Regulatory Affairs Manager - Katalyst Healthcares & Life Sciences
Menlo Park, CA 94025
About the Job
Responsibilities:
- Manages most aspects of company regulatory interface with domestic and international health authorities.
- Manages the development and deployment of the regulatory program that ensures aggressive product approval.
- Manages and may generate regulatory submission documents for new products or changes to existing health authorities' filings, including domestic and international submissions and registration.
- Manages the submissions of clinical study submissions.
- Determines governmental regulations affecting company processes and assures the processes are complete and accurate to ensure company compliance.
- Partners with various teams throughout organization (Clinical Operations, R&D, Quality, etc.) on projects.
- Works with clinical team to assure appropriate organization and data are used for regulatory submissions and clinical presentations.
- Provides guidance with localization and labeling requirements.
- Manages regulatory reporting.
- Bachelor's or advanced degree preferred (M.S., Pharm.D., M.D., Ph.D.) in a scientific discipline.
- 5 + years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries.
- Strong analytical and problem-solving skills.
- Strong written and verbal communication skills, including the ability to interact effectively and to influence.
Source : Katalyst Healthcares & Life Sciences
