Regulatory Affairs Associate
Mary Tilston at CK Clinical is recruiting for a Regulatory Affairs Associate to join a company in the Pharmaceutical industry at their site based in Central London on a contract basis.
The main purpose of the role will be to:
- Assist in the oversight and coordination of all regulatory activities within the Organisation and ensure that all the clinical trial applications and other clinical development activities meet current regulatory requirements/guidelines both in the EU and the US.
- Be responsible for the operational, quality and administrative aspects of Regulatory Affairs as instructed by the Head of Regulatory Affairs, ensuring that internal and regulatory timelines are met.
- Compilation of core regulatory packages for use in EU clinical trial applications (CTAs) and compile complete CTAs for submission to UK and IE Competent Authorities.
Further responsibilities will include:
- Providing oversight of Service Providers making CTA submissions, ensuring that the filing of clinical trials documentation is kept up to date and compliant and coordinating and tracking responses from competent authorities.
- Assisting with the compilation of Investigational New Drug (IND) application documentation for submission to the US FDA and track and coordinate IND annual reports.
- Representing Regulatory Affairs at study team meetings, attending relevant internal/external meetings and reviewing/auditing CRO reporting and procedures as and when appropriate.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Educated to degree level or above in life sciences or a related field with strong experience within regulatory affairs in a CRO, pharmaceutical, or Biotechnology Company.
- A good understanding of GCP and clinical trials application processes in the UK is essential with the ability to handle multiple tasks to meet deadlines.
- Excellent communication skills with the ability to interact effectively at all levels including external partners and clients.
This is an excellent opportunity to join a global speciality pharmaceutical company.
For more information or to apply for this position, please contact Mary Tilston on 01438 768717 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online.
CK Clinical is an Equal Opportunities employer who 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 CL34564 in all correspondence.