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.