Regulatory Affairs Executive

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

An excellent opportunity has arisen for a Regulatory Affairs Executive to join my client based in Berkshire and focusing on cGMP, solid dosage generic pharmaceuticals.

++ Please note that this role is fully office based (5 days per week) and hybrid working is not available ++

Responsibilities:

• Prepare and submit applications of reliable quality in a timely manner to MHRA (UK) via National Procedure. These include new licence applications, variations (including grouping and work sharing), renewals, artwork changes, RFIs, updates and any other relevant applications or notifications.
• Have a good understanding of and be able to execute activities related to the following key areas;
• Variations: Type 1A, 1B, II, Labelling changes including own label supplies, safety updates and line extensions.
• Reclassification of Medicines.
• Re-baseline / Remediation dossiers.
• License Transfers (giving away and bringing in) including the due diligence of dossiers.
• Maintenance of Marketing Authorisations including renewals.
• Deficiency responses to authorities.
• Partake in the interfacing with regulatory authorities to facilitate the approval of submissions.
• Act as a point of contact for other business units, customers, and internal/external teams.
• Stay informed about new and changing regulatory requirements and ensuring compliance.
• Assist in coaching and mentoring junior members of the team.
• Liaise with regulatory authorities for advice and guidance when necessary, and to resolve issues to achieve the best possible outcome for the business.

Required Skills:

• Pharmacy/Chemistry degree.
• A background in R&D and manufacturing industries.
• Significant Regulatory Affairs experience.
• Understanding of the current UK and European regulations, laws, guidelines and industry requirements.
• Exposure to NeeS/eCTD format and electronic submission gateways is preferable.
• Experience with Generic products and MRP/DCP submissions is advantageous.