Shreeya Patel at CK Clinical is currently looking for an Emerging Markets Regulatory Affairs professional to join a global pharmaceutical company at their site based in the South East UK. This Pharmaceutical Regulatory Affairs position is a contract position.
About this Regulatory Affairs Contract Role:
As an Emerging Markets Pharmaceutical Regulatory Affairs contractor you will create the CMC sections of Emerging Market initial submissions for established and/or new products and pass to the Product Strategist by the required date.
You will also respond to CMC-related questions as part of the project team, by the required date and to use established systems (particularly web-based document management systems) to ensure global transparency of submitted and approved documentation.
Qualifications, Skills and Experience:
To be considered for this Regulatory Affairs position, you will have the following qualifications, skills and experience:
- Demonstrable Regulatory Affairs experience in European and/or global market primary applications
- A broad understanding of European legislation and both technical and procedural guidance; ICH CTD; applicable Module 3 guidance; and variations legislation and guidance at a European and/or global level.
- Good IT skills including use of Documentum based document management systems.
- You will be a team player, with strong communication and negotiation skills
- You will have the ability to work independently and to build strategic working relationships
How to apply:
For more information regarding this Pharmaceutical Reg Affairs contract position, please contact Shreeya Patel at CK Clinical on +44 (0)1438 743 047 or email firstname.lastname@example.org. Please quote reference CL24497 in all correspondence.