Senior Regulatory Affairs Lead - UK/EU Submissions & CMC

Select Pharma Limited; United Kingdom; On-site; GBP 40,000 - 55,000; Full time

Job summary

A prominent pharmaceutical company in the United Kingdom seeks a Regulatory Affairs Specialist to provide full regulatory support for products. The ideal candidate will have significant experience across the product lifecycle, particularly with CMC regulatory submissions. Responsibilities include managing submission timelines and ensuring compliance with UK and EU regulations. This full-time role requires strong communication and organizational skills.

Qualifications

• Degree in a suitable scientific discipline (biological/chemistry/life sciences).
• Substantial regulatory experience across the full product lifecycle.
• Strong CMC regulatory experience, including preparation and review of Module 3 CTD.
• Solid understanding of pharmaceutical manufacturing processes.
• Broad experience managing regulatory submissions.
• In-depth knowledge of UK and European regulatory affairs legislation.

Responsibilities

• Provide regulatory input and support across the submission phase.
• Ensure regulatory submissions are timely and communicate delays effectively.
• Review quality documentation for regulatory compliance.
• Provide regulatory input on artworks for product launches.

Skills

Regulatory experience

Strong CMC knowledge

Planning and organisation

Effective communication

Negotiation skills

Education

Degree in biological sciences

Job description

A prominent pharmaceutical company in the United Kingdom seeks a Regulatory Affairs Specialist to provide full regulatory support for products. The ideal candidate will have significant experience across the product lifecycle, particularly with CMC regulatory submissions. Responsibilities include managing submission timelines and ensuring compliance with UK and EU regulations. This full-time role requires strong communication and organizational skills.