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Manager Of Regulatory Affairs
A leading supplier of specialty and generic liquid pharmaceutical products.
Responsible for all activities of the Regulatory Affairs Department. Main objectives are to file and obtain ANDA approvals and to ensure compliance with FDA regulations.
- Submits quality submissions of ANDAs, AADAs, Supplements and Amendments in a timely manner.
- Reviews and submits Annual Reports, Periodic Reports, Annual Drug Reviews, Adverse Drug Experiences and Recall Coordination Activities.
- Contact person with Project Managers at FDA-CDER.
- Participates in product review meetings, evaluates project priorities and coordinates activities to facilitate timely procurement, compilation, review and submission of ANDA’s and Supplements; Monitors review and approvals.
- Interfaces with QC/QA, R&D, Marketing and Manufacturing in data generation and strategy development.
- Provides regulatory/technical input for product development and reformulation.
- Interprets regulations and provides consultancy for compliance needs.
- Provides answers to Marketing inquiries.
- Supervises staff and assists in their professional development, performance evaluation and salary administration.
- Prepare and review documents for INDs, NDAs, and DMFs
- Review and submit protocol changes and safety reports for clinical studies
- Coordinate and process documents for registration
- Review drug advertisements / promotions
- Write and revise SOP’s related to labeling, recalls, and other issues
- Manage change control system for drug products
- Manage submission of annual reports, drug listings, and supplements
- Generate and coordinate documents for ANDA submissions
- Organize doocuments for pre-approval inspection
- Review and submit materials to the FDA
- Strategy with the FDA
- Strategy with the Department and other departments
- Respond to deficiencies
- Negotiate with FDA on all issues
- Advanced degree in a scientific/technical discipline
- Five to seven years of pharmaceutical industry experience and a minimum of three to five years FDA submission experience.