Director Regulatory Affairs

2 weeks ago


philadelphia, United States EPM Scientific Full time

Director of Regulatory Affairs Strategy

This position is with a rapidly growing pharmaceutical company known for its commitment to advancing transformative therapies. In this role you will have a unique opportunity to lead regulatory strategies for innovative pharmaceutical products, making a meaningful impact on patient health. You'll collaborate with cross-functional teams and engage directly with regulatory agencies, influencing critical decisions in drug development.



Key Responsibilities:

  • Oversee daily regulatory activities for projects involving compounds in development or on the market, including submission strategies and regulatory intelligence.
  • Collaborate with Project Teams to develop regulatory and product strategies, including drafting labeling and NDA package inserts.
  • Work with various departments to formulate and execute effective Regulatory Strategies, assessing and communicating regulatory risks and opportunities.
  • Manage submissions and maintenance of INDs, NDAs, MAAs, and related documents.
  • Support due diligence activities for potential product acquisitions or partnerships.
  • Serve as the primary regulatory contact with agencies, including the FDA, and represent the regulatory function in key meetings.
  • Monitor the regulatory landscape and communicate updates to stakeholders.
  • Advise on regulatory requirements to support business strategies, providing expert guidance on scientific and medical issues.



Qualifications:

  • Bachelor's degree in life sciences or related field; advanced degree preferred.
  • Minimum 10 years of experience in pharmaceutical regulatory drug development.
  • Proven track record in new chemical entity and line extension filings.
  • Experience interacting with global health authorities and conducting due diligence.
  • Strong knowledge of global pharmaceutical regulations and excellent communication skills.



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