Regulatory Affairs Manager

Myn; Greater London; Vor Ort; GBP 92.000 - 111.000; Vollzeit

Zusammenfassung

Myn is seeking an experienced Regulatory Affairs Manager for a contract role in London to own UK regulatory strategy and submissions, manage MHRA interactions, and keep a pharma/biotech portfolio compliant across its lifecycle.

You will collaborate with global regulatory, quality, clinical and manufacturing teams, prepare MHRA filings including GB/NI under Windsor Framework, and liaise as primary MHRA contact.

Qualifikationen

• 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 post-Brexit UK framework, EMA and ICH guidelines.
• Right to work in the UK.

Aufgaben

• 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

Kenntnisse

UK regulatory strategy

Regulatory submissions

Stakeholder management

Ausbildung

Life sciences degree

Tools

eCTD publishing

Veeva Vault RIM

Jobbeschreibung

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.