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Job Description

Regulatory Affairs Specialist

We are currently seeking a Regulatory Affairs (RA) Specialist to join the team based in Vilnius, Lithuania. As a member of the RA team, you will be handling regulatory submissions for ancillary/raw/starting materials used in pharmaceutical applications and perform compliance activities in line with corporate and divisional objectives.

Key responsibilities:

• Collecting, consolidating and ensuring accuracy of documentation required for regulatory support in target market (EU, US, and other global markets).

• Creating and maintaining up to date product Master Files.

• Reviewing and approving product labeling and marketing information to assure compliance with the applicable requirements.

• Providing regulatory support and expertise to new product introduction project teams and different departments.

• Participating in change control activities by evaluating impact of manufacturing changes on technical documentation and submitting updates to the competent authorities.

• Developing regulatory affairs internal policies and procedures and providing trainings as and when required.

Requirements for qualification / education / experience:

• University degree in life sciences.

• Knowledge of laws and regulations in EU, US and other markets on registration of medicinal products. Understanding of QMS standards and GMP requirements.

• Experience in the pharmaceutical or medical device manufacturing company for over 3 years.

• Abilities to plan, organize and coordinate working process.

• Excellent English and Lithuanian language skills in verbal and written communication.

We offer:

• The innovative environment of the rapidly growing international company with encouraging working culture and outstanding development possibilities to increase your potential.

• An opportunity to work in a multifaceted global organization and collaborate with experienced professionals.

Compensation and Benefits

The salary range estimated for this position based in Lithuania is 2,625.00 EUR to 3,500.00 EUR.

At Thermo Fisher Scientific, each one of our 100,000+ extraordinary minds has an outstanding story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Compensation and Benefits

The salary range estimated for this position based in Lithuania is €31,500.00–€42,000.00.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.