Regional Clinical Trials Regulatory Manager
EM-R-CT -R-M – 1001
*Mexico / *Chile / *Colombia / *Argentina / *Brazil.
General Purpose and Scope
- To provide an expert scientific consultancy and regulatory service to clients for pharmaceuticals and related areas by assisting with identifying and processing potential sources of business into projects with revenue.
- Specific skills for this job holder include the ability to work on various assignments simultaneously, with no direct supervision as well as providing a “stand-alone” expertise which has a vital input towards the budget of the group.
- To be directly responsible for achieving agreed revenue targets for assigned project work and thus have a direct impact on the revenues of the group.
- To assist in developing new and supporting existing client relationships and acquiring revenue-earning projects.
- To review and critically assess regulatory and/or safety data and provide expert advice and guidance both internally and externally.
- To take decisions and make opinions on scientific and regulatory issues and provide strategic comments within sponsored projects and to communicate these orally and in writing to the client.
- To organize and manage regulatory documentation, literature/safety data reviews and position papers.
- To liaise directly with personnel within ESTERN Medical and other ESTERN Medical Business Units to successfully maintain and generate revenue-earning projects.
- To co-operate with ESTERN Medical personnel, external clients and regulatory authorities in order to support the provision of the necessary documentation and services to the required standard and in a timely fashion.
- To maintain expertise in appropriate scientific disciplines through participation in relevant scientific and regulatory meetings.
- Assist in the training of junior staff within the group.
- To comply with Quality Standards which may be required by ESTERN Medical.
Specific Duties and Responsabilities
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:
- 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.
- 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.
- 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.
- Provide expert regulatory advice to other ESTERN Medical departments.
- Act as Programme Manager if required.
- Comply with the requirements Quality Standards which may be required by ESTERN Medical
Primarily, external contacts will be with new or existing clients and staff from regulatory agencies. Internal contacts will include the Head of Regulatory Affairs, to discuss projects and future work within the Scientific & Regulatory Consulting group, Business Development, Toxicology Department, Programme Management and the Leeds Clinic. Contact with other areas within ESTERN Medical with a need for consultancy/regulatory services will also be expected. Business opportunities and workload will be discussed at regular in-house group meetings.
In order to fulfill the role of Regulatory Manager, the job-holder must maintain an up to date knowledge of developing regulatory/registration requirements within Latin America (Mexico, Colombia, Chile, Argentina, Peru and Brazil) EU, and USA. Travel Required 10-15%
Education / Experience / Skills
- Educated to at least BSc level in a relevant life-science subject.
- Previous experience (approx. 7 years) in preclinical drug development gained within industry, academia or contract research or approx. 5 years experience gained in a similar role.
- Excellent communication skills (written and oral).
- Proven ability to demonstrate communication/interpersonal skills necessary for client contact and the potential to develop in sales/business development.
- Excellent planning and organizational skills. full knowledge computer skills.
- Proficient full English & Spanish written & verbal