Covance is looking to recruit Regulatory Specialist II to join our client team in the Baltics.

Essential Job Duties:

¨ Assist with the preparation of study documentation such as the core EudraCT Form and cover letter.

¨ Assist in the preparation of routine submissions filed to Regulatory Authorities

¨ Assist in the coordination, collection and organization of data and information required by

Regulatory Authorities.

¨ Interact with the Publishing group, Copy Center or equivalent as necessary for the production of submissions.

¨ Maintain an awareness of regulatory legislation, guidance and practice pertaining to drugs and biologics.

¨ Monitor compliance with regulatory requirements in relation to assigned projects.

¨ Work on special regulatory projects as assigned
Education/Qualifications:

• Bachelor's Degree in Life Sciences or equivalent

Experience:

• Proven experience in the Pharmaceutical industry, preferably in Regulatory Affairs or Drug Development