Global Regulatory Affairs CMC Lead, Atlanta, GA

UCB • Atlanta, GA

11d • Hybrid

About The Position

We are looking for a Global Regulatory Affairs CMC & Devices Lead who is strategic, collaborative, and detail-oriented to join our Global Regulatory Affairs CMC & Devices team, based at our Atlanta, GA, headquarters. As the Global Regulatory Affairs CMC & Devices Lead, you will define strategy, plan, and deliver high-quality CMC and/or medical device submission documentation across the product lifecycle (clinical through marketing application and post-approval). You will lead authoring of key submission components, drive timely responses to health authority questions, and partner closely with cross-functional teams to ensure regulatory alignment and approvals that meet business needs.

Requirements

• Bachelor’s degree.
• Minimum of 8 years pharma/medical device industry or authority experience.
• Minimum of 5 years of Regulatory Affairs CMC/Device experience.

Nice To Haves

• Experience authoring CMC sections for submissions across lifecycle stages.
• Strong cross-functional leadership in matrix organizations.
• Direct negotiation experience with global/regional health authorities.
• Knowledge of GMP and change management systems.
• Experience with software as a medical device and/or in vitro diagnostics.
• Experience driving digital/process innovation for regulatory submissions.
• Broad ICH region registration experience (development and post-approval).
• University certificate in regulatory affairs (preferred).
• Experience representing the company in external regulatory forums.
• Demonstrated mentoring/coaching of junior regulatory staff.

Responsibilities

• Define CMC/Device regulatory strategy and submission plans.
• Author and deliver Module 3 and support submission content.
• Lead CMC/Device interactions with Health Authorities and Notified Bodies.
• Drive cross-functional responses to agency questions and requests.
• Communicate strategy, risks, and plans to key internal stakeholders.
• Monitor regulatory intelligence and support internal process improvements.

Benefits

• UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable federal, state, or local law. UCB invites you to voluntarily self-identify during the application process. Provision of self-identification information is entirely voluntary and a decision to provide or not provide such information will not have any effect on your application for employment, your employment with UCB, or otherwise subject you to any adverse treatment. Any information you provide will be considered confidential and will be kept separate from your application and/or personnel file and will only be used in accordance with applicable laws, orders, and regulations.
• Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [email protected] for application to US based roles. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level