We are currently working on a Regulatory Affairs Manager/Sr. Manager position in the Southern California responsible for the preparation, coordination and assessment of CMC documents for regulatory submissions to U.S. and International regulatory agencies. Our client is one of the 500 fastest growing technology companies North American and they have an excellent pipeline causing the need for growth within their regulatory team. They offer excellent pay, benefits and team culture where employees have the opportunity to take on more responsibility and grow with the company.
Desired Experience:
– B.S. in Chemistry, Biology, Biological Science or related.
– At least 4+ years of Hands-on experience in biologic CMC Regulatory Affairs. Proficient knowledge in U.S. and EU biologics regulations and guidelines needed.
– Experience in writing regulatory CMC modules for biologics in early and late-phase development, and annual reports, with experience in preparing BLAs is preferred.
– Must be experienced in the timely preparation and delivery of high-quality CMC modules for regulatory submissions.
– Must be located in the Southern California area or open to relocation to the area.
Please contact us to learn more!
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