Vice President of Regulatory Affairs

4 weeks ago

Petersburg, United States Civica Rx Full time
About the Role

Civica Rx is seeking a highly experienced Vice President, Regulatory Affairs to lead our regulatory affairs efforts and ensure the compliance of our products with regulatory requirements.

The successful candidate will have a proven track record of leading global CMC regulatory strategies and have experience with leading NDA/ANDA/BLA/IND/IMPD/CTA submission and approvals.

The role will involve leading the regulatory team in the development and compilation/publishing of documentation for regulatory submissions, as well as providing regulatory leadership as needed in product in-license / due diligence review, product divestment and product withdrawal.

The ideal candidate will have a scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas, and will have demonstrated organizational leadership skills at both functional and enterprise levels.

Key Responsibilities:

  • Lead global CMC regulatory strategies for projects in development and marketed products
  • Lead the regulatory team in the development and compilation/publishing of documentation for regulatory submissions
  • Provide regulatory leadership as needed in product in-license / due diligence review, product divestment and product withdrawal
  • Exercise expertise in the interpretation and implementation of FDA guidelines
  • Ensure regulatory conformance & consistency for assigned products

Requirements:

  • Scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas
  • Demonstrated organizational leadership skills at both functional and enterprise levels
  • Experience with leading NDA/ANDA/BLA/IND/IMPD/CTA submission and approvals
  • Biologics/biosimilar and sterile injectable experience is preferable

What We Offer:

  • A flexible remote work style with travel to Civica's manufacturing facility and office as needed
  • A competitive salary and benefits package
  • The opportunity to work with a dynamic and innovative company

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