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 Buckinghamshire on a permanent basis.
The main purpose of the role will be to
- Provide operational support under supervision as well as regulatory guidance and strategy for global development projects mainly in the areas of cardiovascular and CNS and manage assigned regulatory submissions to obtain timely approvals of Clinical Trials Applications and Marketing Authorisations for a project portfolio spanning early to late phase development In Europe (and possibly outside of the EU).
- Lead the preparation of CTAs and amendments for assigned projects to obtain timely approvals from agencies and manage/ contribute to the regulatory activities associated with the registration and support of new drug products.
- Contribute to global internal strategy and guidance documents, support the development of strategies and advice in the development of pharmaceuticals and advise on submissions and submission planning
Further responsibilities will include:
- Preparing regulatory documents when required including IMPDs, amendments, TPPs, CCDS, PDPs, PIPs and reviewing RA documents for sign off prior to submission, evaluating the content of submissions and identifying inadequacies.
- Assisting in the preparation of responses to requests from regulatory authorities and may act as a liaison with the authorities to schedule meetings as well as liasing, negotiating and communicating with internal functional groups, corporate partners and affiliates relating to assigned products to obtain or provide information for submissions.
- Overseeing/managing CROs or external consultants involved in the submission of CTAs or any other RA activity on the company's behalf, design, review and interpret regulatory guidelines and SOPs and may travel to other offices and regulatory agencies outside of the UK when needed.
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/medical sciences or a related field with direct experience of Regulatory Affairs in the pharmaceutical industry in particular in drug development, managing CTAs (phase I-III) and MAAs in Europe.
- Working knowledge of Laws, regulations and guidelines is important and experience of working in a global regulatory environments and interacting with regulatory authorities is desired.
- Excellent interpersonal skills, detail orientated, well organised and self motivated with high ethical behaviour and excellent communication skills both written and verbal.
This is a great opportunity to work for a global Japanese pharmaceutical company with an exciting pipeline an benefits include an annual bonus and company pension.
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 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 CL31511 in all correspondence.