Description
World leading international Pharmaceutical client currently have a long term contract position for an experienced Regulatory Affairs Liaison.Under guidance of the Manager Regulatory Affairs Europe, you will be responsible for planning, collecting and preparing documentation used by regulatory agencies in the EU.
Responsibilities
-Draft Module 1 components and organise the gathering process of all those components for new filings and variations.
-Plan and coordinate variations (type I/II), and notifications etc for EU procedures.
-Arrange for timely submissions of the variation notifications/applications and responses in liaison with subsidiary registration managers when needed.
-Prepare the English product information (SmPC, labels, leaflets).
-During the procedures, draft response documents for EU related procedures.
-Provide support to Liaison during the entire registration procedure for new filings.
-Give regulatory input and guidance for the artwork development for the EMA.
Requirements
-University degree, preferably in a science related to medicine,
-Experience in the pharmaceutical industry.
-English is a must; other European languages an asset.
-Some knowledge of EU regulations and experience in RA is a must.
-Preference for local candidates or candidates highly motivated to relocate.
This is an exciting opening to work in dynamic team in a contract opportunity offering competitive rates of pay.