Associate Regulatory Affairs
CK Group are recruiting for an Associate Regulatory Affairs to join a biopharmaceutical company based either from home or at their site based in Uxbridge on a contract basis for 12 months.
Company: Our client is committed to unlocking the potential of biology for patients
Associate Regulatory Affairs Role:
- The Regulatory Professional under the direction of a Regional Regulatory Lead will assist in the creation and submission of regulatory documents mostly related to clinical trialsin the EU.
- Ensure compliance via timely submissions to regulatory agencies.
- Coordinate collection of functional documents in support of regulatory applications. Coordinate QC of regulatory documentation (e.g. briefing packages).
- Prepare regulatory packages and cross-reference letters to support investigator initiated studies.
- Complete regulatory forms to support agency communications (e.g. EudraCT).
- Good communication skills - oral and written.
- Organizational skills.
- Understanding of drug development process.
- Previous experience in pharmaceutical industry of at least 1 year is preferred in a regulatory affairs department.
Apply: For more information or to apply for this Associate Regulatory Affairs position, please contact Lucy or Andy on 01246 457725 or email firstname.lastname@example.org, quoting job ref 48735.
It is essential that applicants hold entitlement to work in the UK.