Regulatory Affairs Manager

We're recruiting an experienced Regulatory Affairs Manager for a contract role supporting a UK product portfolio. You'll own UK regulatory strategy and submissions, manage MHRA interactions, and keep the portfolio compliant across its lifecycle, working closely with global regulatory, quality, clinical and manufacturing teams.

Location: London, UK
Day rate: £500–£600 per day (IR35 status to be confirmed)
Contract: Initial 6–12 months, likely extension

What you'll do:

• Develop and execute UK regulatory strategies for new applications, variations, renewals and lifecycle management
• Prepare and submit MHRA filings, including GB/NI requirements under the Windsor Framework
• Act as primary MHRA contact, managing queries, scientific advice meetings and responses
• Review and approve labelling, packaging and promotional materials (SmPC, PIL, artwork)
• Assess the regulatory impact of manufacturing, CMC and quality changes
• Align UK submissions with EU, US and ROW strategies

What you'll bring:

• Life sciences degree (Pharmacy, Chemistry, Biology, Biochemistry or similar)
• 5–8 years’ regulatory affairs experience in pharma, biotech or medical devices
• Proven UK/MHRA submissions experience (MAAs, variations, renewals and/or CTAs)
• Strong knowledge of the post-Brexit UK framework, EMA and ICH guidelines
• Right to work in the UK

Desirable: eCTD publishing, Veeva Vault RIM, MHRA inspection experience, previous contract/interim roles.

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