Regulatory Affairs Executive

Regulatory Affairs Executive - Pharmaceuticals - Manchester

Smart4 Sciences is partnering with a growing pharmaceutical group to recruit a Regulatory Affairs Executive to support and manage a diverse portfolio of UK licences across parallel import, licensing, and manufacturing operations.

This is an excellent opportunity for a regulatory professional with strong MHRA exposure who enjoys ownership, problem-solving, and cross-functional collaboration within a fast-moving pharmaceutical environment.

The Role

As Regulatory Affairs Executive, you will manage a portfolio of licences end-to-end, ensuring compliant, high-quality submissions to the MHRA while acting as a subject-matter expert for complex licensing scenarios. You will also deputise for the Senior Regulatory Officer when required.

Key focus areas include PLPI applications, variations, renewals, and ongoing regulatory compliance across multiple business units.

Key Responsibilities

• Manage and maintain your own portfolio of UK pharmaceutical licences
• Prepare, submit, and manage PLPI licence applications, variations, and renewals
• Act as a key point of contact with the MHRA, proactively resolving RFIs and clarifying requirements
• Ensure submissions are approved first time or with a maximum of one RFI
• Maintain accurate regulatory records and updates within internal systems
• Support buyers and internal stakeholders with up-to-date regulatory guidance
• Identify regulatory changes and assess business impact
• Lead or contribute to continuous improvement and process optimisation initiatives
• Project manage regulatory aspects of major legislative or procedural changes
• Deputise for the Senior Regulatory Officer when required

About You

You will be a detail-driven regulatory professional with a strong compliance mindset and a proactive, solutions-focused approach.

Essential:

• Regulatory Affairs or Quality experience within the pharmaceutical industry
• Good working knowledge of GMP
• Experience working with MHRA submissions and regulatory documentation
• Strong written English, grammar, and attention to detail
• Excellent organisational, communication, and stakeholder management skills
• Confident working independently while collaborating cross-functionally

Desirable:

• Degree in a scientific discipline (Pharmaceutical Sciences preferred)
• Experience with parallel import licences (PLPI)
• Exposure to artwork authoring and regulatory labelling
• Quality experience including deviations, complaints, CAPAs, and root cause analysis
• Experience supporting regulatory change or improvement projects

Why Apply?

• Broad regulatory exposure across licensing, PI, and manufacturing
• High level of ownership and responsibility
• Opportunity to develop into a senior regulatory role
• Supportive, collaborative regulatory team environment

To apply or find out more, contact Rezaune Koopman for a confidential discussion.