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Job description
Position Summary Director, Regulatory CMC. Role can be based in San Diego, CA; San Francisco, CA; or Princeton, NJ. Hybrid model: work in office three days per week on average.
Primary Responsibilities
Manage CMC regulatory affairs for marketed products and compounds in development (US and ex-US).
Coordinate with R&D, Pharmaceutical Development, Manufacturing, Quality, Regulatory, and other functions to develop/implement CMC regulatory strategy.
Prepare high-quality CMC sections of INDs, CTAs, NDAs, MAAs, and amendments for worldwide submissions.
Serve as CMC regulatory representative; primary point of contact with regulatory agencies for CMC development, registration, and lifecycle activities.
Provide CMC regulatory guidance/strategy to development teams and identify/assess/mitigate regulatory risks.
Ensure CMC compliance with applicable regulatory requirements.
Evaluate manufacturing processes/changes for 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 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; strong organization/detail; deadline management; initiative and ability to work with limited supervision.
Ability to negotiate/influence senior leaders.
Willingness and ability to travel domestically and internationally.
Benefits/Compensation (as stated)
Salary range: $189,700—$237,100 USD.
Discretionary bonus and equity awards; medical/dental/vision; life/disability/travel/EAP; 401(k) match; ESPP; 15+ vacation; 13–15 paid holidays; sick time; paid parental leave; tuition assistance.
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Worksite address
princeton, NJ, 08543, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.