CK Group is recruiting for a CMC Regulatory Affairs Manager to join a company in the Pharmaceutical industry at their site based in Uxbridge on a contract basis for 6 months and has a hourly rate of up to £56.
Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Our client has been a biotechnology pioneer since 1980. They have grown to be one of the world's leading independent biotechnology companies, reaching millions of patients around the world. Currently they are developing a pipeline of medicines with breakaway potential.
This position is based in at their Uxbridge site, which opened in 2007. Uxbridge is located in the heart of the biopharma community west of London. It is ideally situated for easy access to all that central London has to offer. Uxbridge also boasts a significant and growing business population and is conveniently located just 15 minutes from Heathrow Airport.
This position will play a key role in developing and executing CMC regulatory strategies for new marketing authorisation applications and throughout whole product lifecycle for the European and extended European region.
- Ensuring CMC regional issues impacting global regulatory strategy for proposed CMC filings are considered and risks identified with appropriate contingency strategies.
- Review the preparation of M2 and 3 CMC components of filings and assess fitness of purpose for submission in the relevant countries.
- Provide regulatory input on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, conditional/accelerated approvals, compassionate use and pediatric plan).
- Share regulatory information and implications with the stakeholders on an ongoing basis and provide advice on regional considerations.
- Provide guidance for regulatory assessments of change control requests.
To succeed in this role you will have excellent knowledge of CMC specific regulatory requirements within the pharmaceutical or biotechnology environments. You will have a strong background in a similar role and an understanding of drug development and the ability to create and execute regional regulatory strategies.
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 46869 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group
- Contact: Natasha Young
- Phone: 01246 457722
- Reference: 46869
- Posted: 24th October 2019
- Expires: 21st November 2019