Regulatory Program Manager- Oncology
Oliver Care is recruiting for a Regulatory Program Manager - Oncology to join a company in the pharmaceutical industry at their site based in Hertfordshire or Basel on a permanent basis.
The main purpose of the role will be to:
- Working independently as well as within a regulatory sub-team in a global development team, participate and if necessary represent Regulatory Affairs on cross-functional teams in early and/or late stage project teams.
- Provide strategic regulatory input to project teams throughout the drug development process and its lifecycle.
- Give specific guidance to project teams/functions on regulatory issues such as legislation, guidelines and procedures etc.
Further responsibilities will include:
- Take the lead in interactions with Health Authorities in the EU and other key countries.
- Prepare registration documents for MAA/variations and core dossier for CTAs.
- Coordinate regulatory submissions and manage registration procedures for new MAA and/or variations in the EU, ensuring successful registration and acceptable labelling. You may also support registration procedures outside of the EU.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Educated to degree level in a scientific or technical discipline with demonstrable experience in a similar role in the EU area e.g. successfully managing regulatory procedures and interaction with Health Authorities.
- Experience within the Oncology therapeutic area is ideal or Haematology and Haemophilia a disease area as well as a good understanding of drug discovery and development especially clinical aspects.
- Highly motivated and committed with strong leadership competencies and exceptional communication skills and fluency in written and spoken English.
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.
For more information or to apply for this position, please contact Oliver Care on 01438 743047 or email firstname.lastname@example.org. 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 CL30539 in all correspondence.