Job Order: 6077
Staff Representative: Tim Jadwin
Position: Manager Of Regulatory Affairs
Location: Illinois
Company Summary:
A leading supplier of specialty and generic liquid pharmaceutical products.
Description:
Responsibilities:
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.
Typical Duties:
- 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
Job Specifications:
- 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.
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