Director, Regulatory Affairs CMC
$189.7k - $237.1kScorpion Therapeutics
Position Summary Director, Regulatory CMC. Hybrid role (office ~3 days/week) in San Diego, CA; San Francisco, CA; or Princeton, NJ. 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, and other functions to develop/implement CMC regulatory strategy. Lead timely preparation of CMC sections of INDs, CTAs, NDAs, MAAs, and amendments for global submissions. Serve as regulatory CMC expert and point of contact for agencies on CMC development, registration, and lifecycle activities. Provide CMC guidance/risk identification and mitigation for development teams. Ensure CMC compliance with applicable regulations/guidelines. Evaluate manufacturing processes/changes; assess regulatory implications; support implementation. Maintain knowledge of relevant regulations and determine applicability. Education/Experience/Skills BS in life science (or related); equivalent education/experience considered. ~10 years progressively responsible CMC Regulatory Affairs (small molecules), including 5 years in management. Knowledge of global regulatory CMC requirements. Experience preparing/submitting CMC components of IND/CTA, briefing packages, NDA, and ex-US MAA. Cross-functional collaboration; strong organization; detail-oriented; deadline management. Negotiation/influencing skills; initiative; ability to work with limited supervision. Willingness to travel domestically/internationally. Compensation/Benefits Discretionary bonus and equity awards. Salary range: $189,700–$237,100. Medical/dental/vision; life/disability/travel/EAP; 401(k) match (1:1 up to 5%); ESPP; 15+ vacation; 13–15 paid holidays; 10 paid sick days; paid parental leave; tuition assistance. #J-18808-Ljbffr
Vacancy posted 2 days ago
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