Manager, Regulatory Affairs CMC

Employment Type

: Full-Time


: Miscellaneous

Our Regulatory Affairs team brings essential generic quality medicines to our hospital members in the United States by providing CMC Regulatory leadership and establishing Civica’s Regulatory Affairs systems and processes. The Manager, Regulatory Affairs CMC:

  • Provides CMC regulatory support for development programs and marketed products.
  • Develops product CMC regulatory strategy for essential generic medicines and obtains shortest time to approval by regulatory agencies.
  • Prepares and compiles new ANDAs, Amendments, Supplements, Annual Reports, and other regulatory filings ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met.
  • Critically reviews documentation intended for submission to the FDA for internal consistency, for consistency to relevant FDA guidelines and to promote regulatory excellence.
  • Represents Civica with external organizations through direct communication with the FDA, including telephone calls and e-mail; participates in meetings between company and FDA, as assigned.
  • Responsibilities to include but not limited to:

  • Performs final quality check of electronic regulatory submissions.
  • Identifies and leads process for obtaining feedback from key stakeholders for continuous improvement.
  • Stays updated on agency’s expectations based on guidance documents and deficiencies and applies the same logic for future submissions to avoid any similar deficiencies.
  • Support change management activities.
  • Assists with other Regulatory Affairs department functions as needed, including labeling/artwork management and Office of Prescription Drug Promotion (OPDP) submissions.
  • Education Minimum Requirement

    B.S. in a biological or life science, engineering, or a related field (advanced degree preferred). Fields of study include Biology, Microbiology, Virology, Molecular Biology, Chemical Engineering, or Biochemistry.

    Required Experience

    At least five (5) years of relevant experience, including CMC development; manufacturing, testing, or licensure of generic pharmaceutical products; or related fields. Focus in regulatory strategy and generic submissions highly preferred. Experience in the manufacture of sterile injectable pharmaceutical products and/or drug-device combination products a plus. The candidate must be proficient in English; additional language skills are a plus. The candidate may be required to travel on a periodic basis (approximately 10%).

    Relocation or remote work may be offered to the right candidate.

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