Regulatory Affairs Specialist - Katalyst Healthcares & Life Sciences
Irvine, CA 92602
About the Job
Responsibilities:
- Assist with the preparation and timely submission of New Product Applications, Annual Reports, Periodic Adverse Events Reports (PADERs), Promotional Materials (OPDP) and other post-marketing requirements to appropriate regulatory agencies (Primarily US FDA).
- Assess the appropriate regulatory reporting mechanism using FDA regulations, guidance documents, and in-house policies upon review of Change Control Documentation.
- Work closely with Regulatory Affairs, Quality Assurance, Marketing, and Product Development teams to gather information and ensure that all of regulatory documentation for new products, changes to existing products, and post-market activities are compliant.
- Review and provide guidance on product labelling, structured product labelling (SPL), promotional materials, and other product documentation to ensure compliance with regulatory requirements.
- Monitor and track regulatory submission timelines and communicate updates to relevant stakeholders.
- Bachelor's degree in Life Sciences, Regulatory Affairs, Chemistry, or a related field. Advanced degrees or certifications in Regulatory Affairs (e.g., RAC) are a plus.
- Minimum of 3 years of experience in regulatory field within the pharmaceutical, biotechnology, or medical device industry.
- Current knowledge of FDA guidelines (CFR 21).
- Development/maintenance of Regulatory trackers and databases.
Source : Katalyst Healthcares & Life Sciences
