Regulatory Affairs Director

3 days ago

Letchworth Garden City Hertfordshire, United Kingdom Cpl Life Sciences Full time

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. 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.

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.
Provide regulatory expertise on new product development.
University degree in a scientific subject.
Extensive experience in UK Regulatory Affairs
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
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.

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