Regulatory Affairs Executive - UK cGMP Generics

Select Pharma Recruitment; Windsor; On-site; GBP 40,000 - 60,000; Full time

Job summary

Select Pharma Recruitment is seeking a Regulatory Affairs Executive for their Berkshire-based client. The role is fully office-based (5 days a week) with no hybrid option, focusing on cGMP for solid dosage generic products.

You will prepare submissions to the MHRA, manage variations and renewals, handle license transfers, and respond to deficiencies. Mentoring and cross-functional liaison are key parts of the role.

Qualifications

• Pharmacy or chemistry degree required.
• Background in R&D and manufacturing industries preferred.
• Regulatory affairs experience with UK/EU rules is essential.

Responsibilities

• Prepare and submit regulatory applications to MHRA via National Procedure.
• Handle variations, including Type 1A/1B, II, and labeling changes.
• Maintain Marketing Authorisations and renewals; manage license transfers.
• Reply to deficiencies from authorities and liaise with regulators for guidance.
• Coach junior team members and coordinate with internal and external stakeholders.

Education

Pharmacy/Chemistry degree

Job description

Select Pharma Recruitment is seeking a Regulatory Affairs Executive for their Berkshire-based client. The role is fully office-based (5 days a week) with no hybrid option, focusing on cGMP for solid dosage generic products.

You will prepare submissions to the MHRA, manage variations and renewals, handle license transfers, and respond to deficiencies. Mentoring and cross-functional liaison are key parts of the role.