Regulatory Affairs Manager
Oliver Care is recruiting for a Regulatory Affairs Manager to join a company in the pharmaceutical industry at their site based in the Home Counties on a permanent basis.
The main purpose of your role as Regulatory Affairs Manager will be to:
- Manage assigned EU regulatory submissions to obtain timely approvals of CTAs and MAAs for a project portfolio spanning early to late phase development.
- Advise and Inform on submission planning and ensure submission tracking and QC check of documents. Ensure high quality regulatory documents.
- Lead and manage the preparation and submission of CTAs and amendments in early to late phase oncology projects. Prepare gap analysis of clinical/technical documentation Vs regional and global requirements.
Further responsibilities will include:
- Supporting the development of strategies and advice in the development of pharmaceuticals, advising on submissions and evaluating the content and preparing regulatory documents for submission when required.
- Liaising, negotiating and communicating with functional groups within the company, corporate partners, affiliates and authorities and oversee and manage CROs/external consultants.
- Designing, reviewing and interpreting regulatory guidelines and SOPs in line with current European guidelines,
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- A bachelor's degree or higher in life science or related field with experience in the pharmaceutical industry and considerable experience in Regulatory Affairs with an emphasis on drug development and CTAs phase 1-3.
- Experience within the Oncology therapeutic area.
- Working knowledge of laws, regulations and guidelines with excellent interpersonal skills.
For more information or to apply for this position, please contact Oliver Care on 01438 743047 or email email@example.com. Alternatively, please click on the link below to apply online now.
CK Clinical 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 CL29392 in all correspondence.