Job Description

Director Regulatory Affairs CMC

I am looking to speak with Director's of Regulatory Affairs CMC to lead the development and execution of global CMC regulatory strategies for clinical-stage small molecule programs.

In this highly collaborative role, you will provide Regulatory-CMC expertise to support product development, regulatory submissions, and health authority interactions.

Reporting to the Vice President of RA & QA, you will work closely with cross-functional teams and external partners to navigate complex regulatory challenges and contribute to the advancement of transformative therapies.

This is an exciting opportunity to shape regulatory pathways in a fast-moving environment and make a meaningful impact on the development of innovative medicines.

Key Responsibilities

• Develop and implement Domestic and Global Regulatory-CMC strategies that align with clinical development plans and long-term regulatory expectations.
• Define CMC regulatory requirements to support efficient development pathways while balancing speed, risk, and compliance.
• Support product development, manufacturing changes, and quality systems compliance throughout the product lifecycle.
• Proactively identify risks and collaborate cross-functionally to create mitigation strategies.
• Partner with CMC, Quality, and Supply Chain teams to integrate regulatory considerations into manufacturing processes and supply chain planning.
• Oversee planning, preparation, and review of high-quality, phase-appropriate CMC documentation for global regulatory submissions.
• Lead CMC-related interactions with health authorities, clearly communicating regulatory strategies and ensuring alignment.
• Monitor evolving global regulatory trends and apply key insights to shape internal strategies and inform decision-making.

Leadership Expectations

As a Director, you will be expected to demonstrate leadership across the following areas:

• Build open communication channels to share critical regulatory insights.
• Influence senior decision-making through clear, persuasive arguments.
• Respectfully engage in differing viewpoints to drive aligned outcomes.
• Foster strong cross-functional partnerships and team alignment.
• Address team dynamics proactively to support collaboration.
• Identify and address execution gaps to ensure delivery of goals.
• Anticipate and remove obstacles to functional and corporate success.
• Support team growth by removing barriers and encouraging autonomy.
• Stay informed on industry developments to keep the team prepared and agile.

Qualifications

• Advanced degree (Master’s or Ph.D.) in Chemistry, Pharmaceutical Sciences, or a related field preferred (or equivalent experience).
• 10+ years of industry experience with in-depth expertise in Regulatory Affairs CMC.
• Strong knowledge of global CMC regulations, ICH guidelines, and requirements for small molecules.
• Experience supporting manufacturing and development activities with CMOs and external vendors.
• Background in early-phase clinical development and ability to adapt strategies through later stages.
• Proven success in managing health authority interactions on CMC topics.
• Strong organizational skills, with the ability to manage multiple projects in a fast-paced environment.

If you are interested in finding out more please Easy Apply with your updated resume or email me on Charman@barringtonjames.com or call me on 919-647-9154

Notes :

• This is a Hybrid role in the Bay Area, seeking at least 2 days week, will consider candidates outside of the Bay as long as an agreeable schedule can be made
• Sponsorship can be considered

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