Brandon Whates is recruiting for a Regulatory Affairs Manager to join a global biopharmaceutical company that strive to enhance lives and quality of life at their site based in Surrey. The role is a permanent position working on an orphan drug used in the treatment of pigmentation disorders and the prevention of further skin conditions through photomedicines. They currently have one product on the market and two further formulations in preclinical development.
The main purpose of the role will be to:
- Prepare documentation to support marketing authorisation applications and prepare post authorisation regulatory documentation and applications, including market access and ethics committee applications.
- Assist in the development of the ongoing global regulatory strategy and assist in the preparation and review of briefing documents to support meetings with the relevant regulatory bodies.
- Submit marketing authorisation applications and variations and prepare response to questions raised by competent regulatory agencies.
Further responsibilities will include:
- Preparing and/or collating all documentation to support clinical trial applications in Europe, file substantial amendments as required and submit applications to ethics committees.
- Preparing response to questions raised by ethics committees and updating documentation as required as well as maintaining the Investigator Brochure and Investigational Medicinal Product Dossier.
- Create country specific secondary packaging material and obtain approvals on labelling text and design by competent authorities.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Educated to degree level or above in life science or a related field with pharmaceutical industry experience in a Senior Regulatory Affairs role.
- Experience of preparing EU marketing authorisation applications, managing centrally approved products, preparing CTAs to support clinical trials and exposure to orphan drug requirements.
- Excellent communication, relationship building and project management skills.
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 41834 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group
- Contact: Brandon Whates
- Phone: 01438 743047
- Reference: 41834
- Posted: 27th February 2019
- Expires: 27th March 2019