Title: Sr. Director / Director, Regulatory Affairs

Summary of Position:

The Director, Regulatory Affairs will lead development of regulatory strategy, build processes to ensure global regulatory compliance, and manage all regulatory submissions and interactions. The Director will prepare for meetings, teleconferences, and other communications with FDA and other regulatory agencies, educate teams regarding regulatory risks and implications for strategy and product development activities, and utilize technical knowledge and effectively apply regulations and guidelines to the product development process.

Summary of Essential Duties to be Performed:

  1. Lead the development of global regulatory strategy, ensuring that programs meet quality and safety standards required by patients, health care providers, and regulatory agencies.
  2. Coordinate and balance priorities of various stakeholders (corporate, scientific, clinical) in the context of regulatory requirements, through active participation in Product Development Teams.
  3. Monitor product-related corporate activities for regulatory compliance, including CMC, nonclinical, and clinical plans and practices.
  4. Provide critical review of all documentation supporting regulatory applications, including organization of regulatory file rooms and document signatures.
  5. Lead the preparation and submission of regulatory submissions to FDA and other regulatory agencies.
  6. Plan, coordinate, and prepare for meetings and teleconferences with regulatory agencies.
  7. Monitor applicable current and new regulatory requirements.
  8. Review and update regulatory processes and documentation practices to ensure company is in compliance and audit ready.
  9. Interact with company partners and consultants on regulatory matters.
  10. Contribute to the regulatory perspective on government proposals and external due diligence activities.

Summary of required/desired knowledge, skills, and other abilities or attributes:

For this role you will need

  • Advanced Degree (M.S. or Ph.D. preferred) in a Biological Science.
  • Minimum of 7 years of regulatory affairs biologics industry experience required, vaccine experience preferred.
  • Direct interaction experience with FDA required.
  • Thorough knowledge and practical application of domestic and international regulations including cGMPs, GLP, GCP and ICH.
  • Experience with submissions via eCTD (electronic gateway).
  • Excellent writing skills are required.
  • Excellent leadership, interpersonal, written and oral communication skills.