Director, Regulatory Affairs CMC (Pharma)

TL;DR

Director, Regulatory Affairs CMC (Pharmaceuticals): Defining and executing global CMC regulatory strategies for development programs from early-stage through commercialization with an accent on global compliance and regulatory submissions. Focus on leading IND, IMPD, BLA/MAA filings and managing complex interactions with Health Authorities.

Location: Primarily remote, with potential for occasional on-site presence in Waltham, MA. Must align with EST hours.

Company

A consulting firm providing end-to-end regulatory, clinical, and quality solutions to biotech and pharmaceutical organizations to accelerate drug and device programs.

What you will do

• Lead and execute global CMC regulatory strategies across all phases of development (IND, IMPD, BLA/MAA).
• Oversee the planning, development, and delivery of CMC sections for global regulatory submissions.
• Manage regulatory activities related to clinical and commercial manufacturing changes.
• Partner with Manufacturing, Quality, and Clinical Operations teams to deliver key milestones.
• Identify regulatory risks and develop mitigation strategies to support program success.
• Coordinate global submissions and product registration maintenance throughout the lifecycle.

Requirements

• Bachelor’s degree in Life Sciences; MS or PhD preferred.
• 10+ years of experience in biotechnology or pharmaceuticals.
• 7+ years in Regulatory Affairs with a strong focus on CMC.
• Proven experience leading BLA/MAA submissions and interacting with FDA and EMA.
• Deep understanding of CTD structure, ICH guidelines, and global regulatory frameworks.
• Ability to operate independently in a fast-paced biotech environment.

Culture & Benefits

• Commitment to diversity, equity, and inclusion.
• Flexible remote work policy with encouraged hybrid collaboration for those near offices.
• Human-centric hiring process with personal review of all applications and no AI screening tools.
• Supportive environment encouraging innovative and entrepreneurial spirits.