CK Group are recruiting for a Regulatory Affairs Associate to join a company in the Pharmaceutical industry at their site based in Cambridge on a contract basis for 12 months initially.
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.
Located less than an hour away from London by train, the role will be based in Cambridge. Cambridge is one of Britain's most beautiful cities. Our client first established a presence on the Cambridge Science Park more than 25 years ago. Today, Cambridge still remains at the forefront of science and is one of Europe's most important biotechnology clusters.
Working within the Oncology TA, the Regulatory Affairs Associate under the direction of a Regional Regulatory Lead will assist in the creation and submission of regulatory documents for one or more assigned projects.
Key responsibilities include to:
• 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.
To be successful in this role you should have the following skills, knowledge and experience:
• Similar prior experience at an innovative pharmaceutical company, ideally with oncology experience.
• Strong communication skills - oral and written.
• Organizational skills.
• Understanding of drug development process.
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 KA44360 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group
- Contact: Lucy Stendall
- Phone: 01246 457733
- Reference: KA44360
- Posted: 9th January 2019
- Expires: 6th February 2019