Oliver Care is recruiting for a Regulatory Consultant to join a company in the pharmaceutical industry at their site based in Surrey on a permanent basis.
The main purpose of the role will be to
- Be responsible for a wide range of regulatory projects, playing a key role in establishing and maintaining good relationships woth clients and managing all activites relating to a particular client portfolio.
- Preparation of component modules of dossiers from clients data, preparation, submission, follow-up and maintenance of CTAs throughtout Europe and assistance with the preparation and submission of USA NDAs and INDs.
- Compilation of dossiers for and management of MR, DC and Centralised Procedures and the preparation and management of post approval submissions as well as preparing and managing the submission process for regulatory documents such as PIPs and Orphan Drug Designation applications.
Further responsibilities will include:
- Fulfil the regulatory function on project teams for clients, assist in the development of regulatory startegy for client projects and attend regulatory agency meetings on behalf of clients.
- Preparing proposals and management of project delivery to agreeed budgets including preparation of invoices.
- Provide assistance to company PIL user testing services as required, provide input into company processes and procedures, represent the company in a professional, positive manner and get involved in other aspects of the regulatory business as required.
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 a scientific discipline with significant experience in Regulatory affairs and a broad exposure to different areas this field as well as having a good understanding of the drug development process.
- Detailed knowledge of the European regulatory environment with working knowledge of the US or other regions globally and experience of interacting with regulatory agencies verbally and in writing.
- Broader industry experience desirable with excellent written and verbal communication skills and a highly professional manner.
This is an excellent opportunity to join an established company offering exciting career prospects.
For more information or to apply for this position, please contact Oliver Care on 01438 842 976 or 01738 743 047 or email email@example.com. 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 CL31038 in all correspondence.