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Job Details

Regulatory Affairs Manager / Life-cycle, Europe - Flexible Working

Company: Turner Regulatory
Location: Middlesex
Reference: 10098-1
Closing Date: 28 Feb 18
Type: Permanent
Salary (£): On Application
Benefits: Bonus and good benefits

Job Summary:

Regulatory Affairs Manager; Life-cycle Management; Project Managing & Leading; Europe and Australia/New Zealand focus; mentor and supervise staff


Flexible Working arrangments!!

Outstanding opportunity for a Regulatory Affairs Manager/Project Manager or top-end Senior Regulatory Officer with a background in Regulatory Life-cycle management within Western Europe and ideally Australia/New Zealand!!

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 Life-cycle management in addition to supervising and mentoring junior Regulatory Staff. Project Management and Leading experience required.

If you are a Regulatory Manager or perhaps a Project Manager and Senior Officer, possessing 4-6+ years in European and some International 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. Life-cycle subject matter expertise. Communication and excellent relations with appropriate 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 European Regulatory Affairs experience, good experience in Australian and New Zealand Submissions a distinct advantage. Good working knowledge of Pharma Products. Project or Line Management an advantage.

An excellent salary package in offered, including £50,000 to £65,000, depending on experience, 15% bonus, and leading benefits.

Convenient Middlesex location. Flexible Working possible.

If you are interested in this, or any other Regulatory Affairs roles, please get in touch with Julian Turner at Turner Regulatory Recruitment on 0203 695 9477/07447 977 330 or, or by clicking Apply Now.

Apply for this job: Regulatory Affairs Manager / Life-cycle, Europe - Flexible Working

Contact Information:

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

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