Senior Manager role in regulatory affairs focused on chemistry, manufacturing, and controls (CMC) for medicinal products, medical devices, and related categories. Responsibilities include client relationship management, regulatory documentation preparation, project oversight, and team leadership across human and veterinary product portfolios.

Responsibilities

Develop and maintain client relationships; drive service opportunities and identify cross-selling prospects
Prepare, review, and compile CMC regulatory documentation for product applications, renewals, and variations
Lead project teams to deliver within budget; coordinate with internal and external partners
Represent clients in communications with health authorities and scientific advice procedures
Mentor colleagues on CMC services; maintain and share regulatory intelligence across organization

Requirements

Bachelor's degree in life sciences, pharmacy, biomedical sciences, public health, or related field
10+ years experience in scientific consulting, healthcare, or life sciences sector
2+ years in management capacity
Demonstrated ability to lead and mentor staff; strong project management skills
Advanced written and verbal communication in English; local language proficiency preferred
Strategic planning capability and client relationship management at senior level
Certification in regulatory affairs, clinical research, or health economics preferred

Senior Manager (Level 1), Regulatory Affairs CMC

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