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.
Vacancy posted 3 days ago
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