UK Regulatory Affairs Manager

Cpl Life Sciences; Letchworth; On-site; GBP 65,000 - 75,000; Full time

Job summary

A leading pharmaceutical business in the UK seeks a Regulatory Affairs Manager/Snr Manager to manage the UK product portfolio and ensure compliance with regulatory requirements. The role involves strategic planning and submission management in a rapidly evolving environment. Ideal candidates will have extensive UK regulatory affairs experience and excellent documentation skills. This position offers a competitive salary and an attractive benefits package, including private healthcare and a flexible benefits scheme.

Benefits

Defined-contribution pension scheme

Share ownership scheme

Private healthcare

Life assurance

Flexible benefits scheme

Qualifications

• 5+ years of prior UK-related RA experience.
• Proven experience managing UK submissions post-Brexit.
• In-depth knowledge of UK and EU regulatory requirements.

Responsibilities

• Support regulatory requirements for Clinical Trial Applications.
• Lead interactions with the MHRA for strategic advice.
• Drive UK regulatory strategy for developing drugs.

Skills

UK Regulatory Affairs expertise

Strategic and technical advice

Documentation skills

Mentoring and relationship management

Education

University degree in a scientific subject

Job description

Job Title: Regulatory Affairs Manager / Snr Manager - UK Market

Location: Hertfordshire, UK – Hybrid, 3x a week on site

Job Type: Permanent Position

Remuneration: £65,000 - £75,000 + Car Allowance + Bonus

This is an excellent opportunity to join a leading pharmaceutical business. In this position, you will be responsible for all aspects of the UK product portfolio for developing drugs and established products. You will work as a subject matter expert within the UK affiliates and support both new registrations and lifecycle maintenance.

The Regulatory group works with the wider business to translate the constantly evolving requirements of the UK Regulatory environment into the business's policies, procedures, solutions and strategies that ensure compliance and maximise the value for patients.

Role responsibilities

• Support the team in ensuring that regulatory requirements are met for Clinical Trial Applications.
• Lead all interactions with the MHRA, including Scientific Advice, PIPS, and pre-submission meetings.
• Drive end-to-end UK regulatory strategy for innovative developing drugs.
• Clinical Trial Applications, National Licensing Applications, Early Access to Medicines Applications, and National components of medicines authorisation via the European Centralised procedure.
• Support the teams in any interaction with the MHRA.
• Provide regulatory expertise on new product development.
• Support MAA's filling into the UK market.

Requirements

• University degree in a scientific subject.
• At least 5 years of prior UK-related RA experience.
• Extensive experience in UK Regulatory Affairs
• Proven experience managing UK submissions post-Brexit
• Experience providing strategic and technical advice
• In-depth knowledge and experience of UK and EU regulatory requirements and procedures
• A proven track record of developing, implementing, and communicating regulatory strategies
• Excellent documentation skills to ensure high-quality and timely submissions
• Experience as a Subject Matter Expert (SME) in defined subject areas or therapeutic areas
• Experience in mentoring peers, as well as managing stakeholder relationships

Due to the organisation's rapid growth, there is extensive opportunity to grow and develop within the company. In addition to a competitive salary, the organisation offers a highly attractive benefits package that includes a defined-contribution pension scheme, a share ownership scheme, private healthcare, life assurance, and a flexible benefits scheme that you can tailor to your own requirements.

If you are interested in this role or would like more details, please email your CV to [e-mail]