Regulatory Program Manager in Hertfordshire
Mary Bolt is recruiting for a Regulatory Program Manager to join a research-focused healthcare company at their site based in Hertfordshire on a permanent basis.
Our client is a global pharmaceutical company providing an innovative range of diagnostic solutions and medicines.
The role is based at our client's site in Hertfordshire which is commutable from many towns from Middlesex to Cambridgeshire. There are good road and public transport networks and London is easily reachable. Hertfordshire boasts many landmarks as well as beautiful countryside.
Your main duties will be to:
Be responsible for regional (EU, ROW) regulatory strategic and operational management of a project, or part of a complex project, or a portfolio of projects as well as the development and implementation of regional regulatory strategies on projects.
Give regional strategic regulatory input for the lifecycle management of products, throughout the development and lifecycle value chain and provide regulatory strategic recommendations concerning acceptable labelling in regional markets, in collaboration with relevant functions.
- Represent and/or support the Regulatory Leader in representing the regional function on cross-functional teams (e.g., Global Development Teams/ Lifecycle Teams/Disease Biology Project Teams).
Further responsibilities will include:
- Taking the lead in the interaction with regional regulatory agencies during product development and lifecycle management; in collaboration with EU affiliates and taking the lead via the Key Country affiliates for Key Country Agencies.
- Being responsible for planning, leading and implementing regulatory submissions (MAAs, CTAs, local submissions, etc.) in collaboration with the other disciplines.
- Managing and co-ordinating the regional registration procedures as well as the preparation of the answers to questions from authorities and subsidiaries.
The ideal candidate for this role will:
- Be educated to degree level or above in life science or a related field with significant experience in Regulatory Affairs in the pharmaceutical industry.
- Have knowledge and experience of regional regulatory processes (e.g. successful management of Centralised/Mutual Recognition Procedure in the EU) and practical experience of successfully managing Health Authority interactions on a Regional Basis (EMEA/ CHMP and National Authorities, or Key Countries).
- Have excellent communication, influencing and interpersonal skills as well as leadership skills and the ability to work effectively to share responsibility as a team member.
For more information or to apply for this position, please contact Mary Bolt on 01438 768717 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group 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 45843 in all correspondence.