Senior Regulatory Program Manager
Mary Tilston at CK Clinical is recruiting for a Senior Regulatory Program Manager to join a company in the pharmaceutical industry at their site based in Hertfordshire on a contract basis.
The main purpose of the role will be:
- To work independently within the therapy area( immunology, Infectious diseases, Ophthalmology & Neuroscience)
- To work on Health Authority meeting preparations, briefing packs and support the clinical study teams within the regulatory teams.
- To represent the regional function on cross functional teams (e.g. Global Development Teams/Life cycle teams/Disease Biology Project Teams).
Further responsibilities will include:
- To analyse the regulatory environment for impact of project/plans and briefs team/management as appropriate.
- Provide guidance on regulatory issues such as legislation, guidelines, and procedures to the respective teams.
- Planning, leading and implementing regulatory submissions (MAAs, CTAs, local submissions, etc.) in collaboration with the other disciplines (eg., Affiliates, PDR emerging markets and regional Affiliates) .
- Manage and co-ordinate the regional registration procedures.
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 life science or a related field.
- Significant previous experience in Regulatory Affairs including involvement with Health Authority meetings (including FDA) as well as clinical development and phase II study knowledge.
- Must have excellent knowledge of regional regulatory processes and proven experience of successful management.
- Must have practical experience of successfully managing Health Authority interactions on a regional basis.
For more information or to apply for this position, please contact Mary Tilston 01438 768717 or email firstname.lastname@example.org. 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 CL35088 in all correspondence.