Senior Manager, Regulatory Affairs CMC

An innovative and fast-growing life sciences consultancy is seeking a Senior Manager of Regulatory Affairs – CMC to support a diverse portfolio of biologic development programs. This fully remote opportunity is ideal for someone experienced in biologics CMC who thrives in a high-paced, client-facing environment.

We're looking for a proactive and communicative regulatory professional with experience spanning early development to post-approval, ideally with a CRO or consultancy background. You’ll be part of a dynamic and collaborative team, helping clients navigate the complexities of global regulatory landscapes.

Key Responsibilities

• Drive CMC regulatory strategy and execution across development and post-approval stages for biologics
• Prepare, review, and manage regulatory submissions (INDs, IMPDs, BLAs, variations, supplements)
• Act as a key liaison between internal teams, clients, and regulatory authorities
• Support business development activities through client engagement and consultation
• Maintain awareness of global regulatory trends and proactively manage risks
• Provide guidance to cross-functional teams on CMC regulatory expectations

Your Profile

• 5–10 years of experience in Regulatory Affairs CMC with a strong focus on biologics (not small molecules)
• Solid track record of managing regulatory submissions across the product lifecycle
• Strong communication skills and the ability to build trusted relationships with clients and agencies
• Previous experience in a CRO, consultancy, or fast-paced biotech setting preferred
• Agile, dependable, and confident in taking initiative—including occasional BD-related tasks
• Fluent in English; EU-based preferred, but open to global applicants with the right experience

What’s On Offer

• Fully remote role with flexible working hours
• Opportunity to work across innovative biologic therapies and global regulatory pathways
• Impactful, strategic role in a growing and collaborative team
• Exposure to early-stage and post-approval regulatory environments