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Regulatory Affairs Director

1 month ago

Basking Ridge, New Jersey, United States BioSpace, Inc. Full time
Job Title: Regulatory Affairs Director

The Director of Regulatory Affairs will provide leadership on global regulatory activities for assigned products. Responsibilities will focus on Clinical Regulatory filings and provide regulatory leadership on project teams in this area. We are a hands-on culture, so responsibilities will include support to some clinical study activities. The candidate will also supply, lead, and/or supervise IND/CTA and BLA submissions activities.

Key Responsibilities:
  • Provide interpretation of regulatory authorities' feedback, policies, and guidelines.
  • Lead the development of regulatory strategic plans either directly or in conjunction with project teams.
  • Work with project teams to resolve complex project issues.
  • Responsible for quality and timeliness of IND/CTA and BLA submissions.
  • Interact with other functions and partners in the preparation, review, and completion of documents for regulatory submissions.
  • Provide interpersonal support and lead personnel.
Requirements:
  • Strong understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices.
  • Ability to interact with CROs in the management of ex-US/ex-EU CTAs towards clinical trial activations.
  • High attention to detail; ability to coordinate and prioritize assigned projects according to company goals.
  • Strong interpersonal skills, both written and verbally.
Education and Experience:
  • MD, Ph.D., or Pharm D. degree.
  • Minimum of 10 years of pharmaceutical industry experience, at least 7 of which should include regulatory experience.
Work Environment:

This role requires working onsite 3 days per week in either Basking Ridge, NJ, Armonk, NY, or Tarrytown, NY.