Regulatory Affairs Manager
Oliver Care is recruiting for a Regulatory Affairs Manager to join a company in the pharmaceutical industry at their site based in Berkshire on a permanent basis.
The main purpose of the role will be to:
- Support UK Operations in the establishment and execution of robust regulatory plans for all relevant products and processes and ensure that submissions are made to the regulatory authorities in a timely and professional manner and in line with global regulatory strategy and local market needs.
- Work with global regulatory colleagues to prepare and submit responses to Regulatory Authority questions and develop and maintain SOPs to maximise local regulatory process and exceed the requirements of the group and Regulatory Authorities.
- Be actively involved in UK operations strategic planning, budgeting and business review process and participate in the review and approval of promotional materials, non-promotional materials, labelling and information items in line with the ABPI code of practice and UK statutory regulations.
Further responsibilities will include:
- Keeping up to date with the UK regulatory environment and develop/maintain strong working relationships with key medical, clinical, research and commercial colleagues in the UK and Ireland.
- Being responsible for effective communication on regulatory matters between cross functional groups and establish a relationship with the Regulatory Authorities. You will also take management responsibility for staff in the UK Regulatory Affairs Department.
- Managing packaging changes derived from variations, renewals and new MAs to comply with local requirements and manage the regulatory aspects of the automated packaging process. You will also manage the costs associated with regulatory process in line with budget.
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 extensive experience in a UK or European regulatory role and knowledge of the current EU/UK regulatory framework.
- A good understanding of the UK commercial and healthcare environment for medicines and an understanding of GxP requirements with previous people management experience and previous experience of managing a QMS and local complaints management.
- Excellent written and oral communication skills with ability to negotiate/influence as well as strong attention to detail and the ability to plan organise and coordinate multiple tasks effectively.
This is an excellent opportunity to join a global speciality-driven pharmaceutical company with innovative Research and Development and benefits include an annual bonus.
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 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 CL30674 in all correspondence.