Teva Regulatory Affairs Specialist 

Estonia, Tallinn 

200707431

We are currently looking for a Regulatory Affairs Associate in Tallinn whose main tasks will be to ensure that submissions and responses to Health Authorities are filed in timely manner and in compliance with the current regulatory requirements. Maintain communication within company and local Health Authorities concerning issues related with regulatory affairs, product quality and/or product safety.

• 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)
• 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
• Following all SOP’s and internal procedures applicable to RA specialist position
• Complying with Teva Code of Conduct and high ethical standards

• University degree (Pharmacist/Biologist/Chemist),
• Good understanding of Estonian Regulatory Affairs market & related legislation,
• 2-3 years of experience in Regulatory Affairs in the pharmaceutical industry,
• Fluent English and Estonian - verbal and in writing,
• 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.

• Rich benefits package: health and accident insurance, additional health and vacation days (for worked years);
• Highly professional Baltic level team and organizational culture with strong values;
• Personal and professional development within the company;
• Hybrid work model supporting work life balance;
• Employee rewards and recognition programs, events and social activities.
  

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