Regulatory Affairs Professional for Pharmaceutical and Biotech Industries
1 month ago
We are seeking a highly skilled Regulatory Affairs Specialist III to join our Biosciences Division in Lithuania. This role will be responsible for planning, managing, and tracking regulatory submissions and documentation for raw materials used in the manufacturing of cell and gene therapies.
Key Responsibilities:- Support activities at Thermo Fisher Scientific sites located in Norway for bead-based technology products and processes.
- Act as a liaison between research scientists and cross-functional partners, including Regulatory Affairs, Quality Control, Manufacturing Sciences, Product Management, and IP Legal.
- Collect, consolidate, and ensure accuracy of documentation required for regulatory support in target markets (EU, US, and other global markets).
- Create and maintain up-to-date product technical documentation - Master Files.
- Review and approve product labeling and marketing information to ensure compliance with applicable requirements.
- Provide regulatory support and expertise to new product introduction project teams and departments.
- Participate in change control activities by evaluating the impact of manufacturing changes on technical documentation and submitting updates to competent authorities.
- Develop regulatory affairs internal policies and procedures, and provide training as needed.
- Handle confidential information appropriately.
Thermo Fisher Scientific is a rapidly growing international company offering an innovative work environment with excellent development opportunities. Our team consists of expert professionals who strive to make the world healthier, cleaner, and safer.
Requirements and Qualifications- University degree in life sciences.
- Familiarity with global Health Authority regulations and guidelines (e.g., FDA regulations, ICH, and EMA guidelines/directives).
- Understanding of QMS standards (ISO 9001, ISO 13485) and GMP requirements.
- Experience in regulatory affairs and/or pharmaceutical or medical device manufacturing for over 3 years.
- Able to plan, prioritize, and coordinate working processes independently and with minimal direction.
- Proficiency with computer programs/systems (MS Office, etc.) with demonstration ability to learn new systems quickly.
- Strong analytical skills and problem-solving abilities with the capacity to coordinate and work effectively with cross-functional teams.
- Will to travel 2-10% of the time.
The estimated salary range for this position in Lithuania is €31,500 - €42,000 per annum, commensurate with experience and qualifications.
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