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Technical Manager, Regulatory Affairs Development

Category	Regulatory Affairs
Job Ref	KO/HQ00014495
Job Type	Permanent
Salary	Salary on application
Location	Belgium

28 Aug 2010

Technical Manager, Regulatory Affairs Development.

Our Client, a major player of the pharmaceutical sector, is looking to recruit an experienced Regulatory Affairs Manager to strengthen their team in Brussels ( Brussels area)
.
In this role you will provide regulatory advice on strategy and manage projects in the provision of regulatory affairs services. You will liaise with internal and external clients in the provision and marketing of these services. You will also give advice and training to other regulatory affairs professionals and outside consultants as necessary. This position has no direct line management responsibility.

Duties and Responsibilities (according to relevant guidelines, laws and SOPs) .

-To provide project specific regulatory services and co-ordination of projects. .
-To provide regulatory strategy and product development advice to internal and external clients.
-To review and prepare regulatory submissions. .
-To manage project budgeting/forecasting. .
-To provide regulatory advisory and training service for regulatory affairs in the company. .
-Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines regarding clinical trials, regulatory documents and other regulatory submissions. .
-To manage other regulatory affairs individuals assigned to support projects of responsibility, as appropriate.
-To assist in business development and pricing of projects for Regulatory Affairs in the company.
-To deputize for the Associate Director / Director, Regulatory Affairs Development as necessary.
-Other duties as required.

Profile

•Bachelor's or higher graduate degree in a science related field with a suitable level of experience within a broad range of Regulatory Affairs projects, a good knowledge of global / regional Regulatory Affairs for clinical trials and marketing authorization procedures.
-Good in-depth knowledge in one of the specialist areas; preclinical, clinical, or CMC.
-Proven ability to work effectively in a team.
-Good knowledge of global / regional / national country requirements / Regulatory Affairs Procedures for Clinical Trial
-Authorization and Marketing Authorizations.
-Expert knowledge of ICH and other global regulatory guidelines.
-Good interpersonal skills are essential.
-Good organizational and planning skills.
-Must be able to work on own initiative.
-Able to manage and plan projects.

Interested? Please contact Karin Opdecamp +32 (0)10/233 707
belgium@hayspharma.com

For further information please contact
Belgium Jobs
Email: belgium@hayspharma.com

Services advertised by Hays Pharma are those of an Agency and/or an Employment Business