Global Regulatory Affairs CMC Lead

UCB • Raleigh, NC

5d • Hybrid

About The Position

You will lead regulatory strategies, planning and preparation of global or regional specific CMC submissions for assigned projects/products across the full product lifecycle, from early development to post approval. Working closely with cross functional teams, you will shape high quality regulatory documentation, engage with health authorities, and support timely approvals that meet patient and business needs. This role plays a key part in ensuring regulatory excellence and continuous improvement across global markets.

Requirements

• A degree in a scientific or technical discipline; advanced or regulatory qualifications are an advantage.
• Extensive experience in pharmaceutical industry and in regulatory roles, including global submissions and working with health authorities supporting regulatory discussions
• Excellence and proven track record of successful regulatory strategic authoring and contribution to delivering regulatory CMC documentation of new marketing authorisations, clinical trial applications and post-approval submissions.
• Experience working with health authorities and supporting regulatory discussions and responses.
• Demonstrated ability to leverage digital tools, structured data, and regulatory information systems to enhance regulatory strategy, submission quality, lifecycle management, and decision‑making across global markets.
• Ability to participate or lead and embed digital and process innovation initiatives within the team, driving harmonization, efficiency, and regulatory excellence across cross‑functional and global teams.

Responsibilities

• Define and deliver regulatory strategies for global or regional specific CMC submissions for assigned projects/products across development and post approval stages.
• Lead complex regulatory submissions, ensuring consistency, quality, and alignment with agreed global strategies.
• Author and review regulatory CMC documentation within agreed timelines.
• Represent regulatory CMC expertise in cross functional project teams and authority interactions, as needed.
• Anticipate risks across the product lifecycle and communicate solutions clearly to key stakeholders.
• Support process improvement initiatives and mentor colleagues within the regulatory team.

What This Job Offers

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