Associate Director Regulatory Affairs, Global Submission Coordination - Netherlands
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Associated Director Regulatory Affairs, Global Submission Coordination
- The department of Global Regulatory Affairs (GRA) is a dynamic internationally orientated environment with dedicated specialists responsible for the world-wide registration of the 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).
- GRA-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.
- 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.
- 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 advantage
- Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
- Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
- Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.
- To this end, we strive to create an environment of mutual respect, encouragement and teamwork.
- As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
A good place to work
- 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.
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