Manager of Regulatory Affairs driving regulatory strategies for product launches and compliance. Collaborating with cross - functional teams to enhance product development and advertising campaigns.
SA
Hybrid Global Regulatory Affairs Lead – Chemistry, Manufacturing and Controls
Posted 4 minutes ago
About the role
- GRA CMC Lead driving regulatory strategies for pharmaceutical and vaccine products. Collaborating with cross-functional teams and directly influencing drug approvals through negotiations.
Responsibilities
- drive global regulatory strategies for pharmaceutical and vaccine products
- guide products from early development to market by creating smart regulatory strategies
- prepare high-quality regulatory submissions, manage compliance, and anticipate regulatory trends
- conduct risk assessments and serve as the primary liaison with regulatory authorities including FDA and EMA
- collaborate across R&D, Manufacturing, and Quality teams in strategic negotiations with health authorities worldwide
Requirements
- 6+ years of CMC regulatory experience with contributions to regulatory filings and implementation of regulatory strategies
- experience responding to Health Authority questions
- experience preparing regulatory documentation and familiarity with standard submission processes
- understanding of pharmaceutical development, manufacturing processes, and regulatory requirements in major markets
- ability to work effectively in a matrix environment, engaging cross-functionally with R&D, Manufacturing, and Quality teams
- Bachelor's degree in a scientific discipline (Chemistry, Biology, Pharmacy, or related field)
- strong written and verbal communication skills, with fluency in English
- capability to manage multiple projects in a fast-paced, hybrid work environment (60% on-site)
Benefits
- high-quality healthcare
- prevention and wellness programs
- at least 14 weeks’ gender-neutral parental leave
- thoughtful, well-crafted rewards package
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