BrightOwl Loader Loading

Associate Director Regulatory Affairs, Global Submission Coordination Boxmeer Netherlands,  

MSD (company)

Posted on : 09 June 2017

Project Description

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.

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.

  • 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

About Us:
  • 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.

Job Segment:  Regulatory Affairs, Manager, Law, Pharmaceutical, Pharmacy, Legal, Management, Science, Healthcare                       


Boxmeer NL

Find a Job Find Candidates

Similar Jobs

More jobs from MSD

Other jobs in Netherlands

Other jobs in Boxmeer

Other jobs from MSD in Boxmeer

Other similar job in Boxmeer

Other Jobs

Most Recent Searches

Most Famous Searches

You might also like