Manager in regulatory affairs leading product registrations, CMC strategy development, and cross-functional coordination for established pharmaceutical products. Manages complex regulatory submissions, maintains compliance throughout product lifecycle, and mentors junior team members.
Responsibilities
Lead product registrations and prepare documentation packages for regulatory submissions
Develop and communicate regulatory CMC strategies for assigned products and projects
Represent regulatory position at project meetings and monitor compliance across product lifecycle
Mentor junior team members and provide training on regulatory subject matter expertise
Identify risks and coordinate with affiliates and cross-functional teams on regulatory activities
Requirements
Bachelor's degree in pharmacy, biology, chemistry, pharmacology, or related field
Minimum 10 years regulatory affairs, R&D, manufacturing, or related experience
Specialist knowledge of regional and country-specific regulatory requirements
Project management and cross-functional coordination capabilities
CMC regulatory and technical scientific principles knowledge
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