Вакансии

  • Киев
  • Полный рабочий день

Regulatory Manager

07 november 2018, 18:40

Regulatory Manager

Responsible for obtaining regulatory approval of new products, including drafting and execution of related regulatory strategies, and maintenance of product licences.

 

Duties:

Preparation of regulatory strategies for submission and approval of new product applications (MAA/NDA), management of submission teams, dossier compilation, responses to questions and negotiations with authorities

Regulatory maintenance of existing marketing authorisations for global products, including label and PIL management and regulatory compliance

Scientific advice,and other health authority meetings

Submission and approval of clinical trial applications (CTA) and IND's

Project team support, actively participating and representing GRAD in teams for development of new products/product extensions and drafting related regulatory strategies

Interdepartmental co-operation with active participation in collaborative meetings, e.g. lectures

Regulatory leadership, lead and coordinate regulatory submissions and related projects, motivate colleagues to ensure timely deliverables and high quality

 

 

Required Education/Qualifications/Skills:

  • Life Science or Pharmacy degree
  • 2- 5 years experience from Regulatory area
  • Understanding of GLP, GCP and GMP
  • Fluency in English

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