Regulatory Affairs Manager

Blackfield Associates; Slough; Hybrid; GBP 55,000 - 85,000; Full time

Job summary

An established industry player is seeking a Senior International Consultant in Regulatory Affairs to join their dynamic team. This pivotal role involves leading the preparation and submission of regulatory dossiers across EU markets, ensuring compliance with EMA and ICH standards. The ideal candidate will have a strong background in Regulatory Affairs, particularly with EU submissions, and will be responsible for conducting due diligence assessments and providing strategic guidance throughout the product lifecycle. This exciting opportunity offers hybrid working arrangements, allowing you to balance office presence with home flexibility while contributing to impactful projects in the pharmaceutical sector.

Qualifications

• 5+ years of experience in Regulatory Affairs within the pharmaceutical industry.
• Strong understanding of EU regulatory requirements and submission processes.

Responsibilities

• Lead the preparation and submission of marketing authorisation applications.
• Provide strategic regulatory guidance during product development and submission planning.

Skills

Regulatory Affairs

EU Submissions

Analytical Skills

Communication Skills

Detail-oriented

Education

Degree in Scientific Discipline

Tools

CTD Modules 1–5

Job description

2 weeks ago Be among the first 25 applicants

Direct message the job poster from Blackfield Associates

Senior International Consultant - Regulatory Affairs and Executive search

Blackfield Associates are supporting our client, a well-established generic and innovation pharmaceutical company based in Slough, in the search for a Regulatory Affairs Manager to join their expanding team. This is an exciting opportunity for a regulatory professional to play a pivotal role in the preparation, review, and strategic assessment of regulatory submissions across EU markets, particularly under the centralised procedure.

As Regulatory Affairs Manager, you will be responsible for:

• Review and Authoring of Modules 1–5 of regulatory dossiers in alignment with EMA and ICH requirements.
• Lead the preparation and submission of marketing authorisation applications via the Centralised Procedure.
• Conduct independent due diligence assessments for in-licensing or acquisition of new product dossiers – including new chemical entities (NCEs) and generics.
• Perform detailed evaluations of Phase III clinical study data and CMC sections of dossiers, identifying regulatory risks and mitigation strategies.
• Provide strategic regulatory guidance to cross-functional teams during product development, submission planning, and lifecycle management.
• Maintain up-to-date knowledge of EU regulatory requirements and changes in legislation impacting product development and marketing authorisation.
• Liaise with external partners, consultants, and Health Authorities as needed to support dossier development and submission activities.

To be considered for the role of Regulatory Affairs Manager, you will have the following:

• Proven experience in Regulatory Affairs within the pharmaceutical industry, with a strong focus on EU submissions, ideally minimum of 5 years.
• Direct experience with EMA and Centralised Procedures is essential - Experience with DCP and MRP pathways is advantageous.
• Strong working knowledge of CTD Modules 1–5, with demonstrable experience in authoring and reviewing content.
• Solid understanding of clinical trial data, particularly Phase III studies, and CMC documentation.
• Ability to independently perform regulatory due diligence for potential product acquisitions.
• Highly detail-oriented, with strong analytical and communication skills.
• Educated to Degree level in a scientific discipline.

This is a permanent role, hybrid working from the company's Slough based offices. Must be able to commute 3 days per week.

Unable to sponsor, all applicants must hold valid Right to Work status for the UK.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Quality Assurance and Other

Industries

• Pharmaceutical Manufacturing, Wholesale Drugs and Sundries, and Retail Pharmacies