Regulatory Affairs Expert (Part-time)

Medfiles Group in Lithuania is looking for an experienced local Regulatory Affairs Expert to assist pharmaceutical companies in several areas, such as product registration and maintenance activities, life-cycle management etc.

You can work at our office in Kaunas, or remotely.

Responsibilities:

• Working closely with global and local colleagues and assisting on matters related to regulatory affairs according to the legislation and project specific requirements.
• Acting as a local contact person for assigned responsibilities in specific client projects.
• Preparing and communicating strategic and operational plans for assigned projects.
• Maintaining and developing the applicable systems (document management, databases).
• Ensuring that all documents and information are captured correctly and in a timely manner in the applicable systems (document management systems and databases).
• Keeping up to date with external regulatory environments, new guidelines and legislation.
• Supporting and delivering quality regulatory submissions in line with the applicable regulations, directives and guidelines and the agreed strategies and timelines.

• A degree in life sciences or other relevant education.
• At least two years of experience in the Regulatory Affairs area whether with medicinal products (new MAA, variations, submission planning, PI & label updates) or in non-pharma area (food products, food supplements, medical devices, cosmetics etc).
• Knowledge of guidance documents, local legislation.
• Fluent language skills in Lithuanian and English.
• Precision and responsibility.
• Good computer skills.
• Good organization skills.
• Good project management, decision-making and negotiating skills.
• Teamwork skills.

In addition to the above, we also value:

• Experience in the Pharmacovigilance area.
• Medical education.
• Knowledge of the Russian language.

We offer

• Workload: Part-time (0,5-0,75 FTE).
• Contract: Temporary position with an estimated duration until end of February or March 2026, offering the potential for contract extension based on workload requirements.
• An international working environment.
• Comprehensive onboarding training.
• Chance to work in a friendly and supportive team.
• Wide range of employee benefits (incl. health insurance, additional vacation).
• Flexible working conditions.