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 [email protected]