Global Regulatory Affairs CMC Lead, Raleigh, NC

Make your mark for patients

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 Raleigh, NC,headquarters.

About the role
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.

Who you’ll work with
You will represent GRA-CMC & Devices on Global Regulatory Affairs teams and partner with cross-functional stakeholders, including Patient Supply and patient value teams. You will also collaborate with the Global Regulatory Affairs CMC Team Lead, the GRA-CMC & Devices Leadership Team, and other internal subject matter experts to align strategy, manage risks, and deliver submissions on time.

What you’ll do

• 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.

Interested? For this role we’re looking for the following education, experience and skills

Minimum Qualifications

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

Preferred Qualifications

• 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.

Internal applicants should be in their current job for at least 12 months, must meet performance standards and are not on formal corrective/disciplinary process (PIP), warning, final warning, or compliance warning letters within the last 12 months. Please inform your Manager or your Talent Partner before applying to any internal job opportunities.

Unlessexplicitlystated in the description, this role is hybrid with 40% of your time spent in the office,regardlessof your current contractual agreement. If your current working arrangements differ, please contact your Talent Partner to discuss before submitting your application.

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 US-Reasonable_Accommodation@ucb.com 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.

Requisition ID: 92846

Recruiter: Kevin Ross

Hiring Manager: Eva Castro

Talent Partner: Bianca Hinshaw

Job Level:MM I

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