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Manager, Regulatory Affairs - CMC
Los Angeles, CA
$1.00 - $2.00
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Los Angeles, CA
Currently looking for an experienced Manager, Regulatory Affairs - CMC to fill an opening with a Fortune 100 Pharmaceutical Company located in Los Angeles, CA. Interested candidates should hold a Bachelor’s Degree (Regulatory Affairs, Life Sciences, or Engineering) and have 6+ years’ regulatory and/or compliance experience.
Responsibilities of the Manager, Regulatory Affairs - CMC
Responsible for generation of the region-specific regulatory documents Clinical Trial Application and Marketing Authorization (CTAs and MAAs) and regulatory intelligence for multiple products.
Primary point of contact and interface with the Regional Regulatory Lead (RRL) and Local Regional Representative (LRR) for specific strategies or activities that impact a specific region.
Support the RA CMC Global teams with Clinical Trial initial applications, amendments, and future Marketing Application preparation.
Work within company document management system for the compilation of submission documents, tracking of submissions and approvals dates, and response to question preparation.
Facilitate product development and global registration by developing and executing regulatory strategies for product manufacturing and quality programs throughout product lifecycle.
Contribute to the development of the Regional RA CMC strategy and execute the preparation of CMC components of CTA and NDA filings for all products.
Requirements of the Manager, Regulatory Affairs - CMC
Bachelor’s Degree (Regulatory Affairs, Life Sciences, or Engineering)
6+ years’ regulatory and/or compliance experience required
MS or Doctorate preferred.
CMC-specific regulatory knowledge & experience.
Strong & effective verbal and written communication skills and ability to communicate effectively with different management levels.
Competent with Microsoft Outlook/ Word/ Excel/PowerPoint/Project.
Ability to speak and read in either Mandarin, Japanese, or Korean preferred.
Experience in manufacturing, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry.