Regulatory CMC Manager - Small Molecule (Contract)
$145,600–$145,600 year
RemoteUnited States
Job Summary
Execute Lifecycle Management (LCM) strategy and submissions for marketed products in international regions, focusing on small molecule programs. Plan and execute international regulatory CMC submissions, including content creation and cross-functional alignment. Review CMC sections of regulatory submissions and manage interactions with regulatory agencies. Collaborate with regulatory colleagues to develop global CMC strategies and serve as the primary regulatory CMC contact for assigned products. Provide regulatory assessment and guidance on product compliance topics, including change controls, deviations, and GMP investigations. Work Monday–Friday in EST hours as a contract role for 12 months, with potential extension.
Required Qualifications
- Strong interpersonal skills to exchange complex information with others and to guide others
- Proficiency in regulatory (FDA, EMA, ICH, international agencies) guidelines
- Strong problem-solving skills and the ability to present the overall assessment for management alignment
- Ability to collaborate and communicate in an open, clear, complete and timely manner
- Strong sense of planning and prioritization, with demonstrated results
- Bachelor's degree, with a preference in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field
- Typically requires 5 years of experience in the pharmaceutical industry or related field
- Experience supporting Small Molecule programs required
- Monday–Friday; Remote: EST hours
Desired Qualifications
- Bachelor's degree, with a preference in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field
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