More jobs:
Senior Regulatory Affairs Associate, CMC
Job in
Santa Monica, Los Angeles County, California, 90403, USA
Listed on 2026-07-13
Listing for:
Jobtailor
Full Time
position Listed on 2026-07-13
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist -
Pharmaceutical
Regulatory Compliance Specialist
Job Description & How to Apply Below
- Responsible for preparing moderately complex regulatory submissions requiring interactions with departments outside of Regulatory Affairs CMC for investigational and commercial products
- Supports operational and life cycle management of regulatory CMC submissions in support of global commercial and clinical programs
- Identify CMC risk areas and suggest alternative scenarios and course of action
- Act as Regulatory CMC representative on cross-functional project teams
- Ensure that CMC-specific registered technical details are updated and maintained
- Manage Regulatory CMC commitments made to Health Authorities
- Support Annual Product Review or Vector Product Review for all products
- Present project status updates and strategic approaches to moderately complex programs
- BA/BS degree with 5 years of relevant experience in Regulatory Affairs CMC and/or biopharmaceutical industry or 3 years of relevant experience with a master's degree
- Some knowledge of ICH requirements
- understanding of current global trends in CMC Regulatory Affairs
- Organizational skills – detail oriented and able to adapt to frequent changes in product activity
- Excellent interpersonal, verbal and written communication skills
- High energy level and a positive outlook coupled with the requisite “can do” attitude
- Self-motivated with a strong sense of ownership
- High degree of professionalism, ethics and integrity
- Comfortable in a fast-paced company environment with minimal direction
Position Requirements
10+ Years
work experience
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
Search for further Jobs Here:
×