A rapidly growing CRO based in the Thames Valley is seeking to expand its Regulatory Affairs team and wishes to recruit an experienced Senior Regulatory Affairs Associate
The ideal candidate will have a strong Clinical Research base and should have a passion for the |Life Sciences industry. The role has a well-defined commercial focus across multiple therapeutic areas.
- Managing clinical trial applications of both new and pre-existing pharmaceuticals
- Ensuring all applications are carried out in collaboration with ICH guidelines and the Clinical Trial Directives.
- Ensuring submissions are taken care of within a pre-established deadline and that all stakeholders are informed of each part of the project.
- Work with internal & external customers to provide data and accurate regulatory input
- Communicate with regulatory agencies and document communication
- Prepare, Review and sign off change control risk assessments
- Prepare & review assigned SOPs
- Review and approval of CTA/IND submission and maintenance documentation
- Regulatory Authority commitments, quality and safety reviews
- Review updates to the regulatory environment and suggest impacts
To be eligible for this role, you must also have Regulatory Affairs experience as Associate or above with Clinical Trial Experience on a Global Scale. In addition, you will need:
- Relevant life sciences degree
- Minimum of 3-5 years in the pharmaceutical field
- Demonstrated ability to write good quality documents
- Communication skills
- Attention to detail/accuracy
- Project management skills
The successful candidate will receive a competitive salary along with a flexible working day and many other benefits commensurate with a forward looking company.
Elevate Pharma is a specialist Life Sciences Recruiter and this vacancy is just one of a number of positions that we currently have available in this sector.