Senior Director, Regulatory Affairs CMC
$258.83k - $293.48kMadrigal Pharmaceuticals
Madrigal Pharmaceuticals seeks a Senior Director of Regulatory Affairs CMC to lead strategy and execution for chemical manufacturing and controls across clinical, registration, and post-approval stages. The role requires deep expertise in small molecule regulatory development and global health authority interactions.
Responsibilities
- Independently develop and execute regulatory CMC strategies for investigational, registration, and post-approval products
- Apply expert CMC knowledge to resolve development and commercialization challenges
- Guide team in defining CMC dossier content and review for Health Authority compliance
- Represent regulatory CMC function in Health Authority meetings and drive preparation activities
- Identify regulatory CMC risks proactively, develop mitigation strategies, and communicate to management
Requirements
- BS in life sciences or healthcare field; advanced degree strongly preferred
- Minimum 15 years regulatory CMC experience with broad technical and product knowledge
- Proven track record managing small molecule clinical, commercialization, and lifecycle activities
- Demonstrated experience interacting with global Health Authorities on CMC matters
- Strong knowledge of global pharmaceutical CMC regulations, guidelines, and standards
- Excellent written and verbal communication and negotiation skills
Compensation: $258,827–$293,479 per year
Vacancy posted 25 days ago
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