Director, Regulatory Affairs CMC

Scorpion Therapeutics; San Diego (CA); Hybrid; USD 190,000 - 237,000; Full time

Benefits offered by this job

Discretionary bonus

Equity awards

401(k) match

ESPP

Health benefits

Tuition assistance

Job summary

Scorpion Therapeutics is seeking a Director, Regulatory CMC for a hybrid role (office ~3 days/week) in San Diego, San Francisco, or Princeton. You will lead CMC regulatory strategies for US and ex-US programs and collaborate with R&D, Manufacturing, Quality, and Regulatory teams.

Responsibilities include preparing CMC sections of INDs, CTAs, NDAs, and MAAs; serving as the regulatory CMC expert to agencies; guiding risk management; ensuring compliance and timely submissions; and evaluating

Qualifications

• BS in life science or related field; equivalent education/experience.
• ~10 years CMC Regulatory Affairs experience with 5 years in management.
• Knowledge of global regulatory CMC requirements.
• Experience preparing/submitting CMC components of IND/CTA, NDA, and ex-US MAA.

Responsibilities

• Lead CMC regulatory strategy for US and ex-US products.
• Coordinate with R&D, Development, Manufacturing, QA to implement strategy.
• Lead timely preparation of CMC sections of INDs, CTAs, NDAs, MAAs, and amendments.
• Serve as regulatory CMC expert and project liaison with agencies.
• Provide CMC guidance and risk mitigation for development teams.
• Ensure CMC regulatory compliance with applicable regulations.
• Evaluate manufacturing processes/changes for regulatory impact.

Skills

CMC Regulatory Affairs

Regulatory leadership

Global regulatory

IND/CTA/ NDA submissions

Cross-functional collaboration

Project management

Travel readiness

Education

BS in Life Science

Job description

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.