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Job Details

Regulatory Affairs Manager / Benelux focus / Belgium or The Netherlands based

Company: Turner Regulatory
Location: Belgium or The Netherlands
Reference: 10099-1
Closing Date: 28 Feb 18
Type: Permanent
Salary (£): 60,000 - 80,000
Benefits: Bonus and good benefits

Job Summary:

Regulatory Manager; Benelux - Belgium, The Netherlands and Luxembourg based; local Affiliate Regulatory activity; Line and Project management; Registrations & post marketing

Requirements:

Superb opportunity for a Regulatory Affairs Manager/Project Manager or top-end Senior Regulatory Officer with a background in Regulatory Affairs within the Benelux Countries – The Netherlands, Belgium and Luxembourg

This highly successful Specialist Pharma Company with an expanding portfolio of Products, seeks a committed Regulatory Affairs professional with a positive attitude to take charge of day-to-day Regulatory Affairs in addition to supervising and mentoring Regulatory Staff. You will take charge of all Regulatory activities relating to Registrations and Post marketing of assigned Products within The Netherlands, Belgium and Luxembourg Affiliates

If you are a Regulatory Manager or perhaps a Project Manager/Senior Officer, possessing 4-6+ years in Netherlands, Belgium and Luxembourg Regulatory Affairs, this is the role for you. You will possess a good understanding and working knowledge of: CTD/Dossiers for MAA’s (Modules 1, 2 and 3); National Submissions/MRP, DCP and CP; Post marketing/Life-cycle management: Type Ia, Ib and II Variations and Renewals; Labelling, PIL's and SmPC's.

Regulatory Strategy, Tactics, Planning and Implementation. Impact Assessment. Regulatory subject matter expertise. Communication and excellent relations with appropriate local Regulatory Authorities. Ensure all Submissions are made in accordance with appropriate timings and requirements. Keep up-to-date with all appropriate Regulatory issues and operate as a ‘problem-solver’.

4-6+ years solid Netherlands, Belgium and Luxembourg Regulatory Affairs experience. Good working knowledge of Pharma Products. Project or Line Management experience is a distinct advantage.

An excellent salary package in offered, including €70,000-€85,000 basic - depending on experience, 15% bonus, and good benefits.

The role can be based in either Brussels (preferred), or Amsterdam.

If you are interested in this, or any other Regulatory Affairs roles, please get in touch with Julian Turner at Turner Regulatory Recruitment on +44 203 695 9477/+44 7447 977 330 or julian@turnerregulatory.com, or by clicking Apply Now.

Apply for this job: Regulatory Affairs Manager / Benelux focus / Belgium or The Netherlands based

Contact Information:

Address:  Head Office
71-75 Shelton Street
Covent Garden
WC2H 9JQ
England
Tel:  0203 695 9477
Website:  Visit Our Web Site

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