Regulatory Operations Associate
Julie at CK Group is recruiting for a Regulatory Operations Associate to join a company in the pharmaceutical industry at their site based in Uxbridge on a 6 month contract basis.
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 position comes with the flexibility to work at our clients site in either Uxbridge or Cambridge. The team are split between the two and minimal travel is required between the locations.
The Role: You will be working as part of a global Regulatory Operations team, both leading and contributing to global filings.
Duties include to:
- Lead key submissions for EU, CAN, MEAN and Emerging Markets. - Compilation and publishing of submission dossiers for clinical trials, paediatrics and marketing applications.
- Work closely with submission content providers to advise on submission content, structure, planning and strategy.
- Work with publishing vendors.
- Regulatory submission source document review, formatting & troubleshooting, including but not limited to, MS Office, Adobe Acrobat PDF, Acrobat Plug-ins and XML ensuring documents conform to style guide and internal/external regulations.
- Preparation of submission ready components from source documents according to regional regulatory agency guidance.
- Document management of ongoing submissions, e.g. building dossier structure, sourcing documents.
- Quality control of submission ready components and submission dossiers.
- Preparation, dispatch and tracking of electronic and paper media.
- Maintenance of submission information in Regulatory Registration Tracking system.
Your Background: To be considered for this role you should have the following skills, knowledge and experience:
- Bachelor's degree, or equivalent combination of education and experience.
- Specialist knowledge of pharmaceutical/biotech industry gained in operationally focused role.- Demonstrated experience with Insight Publisher including associated publishing, validation, and review tools.
- Experience of working with publishing vendors.
- Dossier and Submission related Regulatory Guidance for EU, MEAN and the Emerging Markets.
- Successful submission and maintenance of marketing applications in multiple regions.
For more information or to apply for this position, please contact Julie on 01438 768 710 or email email@example.com. 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 46757 in all correspondence.