Director Global Regulatory CMC
Director Global Regulatory CMC
A leading biopharmaceutical organization is seeking an experienced Regulatory Affairs CMC leader to provide strategic regulatory support across development and commercial programs. This individual will be responsible for shaping and executing global CMC regulatory strategies for complex pharmaceutical products throughout the product lifecycle, from early development through registration and post-approval activities.
The successful candidate will serve as a key regulatory partner to cross-functional teams and provide strategic guidance to support successful interactions with global health authorities.
Key Responsibilities
- Develop and execute global CMC regulatory strategies for investigational, registration, and post-approval activities across assigned programs.
- Lead CMC regulatory components of major global submissions, including INDs, CTAs, NDAs, BLAs, MAAs, lifecycle management filings, and related variations.
- Provide strategic regulatory guidance throughout product development, registration, launch, and post-market phases.
- Represent Regulatory Affairs in cross-functional project teams, collaborating closely with development, manufacturing, quality, and commercial stakeholders.
- Lead preparation for and participate in interactions with global health authorities regarding CMC-related topics.
- Review and provide regulatory input on technical documents, protocols, reports, manufacturing changes, and quality-related activities.
- Identify regulatory risks and drive mitigation strategies to support successful development and commercialization outcomes.
- Ensure regulatory submissions and supporting documentation align with current regional and global requirements.
- Maintain regulatory strategy documents, risk assessments, and other key project deliverables.
- Monitor evolving regulatory expectations and apply regulatory intelligence to inform business decisions and development strategies.
- Support organizational initiatives, process improvements, training activities, and best practice development within the regulatory function.
- Mentor and support junior regulatory professionals as appropriate.
Qualifications
- Advanced degree (MS, PhD, PharmD, or equivalent) in a scientific discipline required.
- 10+ years of experience within the biopharmaceutical or biotechnology industry.
- At least 8 years of direct Regulatory Affairs CMC experience supporting development and commercial products.
- Demonstrated success leading CMC regulatory strategy and major global submissions, including NDA, BLA, MAA, or equivalent applications.
- Strong understanding of pharmaceutical development, manufacturing, analytical sciences, quality systems, and global CMC regulatory requirements.
- Experience supporting products across multiple stages of development and lifecycle management activities.
- Proven ability to communicate complex regulatory strategies to technical and non-technical stakeholders.
- Experience interacting with major global health authorities and managing regulatory negotiations.
- Strong analytical, problem-solving, and risk assessment skills.
- Ability to influence cross-functional teams and operate effectively within a matrix organization.
- Excellent written, verbal, and interpersonal communication skills.
- Demonstrated leadership, sound judgment, and ability to manage critical issues independently.
- Monthly onsite requirement
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