BD (Becton, Dickinson and Company) RA Manager - International in Eysins, Switzerland
Job Description Summary
An exciting opportunity to join the International Regulatory Affairs team of Becton Dickinson, a global leader in medical technology
You will join our International Regulatory Affairs team dedicated to our line of preoperative skin preparation solutions for Infection Prevention. This is a role creation as we need an RA manager to represent international requirements within the development core teams. This is a unique position in our organization, as BD’s products are mainly medical devices and ChloraPrep is the only product line that has pharmaceuticals specifities in terms of Regulatory Affairs.
You will be in charge of ensuring that international requirements are met through the development of new projects and providing regulatory support to international strategies and submissions. You will collaborate with the Infection Prevention team (international RA, R&D, manufacturing), mainly located in our European HQ in Switzerland as well as in the US.
As International RA Manager, you will be working closely with the Infection Prevention team (R&D, operations, RA international, local RA). You will be responsible for ensuring that the pharmaceutical products sold in international markets meet the local regulatory requirements and will support the local registration of these products in a professional, compliant and timely manner. You will provide timely support when requested by these organisations in preparing necessary registration documents, supporting timely submissions and maintaining an adequate archiving system.
You will liaise with the infection prevention team to make sure that existing regulatory requirements are known and controlled, and will then define the RA international needs, support RA and development strategies and establish priorities. Other key responsabilities include :
Maintaining the database in which all registrations made in international are documented
Reporting to your manager on the performance of the regulatory process system and development and registration timelines
Maintaining knowledge of specific regulatory requirements for targeted markets
When/if applicable, ensuring that sub-contracted distributors / laboratories / consultants are in accordance with the corporate quality and regulatory requirements.
You have a strong experience in regulatory in the pharmaceutical industry. You have supported diverse teams both in an international and in a development setting (marketing, R&D, operations…). As a result, you have a broad understanding of the impact of RA on the organization. Experience leading cross-functional project teams would be a plus.
Structured and self-organized, your strong planning, time management and prioritization skills are recognized, including your ability to multitask. An excellent communicator, you have strong negotiation and facilitation skills. You also have strong reasoning abilities and are skilled at defining problems, collecting data, establishing facts and drawing valid conclusions. Furthermore, you can interpret an extensive variety of technical instructions in mathematical or diagram form and can deal with several abstract and concrete variables. Other desirable features include :
Ability to analyze quality and regulatory documents (e.g. registration files and quality reports)
Ability to read professional journals, technical procedures or governmental regulations. Ability to write reports, registration modules and procedure manuals
Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public
Excellent spoken and written English (required)
For this role, you should be willing to travel up to 25% (mainly in the US).
Interested in a career with BD, but this position doesn’t fit your skills and experience? Join our external EMEA Talent Community here: http://bd.tal3nt.community/
Primary Work Location
CHE Eysins - Business Park Terre-Bonne
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.