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Regulatory Affairs Manager

  Dublin,  Ireland |  Full time

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Posting Date :  2021-08-31

Job Identification :  10880

Department  :  Regulatory Affairs

Reporting to the Head of Regulatory Affairs, the Regulatory Affairs Manager is responsible for the day to day Regulatory Affairs activities within the Regulatory Affairs Department.

Key Responsibilties;

  • Coordinate and manage all the Regulatory Affairs activities for Europe, Russia, CIS, Australia and New Zealand, ensuring all new applications, variations to existing licenses, renewals and other maintenance/defence tasks are executed in a timely manner.
  • Provide regular updates to Project Management and Senior Management in relation to the progress of all new applications and key maintenance/defence tasks.
  • Prepare, compile and submit new product applications through national, mutual recognition or decentralised procedures and also participate in assisting others in the department with such applications.
  • Liaise with the relevant stakeholders and guide the Regulatory Affairs Team during the preparation of responses to queries from regulatory agencies on new and existing products.
  • Ensure all relevant departments are made aware of changes in the registered details of all Bimeda licenses within his/her geographical jurisdiction.
  • Actively participate in EGGVP activities and keep up to date on information on any new legislation, guidelines or other relevant documentation associated to Regulatory Affairs.
  • Assist the Head of the Department during the preparation of annual budgets.

 

Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.

 

Other Requirements;

  • 10+ years’ experience within the Pharmaceutical or related industry, including 5+ years within a Regulatory Affairs function as Supervisor level or higher.
  • Previous experience in Animal Health companies desirable.
  • Post-graduate education in Pharmaceutical Technology and Regulatory Affairs desirable. 
  • Proficient in the use of MS Office tools  
  • Critical thinking and evaluation of process problems.
  • Excellent interpersonal and communication skills.

About Us

Bimeda is a leading global manufacturer,  marketer and distributor of animal health products and veterinary pharmaceuticals.  Through ongoing expansion and strategic acquisition,  Bimeda has established markets in more than seventy countries worldwide and has R&D,  manufacturing and distribution capabilities across Europe,  North America,  South America,  Africa,  Asia and Australasia.


global

OPERATES
IN OVER
75
countries

people

800+
EMPLOYEES

lab

6
R&D and
REGULATORY
LABS

factory

11
MANUFACTURING
facilities in
8 COUNTRIES

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