Regulatory Affairs Manager - US
The Regulatory Affairs Manager assists in overseeing the regulatory activities supporting the clinical advancement of the product(s) to which they are assigned. This role is expected to provide support to the Regulatory Affairs Lead for regulatory activities and interactions with the FDA.
- Develop and contribute to content for regulatory submissions and related supplements and amendments, including FDA meeting requests, briefing books, INDs, orphan drug designations
- Assist in developing responses to requests from the FDA.
- Review of regulatory documents (protocols, CSRs, Module 2 documents) developed by the Medical Writing department
- Work with RA Lead and project teams regarding the development and execution of the regulatory strategy through the clinical development process of the product assigned to.
- Serve as the regulatory representative for clinical trial teams, providing US regulatory input and ensure alignment with global regulatory strategies
Skills and Requirements:
• BA/BS degree required (strong preference to be in scientific discipline), Masters or PhD preferred.
• 5+ years of experience in the Pharmaceutical industry.
• 3+ years of experience in Regulatory strategy, with experience in oncology.
• Strong knowledge of current US regulations.
• Ability to work both independently and within project teams, committees, etc to achieve group goals.
• Knowledgeable in eCTD format and regulatory filings
• Exceptional written and oral communication
• Demonstrate strong organizational skills and the ability to work within tight timeframes.
• Experience and knowledge in the preparation of major regulatory submissions (NDAs) and supportive amendments or supplements.
• Experience in interpretation of regulations, guidelines, policy statements, etc.
• Experience working on products in development specifically relating to clinical regulatory aspects of the project.