Darbo aprašymas

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

Your duties will include:

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.

Reikalavimai

A degree in life sciences or other relevant education.
At least two years of experience in 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 organisation and time management skills.
Good project management, decision-making and negotiating skills.
Teamwork skills.

In addition to the above, we also value: