Associate Director, Regulatory Affairs
- Represent Regulatory Affairs on global project teams, subteams and in joint alliances as required. Direct all aspects of regulatory support and strategy for the global project team on the designated product(s).
- Apply a comprehensive understanding of global regulations and guidelines for oncology projects to enhance probability of regulatory success and regulatory compliance
- Independently defines content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirements
- Lead the preparation of regulatory submissions including INDs, CTAs, annual reports, and, briefing packages
- Ensure the project team objectives and timelines are supported by regulatory deliverables.
- Keep abreast of all pertinent laws, regulations and guidance relevant to oncology and the specific product areas.
- Provide expertise in the interpretation of regulations and guidance relating to product development.
- Fosters constructive working relationships when interacting with internal and/or external colleagues
EDUCATION AND EXPERIENCE:
- BS/BA Degree in a Scientific Discipline
- 8+ years pharmaceutical Regulatory experience.
- Broad understanding of drug development and oncology
- Competency in FDA regulatory requirements is essential. Global experience is a plus
- Excellent verbal and written skills
- Flexible mindset and ability to multitask
- Demonstrates leadership, problem-solving ability, flexibility and teamwork
- Exercises good judgement in elevating and communicating actual or potential issues to line management.
CONTACT: Please submit the form below: