Senior Associate Regulatory Affairs
CK Group is recruiting for a Senior Associate Regulatory Affairs to join a company in the Pharmaceutical industry at their site based in Cambridge on a contract basis for 12 months and has a hourly rate of £19.06 PAYE.
The Company: 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.
The Location: This role can be based in either Uxbridge or Cambridge. The Cambridge office is situated about 3 km to the north of the historic and picturesque city of Cambridge. This location is easily accessible by car, train or by bus.
The Uxbridge site, which opened in 2007, 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.
- Assist Regional Regulatory Lead to support regional regulatory filing activities (e.g. core CTA/IMPD development and submission).
- Provide and maintain CTA/MA documentation (e.g. variations, substantial amendments, PDCO annual reports) in collaboration with Regional Regulatory Lead.
- Coordinate collection of functional documents in support of regulatory applications.
- Prepare regulatory packages and cross-reference letters to support investigator sponsored studies.
- Actively support regulatory compliance, and ensure compliance via timely submissions to regulatory agencies.
- Create and maintain product regulatory history documents through company systems and appropriately archive all regulatory documents and agency communications.
- As appropriate may participate in GRT to support execution of regulatory strategy.
- Respond to specific requests from and communicate relevant issues to GRT.
- Support the development and execution of GRT goals.
- Review regional component of the Global Regulatory Plan and provide input to operational deliverables.
- May support RRL in review of promotional materials for commercial activities.
- Provide regulatory support to Commercial, Medical and Clinical departments through cross-functional interactions in brand and therapeutic area teams.
- Support process improvement initiatives, standards development, and metrics.
- Previous regulatory experience.
- Strong communication skills - oral and written.
- Organizational skills.
- Understanding of drug development process.
- The ability to work from the office in either Uxbridge or Cambridge.
For more information or to apply for this position, please contact Lucy or Julie on 01246 457725or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. 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 47410 in all correspondence.