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. 

Compensation: $150,000.00 - 175,000.00 per year

Key Responsibilities: 

• Regulatory Submissions: Author and compile CMC sections of regulatory applications, including INDs, IMPDs, CTAs, amendments, and annual reports. 

• Documentation: Draft and maintain high-quality CMC regulatory documents such as Module 2 and 3 summaries, stability reports, and comparability protocols. 

• Communication: Support regulatory interactions by preparing responses to CMC-related questions from FDA, EMA, PMDA, and other global health authorities. 

• Strategy Implementation: Prepare and Lead Regulatory interactions for CMC regulatory strategies to support clinical trial initiation and advancement. 

• Process Development: Contribute to the development of templates, processes, and workflows to support efficient and compliant CMC regulatory operations. 

• Other duties as assigned. 

Ideal Candidate: 

• 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.