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3 found
T
Teva

Regulatory Affairs Associate

Regulatory Affairs Associate

Estonia, Tallinn

28.11.2021
T
Teva

Sales & Product Manager

Sales & Product Manager

Estonia, Tallinn

28.11.2021
T
Teva

Rx PM Market Access

Rx PM Market Access

Estonia, Tallinn

28.11.2021
Teva

Regulatory Affairs Associate

Estonia, Tallinn
Details


Teva in the Baltics:

  • 4 sites in 3 Baltic countries - manufacturing plant and 3 Sales & Marketing sites;
  • a team of almost 300 dedicated employees;
  • products delivered to >50 countries (mostly US, EU and Japan);
  • 8 times awarded as the Lithuanian Exporter of the Year by the Lithuanian Confederation of Industrialists

Regulatory Affairs Specialist

The key duty of the Regulatory Affairs specialist is to ensure that submissions and responses to Health Authorities are filed in timely manner and in compliance with the current regulatory requirements, as well as maintaining communication within company and local Health Authorities concerning issues related with regulatory affairs, product quality and/or product safety.

Key Responsibilities

  • Ensuring all submissions are in compliance with Health Authorities current requirements
  • Collection and proper archiving of documents intended for submission (new registrations, renewals and variations)
  • Keeping up to date internal data base
  • Proofreading of artworks (Estonian part of labeling)
  • Notification of advertising events, communication between the local office and PhV specialist of Teva Baltics
  • Handling of communication between the local Authorities, local office and QA manager of Teva Baltics concerning complaints or other with product quality related issues
  • Participation in advertisement materials release (in Zinc database)
  • Following all SOP’s and internal procedures applicable to RA specialist position
  • Complying with Teva Code of Conduct and high ethical standards
Qualifications
  • University degree ( pharmacist/biologist/chemist)
  • Good understanding of Estonian Regulatory Affairs market & related legislation
  • 2-3 years of experience in Regulatory Affairs
  • At least 2 years of working in a pharma/bio company
  • Fluent in business and medical English - verbal and in writing, fluent Estonian
  • Ability to work in dynamic environment, multi-tasking
  • Ability to work both individually and in the team, to cooperate on cross-country level and with different business units
What We Offer
  • work in vibrant international environment that encourages out of box thinking and innovation
  • professional development
  • healthcare insurance
  • employees initiatives
  • friendly atmosphere
  • fruit day once a week
  • work life balance
Regulatory Affairs
Sub Function
Medical Regulatory Affairs
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