Director Regulatory Affairs

Director Regulatory Affairs

Teva

Bucharest, Romania

Job Description:

Teva Pharmaceuticals is searching for qualified and motivated candidates for the role of Dirеctor Regulatory Affairs who has the responsibility of senior level of compliance, leading the Site Regulatory Affairs team and building relationship with internal and external stakeholders, by providing regulatory expertise on portfolio of generic products.

Main duties and responsibilities:

  • Effectively manage and coordinate all regulatory examinations with the Regional Head Site Regulatory Affairs and Site General Manager for the critical regulatory activities with impact on the approved/upcoming products;
  • Perform regulatory marketing authorization for European and international markets to support site;
  • Respond to regulatory inquiries from authorities that affect the assigned products or projects;
  • Manage the complaint process in connection with other local departments or with Site Regulatory Affairs departments from other sites;
  • Identify when required regulatory queries must be submitted to designated regulators and coordinate these filings in a timely manner;
  • Responsible for regulatory the dossier submissions, in order to reflect the latest regulatory status to the respective systems;
  • Responsible for employee recruitment and development, performance and rewards management, talent management;
  • Responsible for the site regulatory budget and team performance, KPI’s.

Other required competencies:

  • Leading, coaching and developing a high performing Regulatory Affairs team. Enables the team to manage the day to day activities due to proper training. Engages the team being a role-model leader;
  • Able to work as an active and influential member of a site leadership team who impacts across site functions;
  • Holds a broad perspective and understanding of the site business and processes and translates this into Regulatory Affairs terms.

The candidate should have:

  • Master degree in Management, Science or other relevant to the position;
  • Previous experience in pharmaceutical industry and regulatory affairs, preferably 5 years;
  • Very good communication skills in Romanian and English (both written and verbal);
  • Knowledge of addition European language would be considered as an advantage;
  • Must have an eye for detail and approach to work with good time management skills;
  • Able to prioritize and respond to internal and external regulatory authorities;
  • Able to work under pressure and on own initiative;
  • People management skills coaching and leading a team;
  • Familiar with Romanian and European regulatory law;
  • Experience with a cGMP and regulatory documentation;
  • Excellent computer literacy – MS Office (experience in the use of spread sheet and word-processing programs);
  • Experience with Trackwise and Document Management System.

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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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