Regulatory Affairs Manager

CK Group are recruiting for a Regulatory Affairs Manager, to join a growing biotechnology company in Nottingham, on a permanent basis, with the flexibility of hybrid working. A great opportunity for an experienced Regulatory Affairs professional looking to make a step up to manager level and join an exciting new team.

The Company:

Outstanding biotechnology organisation focused on next-gen biopharmaceuticals, who have experienced tremendous growth in the last 3 years.

The Role:

To manage and coordinate regulatory activities, with overall responsibility for the company's regulatory documentation, regulatory strategy and customer support pertaining to regulatory issues.

Responsibilities:

- Overseeing the submission and maintenance of regulatory filings.
- Authoring product regulatory dossiers
- Presenting regulatory topics international conferences and meetings.
- Working with pharmaceutical organisations to influence regulators with regards to improving the
regulatory environment to support biopharmaceutical product innovation

Your Background:

- Degree or equivalent level qualification in life sciences. or other postgraduate qualification in
pharmaceuticals or regulatory affairs
- Regulatory affairs experience with pharmaceutical, biotechnology or biologic products (4 years plus).
- Knowledge of biotechnology process and product development, GMP requirements and global registration
procedures especially in the EU and US
- Experience in compilation of product information for regulatory dossiers (master files, product licence
applications and medical device registrations).

Benefits:

An attractive salary plus bonus (performance related), defined contribution pension, private healthcare, optional exercise classes/ social activities.

Apply:

Entitlement to work in the UK is essential. For more information or to apply for this position, please contact Naynesh Mistry on (phone number removed) or email (url removed). Please quote reference 53225