The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
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.
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%).
Telecommuting is allowed.
Internal Number: 1235
About CIVICA INC
We are creating a public asset whose mission is to ensure that essential generic medications are accessible and affordable. Join us in our mission to ensure that essential generic medications are accessible and affordable.