Regulatory Affairs Director

    3 weeks ago

    Cambridge, United States Aspartes Pharmaceuticals Full time

    **Position Overview**: We are seeking an exceptionally talented lead Regulatory Affairs director with a high level of experience in the rare/ultra-rare disease space. The role is centered around providing key insight and regulatory input for the development of a small molecule treatment for a rare-pediatric CNS disorder on the US...

  • Associate Director of Regulatory Affairs

    1 week ago

    Cambridge, United States PSG Global Solutions Full time

    Description We're looking for an Associate Director of Regulatory Affairs, working in Pharmaceuticals and Medical Products industry in Cambridge, Massachusetts, United States. Works proactively in a cross-functional organization to partner with various other expertise areas and regional regulatory partners (as applicable) to plan and execute global...

  • Director, Pharmacovigilance Operations

    4 weeks ago

    Cambridge, Massachusetts, United States Sana Biotechnology Full time

    About the role Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who want to challenge status quo, and who lead with the desire to work on novel ideas. As the Director, Pharmacovigilance Operations you will report to the Head of PV and Safety and be involved in all related...

  • Director, Pharmacovigilance Operations

    2 months ago

    Cambridge, Massachusetts, United States Sana Biotechnology Full time

    About the role Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who want to challenge status quo, and who lead with the desire to work on novel ideas. As the Director, Pharmacovigilance Operations you will report to the Head of PV and Safety and be involved in all related...

  • Associate Director, Regulatory Affairs CMC

    2 weeks ago

    Cambridge, Massachusetts, United States Voyager Therapeutics, Inc. Full time

    The Associate Director of Regulatory Affairs CMC will be responsible for developing, implementing and advising on global Regulatory CMC strategies for new and late stage programs to secure approval of the manufacturing process and control testing for initial clinical trials under INDs/CTAs and transition to appropriate GMP validation to move expeditiously in...

  • Senior Director Regulatory Affairs

    4 weeks ago

    Cambridge, United States RBW Consulting Full time

    RBW is partnering with an innovative late clinical-stage, oncology Biotech (140 FTE) in their urgent and business-critical search for a new Senior Director, Regulatory Affairs. Our client is focused on discovering and developing precision medicines for the treatment of autoimmune and inflammatory diseases.The candidate will report directly to the SVP of RA,...