Associate Director, CMC Regulatory Affairs - Small Molecules

Scorpion Therapeutics; United States; Remote; USD 190,000 - 260,000; Full time

Job summary

Scorpion Therapeutics is seeking an Associate Director of CMC Regulatory Affairs to lead global CMC regulatory strategies for small molecule drug development and commercialization, with emphasis on oral solid dosage forms. You will own submissions, liaise with global health authorities, and guide cross-functional teams through lifecycle management.

The role requires 8+ years in regulatory affairs, strong CMC expertise, and the ability to drive regulatory plans across INDs, NDAs, and

Qualifications

• Bachelor's in Pharmaceutical Sciences, Chemistry, or related field; 8+ years in pharmaceutical regulatory affairs with extensive CMC experience supporting small molecules from IND through post-market.
• Preferred: MS, PhD, or PharmD.
• High-value: expertise in oral solid dosage products, global regulatory submissions, lifecycle management, and interactions with health authorities.

Responsibilities

• Develop and execute global CMC regulatory strategies and lead submissions.
• Liaise with health authorities (FDA, EMA, PMDA, GCC) and manage lifecycle changes.
• Collaborate with Development, Manufacturing, Quality, Regulatory Operations & Supply Chain to ensure compliance and timely submissions.
• Provide regulatory guidance on formulation development, process validation, transfer, analytics, and post-approval changes.

Skills

Regulatory strategy

Submission leadership

Global regulatory

Cross-functional collaboration

Education

Bachelor's in Pharmaceutical Sciences

MS/PhD/PharmD preferred

Tools

eCTD

Job description

Role:

Associate Director, CMC Regulatory Affairs responsible for strategic and operational leadership of CMC activities supporting small molecule drug development and commercialization, primarily oral solid dosage forms.

Responsibilities:

• develop and execute global CMC regulatory strategies, lead submissions (INDs, NDAs, amendments, variations), liaise with health authorities (FDA, EMA, PMDA, GCC), and support lifecycle management including manufacturing changes and site transfers. Collaborate closely with Pharmaceutical Development, Manufacturing, Quality, Regulatory Operations, and Supply Chain teams to ensure compliance, alignment, and timely submissions. Provide technical regulatory guidance on formulation development, process validation, process transfer, analytical methods, and post-approval changes.

Qualifications:

• Bachelor's in Pharmaceutical Sciences, Chemistry, or related field; 8+ years in pharmaceutical regulatory affairs with extensive CMC experience supporting small molecules from IND through post-market.
• Preferred: advanced degree (MS, PhD, PharmD).
• High-value: expertise in oral solid dosage drug products, global regulatory submissions, lifecycle management, and interactions with global health authorities.

Work setup:

Remote in San Diego, with approximately 10% travel domestically and internationally.