Director - US RA CMC Team Leader & Innovation, Global CMC Regulatory Affairs
New
J
JobgetherVeterinary pharmaceuticals
Fully remote position based in the United States.Full-TimeDirector
Salary180,000 - 230,000 USD per year
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Job Details
- Experience
- Significant industry experience in CMC Regulatory Affairs, including substantial responsibility for US regulatory submissions, product development, and lifecycle management.
- Required Skills
- Project Management
Requirements
- Bachelor's, master's, or doctoral degree in a relevant scientific discipline such as Biology, Biochemistry, Chemistry, Bioengineering, or a related field.
- Significant industry experience in CMC Regulatory Affairs, including substantial responsibility for US regulatory submissions, product development, and lifecycle management.
- Strong knowledge of US CMC regulations, regulatory guidance, FDA requirements, and health authority expectations.
- Experience developing regulatory strategies for pharmaceutical products, including post-approval changes, manufacturing changes, compliance activities, and lifecycle initiatives.
- Experience planning, preparing, reviewing, and coordinating regulatory submissions and responses to health authority questions.
- Experience with global CMC regulatory requirements and exposure to regulatory authorities across international markets.
- Ability to provide strategic, risk-based advice on complex CMC matters and translate requirements into practical recommendations.
- Experience leading, mentoring, or developing regulatory professionals and coordinating complex cross-functional initiatives.
- Understanding of manufacturing operations, technology transfers, product and process improvements, and regulatory implications of supply chain and site changes.
- Strong organizational and project management skills, including managing competing priorities in a global environment.
- An advanced scientific degree is an advantage.
Responsibilities
- Lead the US Regulatory Affairs CMC team, setting priorities and guiding performance.
- Develop and implement US CMC regulatory strategies across product development, registration, commercialization, and post-approval lifecycle management.
- Oversee preparation, review, and submission of CMC documentation, applications, amendments, supplements, and responses to health authority questions.
- Oversee ongoing CMC compliance and management of product and manufacturing changes.
- Support technology transfers, site strategy, manufacturing changes, product and process improvements, and supply chain optimization.
- Lead global CMC regulatory innovation strategies for small-molecule products, including for FDA, EMA, and other relevant authorities.
- Partner with global regulatory colleagues and cross-functional teams to align regulatory plans with project and business objectives.
- Advise project teams on regulatory requirements, risks, opportunities, and complex CMC issues.
- Represent the organization in US health authority interactions and monitor evolving US CMC regulations and guidance.
- Improve regulatory processes, tools, and operating practices, and coach and develop regulatory professionals.
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