BD (Becton, Dickinson and Company) Regulatory Manager EMA BD Life Sciences in Erembodegem, Belgium
Job Description Summary
Job locations: Erembodegem, Belgium or Le Pont-de-Claix (Grenoble area), France
As RA EMA Manager BD Life Sciences, you will report to the Director, Regulatory Affairs EMEA, BD Life Sciences.
You will be responsible for ensuring that the BD Life Sciences products sold in EMA (Eastern Europe, Middle East, Africa and CIS region) meet the local regulatory requirements and will support the local registration of these products in a professional, compliant and timely manner. Hereto, you will develop strong working relationships with the EMA regional RA and commercial business teams. Together with your RA EMA BD Life Sciences team, you will provide timely support when requested by these EMA regional organizations in preparing necessary registration documents, supporting timely submissions and maintaining an adequate archiving system.
Main responsibilities include, but are not limited to:
Support the implementation of the EMA Business strategies for the Business Unit (BU);
Work closely with the RA EU Manager to develop and support the Regulatory Strategy for BD Life Sciences in EMEA;
Assess regulatory impact of projects lead by the manufacturer or EMA business, communicate the regulatory impact to the EMA BU or manufacturer and implement all regulatory activities needed to ensure regulatory compliance;
Participate in Business meetings and represent EMA RA as a partner/supporting function for BD Life Sciences teams in EMA;
Create comprehensive metrics to report to the EMA organisation on progress of product registrations in targeted markets and communicate clearly with the appropriate stakeholders;
Work closely with the RA planner EMA to prioritise, organize and plan RA activities and workload of available resources;
Manage and lead the EMA BU RA team to provide RA support to BD Life Sciences activities in EMA:
Identify training needs for the EMA BU RA team members and develop a regulatory training program for the EMA regulatory affairs team. Manage training records for applicable corporate and departmental procedures included in the training program;
Develop and increase efficiency of the regulatory processes to support new product launches;
Develop and increase efficiency of the regulatory processes to assess impact of changes to products on product registrations in the EMA region;
Maintain the EMA Registration databases;
Maintain knowledge of specific regulatory requirements for targeted markets in EMA;
Report on the performance of the regulatory processes and registration timelines; and
Assist in the development, review and implementing regional policies and procedures based on corporate and regional requirements.
More about yourself:
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 and solving 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 skills 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.
Ability to effectively present information and respond to questions from managers
Ability to work in an international environment
Good people leadership, development and coaching skills.
Travel: International travel up to 25%
Education: Related degree level education required. Higher education is a plus.
Licenses/Certifications: Industry/function specific certification preferred.
Experience: 3-4 years or more related industry (e.g. life sciences) experience preferred.
Competencies: Native level English proficiency, both written and verbal. Additional European language is a plus. Computer literate.
If this describes you and your career aspirations, then please click on the APPLY button.
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
BEL Erembodegem - Dorp 86
FRA Le Pont-de-Claix Cedex
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.