Description
This contract role is within the EU CMC group of an innovative pharmaceutical company in Cambridgeshire with a strong pipeline across multiple therapeutic areas.
The position itself involves:
- Preparation/coordination of submissions including support to major MAA filings
- Preparation of high quality CMC documentation based around original MAAs, variations and renewals
- Supporting Clinical Trial Applications for teams focused on specified therapeutic products
- Working closely with colleagues at manufacturing sites
The successful candidate will have:
- A minimum of four years of relevant experience within regulatory affairs
- CMC experience within EU markets
- A balance of clinical and post-approval CMC experience
- Excellent written and verbal communication skills
To be considered for this opening please submit your CV through the site or send directly to Andrew at (see below)
Allegis Group Limited and Aston Carter Limited operate Employment Businesses and Agencies and are companies within the Allegis Group Inc. group of companies, the fourth largest staffing company in the world, (collectively referred to as the "Allegis Group"). TEKsystems and Aerotek are divisions of Allegis Group Limited. Applicant data will be treated in accordance with the Allegis Group's Privacy Notice. By submitting personal data to any company or division within the Allegis Group, the applicant is providing explicit consent to the use of such data by the Allegis Group and to the transfer of such data to and from the Allegis Group companies within the UK, Europe and outside the European Economic Area in connection with the fulfilment of the applicant's voluntary requests, and the fulfilment of other job opportunities that match the applicant's profile, and confirms that they may be contacted about such job opportunities.