Associate Director, Regulatory Affairs CMC
Vivid Resourcing, Cambridge, MA, United States
We are seeking an experienced Associate Director, CMC Regulatory Affairs to lead and support global regulatory strategy for Chemistry, Manufacturing and Controls (CMC) across development programs. This role will provide strategic regulatory guidance for biologics and/or complex therapeutic products and will be responsible for CMC regulatory submissions and health authority interactions throughout the product lifecycle.
The successful candidate will partner closely with CMC, Quality, Manufacturing, Clinical Development, and Regulatory teams to ensure regulatory compliance and successful execution of INDs, BLAs, and global regulatory filings .
Key Responsibilities
- Lead the development and execution of global CMC regulatory strategies for biologics programs from early development through licensure and lifecycle management.
- Author and oversee CMC sections of regulatory submissions , including INDs, BLAs, and global marketing applications .
- Support preparation and submission of regulatory filings to global health authorities including FDA, EMA, and other international agencies .
- Serve as the CMC regulatory lead on cross-functional development teams.
- Provide strategic guidance on manufacturing changes, comparability, process development, and product lifecycle management .
- Lead preparation of responses to health authority questions and information requests related to CMC.
- Support regulatory interactions and meetings with health authorities, including FDA Type B meetings and EMA scientific advice .
- Ensure compliance with applicable global regulatory requirements, guidelines, and ICH standards .
- Collaborate with internal stakeholders and external partners to ensure timely preparation and submission of high-quality regulatory documentation .
- Provide regulatory guidance to CMC teams on regulatory expectations, submission requirements, and development strategies .
- Support regulatory strategy for post-approval changes, supplements, and lifecycle management activities .
Required Qualifications
- Advanced degree in life sciences, chemistry, biochemistry, pharmaceutical sciences, or related field (PhD, MS, or equivalent experience).
- 8+ years of regulatory affairs experience , including significant experience in CMC regulatory affairs .
- Direct experience with IND and BLA regulatory submissions .
- Experience preparing CMC sections of regulatory dossiers .
- Working knowledge of global regulatory requirements including FDA, EMA, and ICH guidelines .
- Experience supporting global regulatory filings and health authority interactions .
- Strong understanding of biologics manufacturing, process development, and analytical control strategies .
- Excellent communication, leadership, and cross-functional collaboration skills.
Preferred Qualifications
- Experience supporting successful BLA submissions and/or approvals .
- Experience with global regulatory submissions (EU, UK, Canada, or Asia) .
- Prior experience interacting directly with FDA or other regulatory agencies .
- Experience supporting regulatory strategy for complex biologics or novel modalities .
- Background working in biotechnology or innovative therapeutic development environments .
- Strategic regulatory thinking
- Strong knowledge of global CMC regulatory requirements
- Cross-functional leadership
- Ability to manage complex regulatory submissions
- Strong project management and organizational skills