This client is a leader in women’s healthcare products including oral and emergency contraceptives. They are seeking a Regulatory Affairs Associate Director or Director who can develop and execute regulatory strategies for programs in development and support approved products. You will lead work directly with health authorities and lead FDA filings. This company offers competitive compensation, great employee benefits, and a patient-focused culture. Now is an exciting time to join this growing organization and help to get new reproductive healthcare products approved!
Responsibilities:
- Lead regulatory activities for the development and execution of clinical, non-clinical, and commercial regulatory efforts for a portfolio of reproductive and other healthcare products.
- Oversee regulatory filings (IND, NDA, ANDA, etc.) including authorship of critical documents as needed.
- Manage all operational aspects of preparing compliant submissions to Regulatory Agencies.
- Serve as primary interface with FDA and various other competent authorities.
- Lead the preparation of FDA meeting documents, meeting requests, meeting packages, etc.
- Manage regulatory submission timelines in accordance with project plans.
- Support maintenance and regulatory compliance of existing products in the US.
- Provide regulatory expertise and policy support for good pharmaceutical development practices (GCPs, GMPs and GLPs)
- Support product labeling and safety assurance to obtain FDA approval and support for products.
- Conduct regulatory intelligence and monitor the impact of new government regulatory activities.
- Serve as a resourceful and collaborative team member to help inform strategic decisions.
Required Background:
- Bachelor degree in a scientific field required. Advanced degree preferred.
- Seven or more years of experience in Regulatory Affairs for pharmaceutical drugs.
- Prior experience with clinical regulatory strategy for programs in development along with post-approval regulatory activities for life cycle management
- Successful track record of filing of INDs, NDAs, sNDAs, briefing packages, and various other important regulatory documents.
- Direct experience interacting with FDA and/or other health authorities.
- Strong working knowledge of electronic document and submission standards and requirements applicable to the US regulatory environment.
- Experienced in eCTD publishing.
- Must be comfortable working on reproductive health programs.
- Detail oriented with excellent oral and written communication skills, including proficiency in scientific writing, and experience interfacing with management.
- Strong organizational skills and ability to maintain a high level of communication, productivity, innovation, and priority‐setting to meet aggressive timelines.
- Self‐motivated, self‐disciplined, and able to function independently as well as part of a team.
- Must be comfortable working for a small organization, and able to handle ambiguity and change.