Director, Regulatory Affairs CMC

Position Summary:

Director, Regulatory CMC. Develop and execute global regulatory CMC strategies supporting clinical development, marketing approvals, and lifecycle management worldwide across GCC, LATAM, and APAC; serve as CMC expert on cross-functional teams and guide global regulatory interactions.

Primary Responsibilities:

• Manage CMC regulatory affairs for marketed products and compounds in development per US and ex-US requirements.
• Coordinate with R&D, Pharmaceutical Development, Manufacturing, Quality, and Regulatory to develop/implement CMC regulatory strategy.
• Manage timely preparation of high-quality CMC sections of INDs, CTAs, NDAs, MAAs, and amendments for worldwide submissions.
• Serve as regulatory representative and point of contact with agencies for CMC development, product registration, and lifecycle activities.
• Provide CMC regulatory guidance and strategy to development teams, including identifying/assessing/mitigating regulatory risks.
• Ensure compliance of CMC activities with applicable regulatory requirements.
• Evaluate manufacturing processes/changes, assess regulatory implications, and support implementation.
• Maintain current knowledge of relevant guidelines/regulations and determine applicability.

Education/Experience/Skills:

• Bachelor’s degree in life science or related field (or equivalent education/experience).
• ~10 years progressively responsible CMC Regulatory Affairs experience in small-molecule drug development; 5 years in a management role.
• Knowledge of global regulatory CMC requirements/guidelines.
• Experience preparing/submitting CMC components of IND/CTA filings; regulatory briefing packages; NDA and ex-US MAA submissions.
• Cross-functional collaboration; manage competing priorities.
• Strong interpersonal skills, attention to detail, organizational skills; meet deadlines in fast-paced settings.
• Initiative, flexibility, ability to work with limited supervision; negotiate and influence senior leaders.
• Willingness/ability to travel domestically and internationally as needed.

Benefits (US-based Employees):

• Competitive base, bonus, and equity; medical/dental/vision; employer-paid life/disability/business travel/EAP; 401(k) match 1:1 up to 5%; ESPP with 2-year lock-in; 15+ vacation days; 13–15 paid holidays; 10 sick days; paid parental leave; tuition assistance.

Salary Range:

$189,700—$237,100 USD