CMC Regulatory Affairs Director — Strategy & Submissions

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

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