Director/Associate Director, Regulatory Affairs CMC

Role Summary

Director/Associate Director, Regulatory Affairs CMC responsible for developing and executing global regulatory CMC strategies across multiple modalities, managing key deliverables, and ensuring adherence to accelerated regulatory submission schedules. This role involves communications and interactions with global regulatory authorities and cross-functional collaboration to maintain alignment with regulatory CMC strategies and compliance requirements.

Responsibilities

• Develop and execute global regulatory CMC strategies across clinical and commercial stages.
• Serve as the regulatory CMC lead on cross-functional teams, providing strategic input to technical operations, supply chain, quality and project teams.
• Author, review and manage the preparation of high-quality CMC sections for regulatory submission (e.g. IND, CTAs, IMPD, annual reports, pediatric plans, amendments, and marketing applications).
• Lead interactions with global health authorities on CMC topics, including preparation of briefing packages, responses to information requests, and representation at meetings.
• Collaborate with internal and external stakeholders to ensure regulatory compliance and alignment with regulatory CMC strategies.
• Maintain current knowledge of regulations and guidelines (e.g., ICH, FDA, EMA) and keep abreast of changes in the global regulatory environment.
• Support regulatory inspections, as required.

Qualifications

• Bachelor‚Äôs degree in a relevant scientific discipline; advanced degree a plus.
• A minimum of 7 years of relevant pharmaceutical/bi biotechnology industry experience, including 5+ years in regulatory CMC.
• Hands-on experience with CMC submission preparation for small molecules, biologics, and/or antibody-drug conjugates.
• Experience with regulatory CMC strategy development and health authority interactions.

Knowledge And Skills

• Deep understanding of ICH, FDA and EMA guidelines.
• Outstanding communication, analytical, organizational and time management skills.
• Strong written and verbal communication abilities with attention to detail.
• Ability to effectively lead cross-functional teams.
• Flexible work style with a pragmatic approach to rapidly changing priorities.
• Proficiency in submission management software, such as Veeva RIM.

Education

• Not specified beyond the Bachelor's degree requirement.