Regulatory Affairs Liaison

Job type:
on-site
Start:
ASAP
Duration:
6 months
From:
Generic Network
Place:
BE
Date:
12/01/2011
Country:
flag_no USA

Project description:
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Regulatory Affairs Liaison is require to provide strategy and assistance for assigned variations related to merger activities and initiatives to ensure registration data are both completely and properly presented so as to obtain timely approvals for the filed variations to ensure licenses for products are retained and up-to-date in Europe.

The regulatory affairs specialist will troubleshoot and resolve any problem on the critical path for product maintenance. Coordinates European subsidiary regulatory managers in the execution of regulatory strategies activities and thereby ensure timely approval

Role and Responsibilities:
. With guidance from the Director Regulatory Liaison - Europe, the incumbent coordinates and executes regulatory filings resulting from legal entity integration related changes for the products registered via one of the European registration procedures. Incumbent will cover scientific/strategic input and content review of such required regulatory filings.
. Incumbent will coordinate with RA-I Liaison personnel the timely completion of appropriate supporting documents to ensure consistency with European Union (EU) requirements.
. Maintains a sound scientific & regulatory knowledge and expertise within the field of CMC variations and in particular the new variation regulation requirements and current practices.
. Assists subsidiary personnel by providing scientific and strategic support, when necessary, permitting them to be more effective in negotiations with their respective agencies.

Experience:
. The experience in regulatory must include experience with preparing and filing variations (both administrative, CMC and clinical variations) within the European procedures- MRP/DCP and CP.
. Proven record of successful filings of variations according to the new variation legislation.
. Incumbent must have excellent communication skills (both oral and written), a working knowledge of personal computers, and be able to work effectively within a team environment.
. General competency, flexibility and negotiating skills are required. Fluent in English is a must.
. The incumbent must be available to work out from the Brussels office

If this is you please apply today,