Regulatory Affairs Associate

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

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.

What you will be doing

• 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

Contacts / CooperationWithin the company:

• Head of Regulatory Affairs department Teva Baltics
• Country manager Teva Estonia
• Regulatory Affairs Specialist, Estonia
• Regulatory Affairs teams, Latvia, Lithuania
• Other Teva Estonia employees
• Other Teva Baltics employees
• Teva Europe RA teams (Procedures coordinators)

Outside the company:

• Health Authorities

• 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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