Position Title: Associate Director, Regulatory Affairs - Chemistry, Manufacturing, and Controls (CMC)
Location: Waltham, MA (On-site only)

No Third Parties Please!

Role Overview:
The Associate Director, Regulatory Affairs CMC, is responsible for global CMC regulatory strategies for programs in early and late-stage development through and beyond approval. This position supports clinical registration, commercial development, and manufacturing efforts, as applicable. The role involves collaboration with manufacturing, clinical operations, quality, other regulatory team members, and program teams.

Key Responsibilities:

Strategic Leadership: Develop and implement global regulatory CMC strategies, providing guidance to internal teams and external partners to meet program objectives
Regulatory Documentation: Lead the preparation of CMC sections for regulatory submissions (e.g., IND, IMPD, BLA), ensuring high-quality, compliant documents
Health Authority Interactions: Serve as the primary point of contact for regulatory agencies, preparing responses to inquiries and representing the company in meetings
Cross-Functional Collaboration: Partner with manufacturing, quality, clinical operations, and other departments to align regulatory strategies with development plans
Compliance Oversight: Monitor and manage global submissions, ensuring timely updates and adherence to regulatory commitments
Risk Management: Utilize technical and regulatory expertise to identify potential risks and implement mitigation strategies
Team Leadership: Provide mentorship and guidance to junior staff, fostering a collaborative and high-performance environment

Qualifications:

Education: Bachelor's degree in life sciences or a related discipline is required
Experience: Minimum of 7 years in the biotech/pharmaceutical industry, with at least 5 years in regulatory affairs within clinical-stage and/or commercial biotechnology companies
Specialized Knowledge: Experience in rare diseases and biologics is preferred
Regulatory Expertise: In-depth understanding of FDA regulatory guidance, ICH guidelines, and global regulatory CMC requirements.
Technical Proficiency: Strong experience with CTD format and content of regulatory filings
Communication Skills: Excellent verbal and written communication abilities, with a keen attention to detail
Leadership Abilities: Rrecord of effective collaboration and leadership in cross-functional teams.