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Associate Director Regulatory Affairs, Global Submission Coordination Boxmeer Netherlands,  

Posted on : 09 June 2017

Project Description

Associate Director Regulatory Affairs, Global Submission Coordination-REG002795DescriptionAssociated Director Regulatory Affairs, Global Submission CoordinationIntroductionThe department of Global Regulatory Affairs (GRA) is a dynamic internationally orientated environment with dedicated specialists responsible for the world-wide registration of the MSD Animal Health range of products. The department forms the link between the global Research & Development organization and Regulatory Authorities in more than 100 countries. Its activities include the compilation of high-quality scientific dossiers for our products, co-ordination and support of the registration procedures and Pharmacovigilance. The department is embedded in the Global R&D organization and consists of cross-linked teams.Within GRA, the team of Global Licensing and Coordination (GRA-GLC) executes (in EU), coordinates, supports and maintains full oversight of- all licensing activities worldwide (except US).DescriptionGRA-GLC is looking for an Associated Director Regulatory Affairs to strengthen the team of global submission coordinators. Focus of this position is licensing coordination and can include other licensing tasks as appropriate.Key tasks " Coordinating the submission strategy of new R&D product dossiers and variations with global impact in close collaboration with other relevant GRA functions. " Projecting priorities and timelines from global perspective (R&D project team; product introduction team (PIT)) against country requirements (dossier plus national particulars) and expectations/planning from regional management for each new product submission. " Close collaboration with the regional RA coordinator in APAC, EURAM, and LATAM on key submissions, projects and business opportunities " Executing central and decentral European licensing procedures (new licensing/maintenance) " Establishing and upkeep contacts between our company and EU regulatory authorities. " Advising on regulatory requirements (all regions, except US) and contributing to the implementation of regulatory strategies to new product developments and existing product licenses. " Advising global R&D, global marketing, and country operations regulatory affairs (CORA) in the interpretation and application of veterinary legislation. " Manage data and information in an electronic environment, e.g. submission- and regulatory database management.QualificationsQualifications " PhD. (or MSc. + experience) in life sciences (Veterinary Medicines , Pharmacy or Biology) " Knowledge of research, production and/or control of veterinary products is an advantage. " Minimal of 4 years of experience in the licensing of pharmaceuticals and biologicals/vaccines (preferably for veterinary medicinal products) in EU and/or International regions. " Fluent in English in speaking and writing and preferably a thorough command of a second European language. " Team player and able to work with specialized international teams. " Able to analyze complex situations and find adequate solutions. " Experience in project management is an advantageAbout MSDMSD is working to help the world be well. Through our medicines, vaccines, biologic therapies and animal health products, we work in more than 140 countries to deliver innovative health solutions to patients and animals. We also demonstrate our commitment to increasing access to health care through far-reaching programs that donate and deliver our products to the people who need them. MSD has a workforce of almost 4500 in the Netherlands at three main sites.MSD. Be well. For more information, visit our website: Animal Health develops and produces vaccines and pharmaceutical specialties for livestock, companion animals and fish. We have offices in more than 50 countries, sell our products in over 140 markets and operate in a network of manufacturing sites and research and development facilities around the world. Within MSD Animal Health, we are always seeking innovative talents that focus on constant improvement of our products and the way we work. We re looking for new colleagues who are entrepreneurs and result driven. But not only results matter; how you achieve these results is crucial to be successful within MSD Animal Health as well. MSD Animal Health leads the way in veterinary pharmaceuticals.Our employees are the key to our company s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.A good place to workMSD is an attractive employer offering interesting opportunities in Research & Development, production and staff departments for an enormous range of disciplines such as biologists, chemists, process engineers, technicians, mechatronic engineers, pharmacists and operators. MSD always seeks best-in-class  employees at all levels. We expect a lot from our people and MSD has a lot to offer them as well. Team spirit, entrepreneurship, integrity, leadership and cross-border communication skills are what MSD values and rewards most. If you enjoy being challenged, over and over again, MSD will be a good place for you to work. We have an excellent fringe benefit program, and we invest heavily in the development of our people. MSD gives you plenty of opportunities for individual initiative and responsibility.ApplicationIf you are interested in this challenging role, you are requested to apply online by uploading your resume and application letter in English.Job: Regulatory Affairs Generic Job Title:Assoc. Dir, Regulatory AffairsPrimary Location: EMEA-Netherlands-NB-BoxmeerEmployee Status: RegularNumber of Openings: 1Company Trade Name:MSD Job Segment: Regulatory Affairs, Manager, Law, Pharmaceutical, Pharmacy, Legal, Management, Science, Healthcare


Boxmeer NL

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