Regional Regulatory Manager

The Pharmaceutical section of the Scientific & Regulatory Consulting Group provides a specialist service for clients requiring scientific consultancy advice and in document support for new product registrations & local MoH clinical trials submissions for new idications INDs, NDAs , Phases I, II, III, IV It is the role of the job holder to:

1. Contribute to the development of new and existing clinical projects such that agreed revenue targets can be met and spin-off work for other ESTERN Medical units is encouraged.Project (revenue) work will arise through repeat business, referrals from other colleagues (within and outside Regulatory Services) and from self-generated projects for products including conventional pharmaceuticals, biotechnology products and medical devices. The job-holder will be directly responsible for achieving revenue targets for this project work. The job-holder will be expected to prepare necessary project contracts/paperwork, show awareness on pricing and following-up on non-revenue project issues.
2. Actively demonstrate the potential to employ sales/business development skills to develop new clients for pharmaceutical consultancy work based on ESTERN Medical regulatory and scientific expertise.This role involves meeting clients largely through self-activity to explain ESTERN Medical consultancy and regulatory services, namely the provision of expert advice and the provision of regulatory documentation. Liaison with other areas within ESTERN Medical from which project work may arise (eg, Business Development, Toxicology Department, Programme Management and the Leeds Clinic) will also be involved. A degree of travel and/or presentations to clients and/or at meetings (internally and externally) are expected. The job-holder is also expected to show initiative in exploring other potential areas of revenue from existing clients and/or within on-going projects.
3. Process the results of project work by providing consultancy advice and/or regulatory documentation as well as liaising with the Regulatory Authorities (eg, FDA, EMEA, Local geographic specific EC/IRB’s & MoH’s- submissions in Latin America) on behalf of clients.Skills needed for processing project work will involve decision- and opinion-making through oral communication and written expert advice within a consultancy role and the ability to review regulatory and/or safety data and present an expert opinion both internally and externally. The job-holder will also need to prepare regulatory documentation (eg, Investigator’s Brochures, CTAs and relevant sections within INDs, NDAs, PMA’s, 510Ks), literature/safety data reviews and position papers. This latter role involves reviewing existing data as authorized by a client, provided by the client or from sources within ESTERN Medical and, where necessary, data from the public domain. Other aspects include peer-review of pre-clinical documentation prepared by other members of the department.
4. Provide expert regulatory advice to other ESTERN Medical departments.
5. Act as Programme Manager if required.
6. Comply with the requirements Quality Standards which may be required by ESTERN Medical