Programme Manager Regulatory Affairs
Oliver Care at CK Clinical is recruiting for a Programme Manager Regulatory Affairs to join a company in the pharmaceutical industry at their site based in Hertfordshire on a permanent basis.
The main purpose of the role will be:
- To support or lead interactions with Health Authorities in the EU and other key countries. That will include the preparation/co-ordination of EU regulatory submissions (core CTA, scientific/qualification advice, PIP, registration documents, response to subsequent queries from Authorities).
- To coordinate and lead regulatory submissions and manage registration procedures for a new MAA in the EU, ensuring successful registration and acceptable labelling.
- To ensure Affiliates are informed of project developments and activities and work with the respective headquarters colleagues to provide responses to Regulatory questions from Affiliates.
Further responsibilities will include:
- Supporting staff in development of their knowledge and skills and offer further career opportunities locally and globally where people demonstrate talent and aptitude.
- Being highly motivated and committed with broad regulatory knowledge, experience and ability to manage complex issues with meticulous efficiency.
- Having a good level of experience in regulatory science and drug development.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Educated to University or higher degree in a scientific or technical discipline with in-depth experience within the oncology therapeutic area.
This is an excellent opportunity to join a company at the forefront of ground-breaking new medicines, consistently pushing the boundaries of conventional thinking and embracing innovation. Benefits include an annual bonus.
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.
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 CL33517 in all correspondence.