Senior CMC Regulatory Lead — Global Submissions

Scorpion Therapeutics

United States

Remote

USD 190,000 - 260,000

Full time

5 days ago

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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.