Senior Regulatory Affairs Specialist PRN (Remote)

Pace® Analytical Services•PLS - Remote (MN), MA

19d•Remote

About The Position

Are you ready to work making the world a safer, healthier place? Join our mission to continuously move science forward; to innovate and advance all aspects of our business to improve the health and safety of our communities and lives. Lead and execute global regulatory strategies to ensure our client’s investigational, new, and marketed products are developed and maintained in compliance with global regulatory requirements. Serve as a strategic advisor to clients, ensuring regulatory compliance, influencing key stakeholders, and optimizing business outcomes.

Requirements

B.A. / B.A./ M.S. / Ph.D. in biochemistry, chemistry, biology, or related pharmaceutical field with a minimum of 10+ years of experience in CMC /regulatory affairs
Hands-on experience authoring and compiling CMC sections of INDs, IMPDs, CTAs, amendments, and related filings.
Strong knowledge of global CMC clinical regulatory requirements and guidelines, including FDA, EMA, and ICH.
Excellent attention to detail, technical writing, organizational, and communication skills.
Ability to manage multiple deliverables and timelines in a fast-paced environment.
Proficiency with regulatory document management systems.

Responsibilities

Author and compile CMC sections of regulatory applications, including INDs, IMPDs, CTAs, amendments, and annual reports.
Draft and maintain high-quality CMC regulatory documents such as Module 2 and 3 summaries, stability reports, and comparability protocols.
Support regulatory interactions by preparing responses to CMC-related questions from FDA, EMA, PMDA, and other global health authorities.
Prepare and Lead Regulatory interactions for CMC regulatory strategies to support clinical trial initiation and advancement.
Contribute to the development of templates, processes, and workflows to support efficient and compliant CMC regulatory operations.
Other duties as assigned.