Director/Senior Director Regulatory CMC

Director / Senior Director Regulatory CMC

A clinical stage biotech focused on the development of high-quality therapeutic candidates is seeking a Director / Senior Director Regulatory CMC to join their growing team. This organization is leveraging strong scientific capabilities and a streamlined development approach to drive programs forward.

The Director/Senior Director of Regulatory CMC will provide strategic and operational regulatory support for chemistry, manufacturing, and controls (CMC) activities across the product lifecycle. This leader will develop global regulatory strategies, oversee the preparation and submission of high‑quality CMC documentation, and ensure compliance with applicable regulatory requirements. The role partners closely with Regulatory Affairs leadership and cross‑functional development teams.

Responsibilities

• Lead the development and execution of global CMC regulatory strategies for clinical and commercial programs.
• Oversee the preparation, review, and submission of CMC sections for regulatory applications, including clinical trial applications and marketing submissions.
• Manage regulatory CMC timelines, deliverables, and overall submission quality to support corporate objectives.
• Conduct regulatory assessments of proposed CMC changes and identify global filing requirements.
• Prepare and submit amendments, updates, and other CMC‑related regulatory documentation throughout the product lifecycle.
• Lead or participate in formal CMC‑focused regulatory interactions, including meeting requests, briefing packages, and agency meetings.
• Serve as the primary contact for CMC‑related discussions with regulatory authorities, and support negotiations to resolve issues.
• Monitor, interpret, and communicate relevant global regulatory requirements, guidelines, and emerging trends.
• Represent Regulatory CMC on cross‑functional project teams and contribute to development strategy and risk assessments.
• Support the creation, review, and implementation of departmental policies, procedures, and process improvements.

Qualifications

• Advanced degree (e.g., Ph.D., M.S.) in chemistry, pharmaceutical sciences, engineering, or related scientific discipline preferred; relevant experience may substitute.
• 5-10+ years of regulatory CMC or CMC‑related experience within the biopharmaceutical or pharmaceutical industry.
• Demonstrated experience preparing, reviewing, and managing CMC content for global regulatory submissions (e.g., INDs/CTAs, marketing applications) in eCTD format.
• Experience interacting with regulatory agencies and leading formal regulatory meetings.
• Strong understanding of global CMC regulatory requirements, including FDA, EU, and ICH guidelines.
• Excellent organizational and project management skills, with the ability to manage multiple priorities in a dynamic environment.
• Highly motivated team player with strong interpersonal, written, and verbal communication skills.
• Ability to work independently while effectively collaborating with cross‑functional partners.