Regulatory Affairs Manager
Oliver Care at CK Clinical is recruiting for a Regulatory Affairs Manager 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 be accountable for the quality and compliance of regulatory submissions, e.g. Clinical Trial Applications, scientific advice briefing packages, paediatric investigational plans and Marketing Authorisation Applications, for assigned products/projects.
- To assist in the communication with regulatory authorities and may be the contact point with regulatory authorities for specific proposed/pending regulatory submissions.
- To manage and co-ordinate requests for scientific advice with regulatory agencies in the EU and the preparation of briefing packages.
- To manage and co-ordinate the preparation, submission and negotiation of paediatric investigational plans.
Further responsibilities will include:
- Providing input to the clinical development and global regulatory strategic plans.
- Maintaining licences for marketed products if required.
- Supporting regulatory strategy and managing timelines and resources to meet project needs
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 the life sciences or a related field.
- Should have regulatory experience including some broader industry related experience.
- Should have extensive experience of IMPDs, submission of CTAs and the Regulatory Databases.
This is an excellent opportunity to join a global pharmaceutical company developing high quality products across the world and it also offers an attractive benefits package.
For more information or to apply for this position, please contact Oliver Care on 01438 842976 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 CL34861 in all correspondence.