Senior Regulatory Manager / Europe / Development and MAA's / Product Launches

Employer
Turner Regulatory
Location
Essex (GB)
Salary
£60,000-£75,000 and package
Closing date
9 Oct 2020

View more

Discipline
Regulatory Affairs, CMC, Project Management
Hours
Full Time
Contract Type
Permanent
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Senior Regulatory Manager – EU – Branded Products

Are you already a Regulatory Manager/or experienced Regulatory Project Manager, ready to take the step-up to Senior Manager? If so, this is the opportunity you have been waiting for. This Senior Regulatory Manager, EU is for a fast-growing Pharma Company in the North of London area; this organisation has a highly successful established product portfolio and is expanding into new Therapeutic areas. The company is focused on both Branded and Generic Products.

You will be required to Project Lead and Manage. You will be responsible for the Pre- and Post-Registration and Post Marketing Team and the implementation of EU and Global Regulatory Strategy to maintain the organisation’s existing product licences, and to integrate newly approved products into the portfolio.

Management of overseas Affiliates and other Partners. Liaison with appropriate Regulatory Authorities.

Technically, you will have good working knowledge and experience of Registrations and Post marketing activity and some Pre-Registration & Development experience would be beneficial: CMC and non-CMC combination; CTD/Dossiers for MAA's (ideally, all Modules 1 to 5, particularly 1/2/3); National Submissions/MRP, DCP and Centralised Procedure; Post marketing/Life-cycle management: Type Ia, Ib and II Variations and Renewals; Labelling, PIL's and SmPC's. Your geographic scope will be Pan-European and possibly some International territories.

Candidates from a Pharma or Biologics background in European Pre- and Post-Registrations and Regulatory Life-cycle management with over 7 years’ experience, and good Project Management should be suitable for this position. You will possess good commercial awareness, a solid understanding of how the business works, and possess an excellent eye for detail.

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, julian@turnerregulatory.com or by clicking Apply Now.

Turner Regulatory Recruitment is a newly established Headhunter/Recruiter created due to demand from both clients and candidates for a fast, professional and ethical Regulatory Recruitment Service that delivers. Although a newly established company, our experience is significant, spanning 12 years. We focus purely on Regulatory Affairs positions across Pharmaceuticals, Biotechnology, CROs, Generics, OTC and Medical Devices, so if you are looking for specialist expertise in Regulatory recruitment, this is the company to contact. As we specialise only in Regulatory Affairs we have to be unsurpassed at what we do; the company aims to set new standards of Regulatory Affairs recruitment services and delivery, which we hope others will follow, thereby raising overall standards.

Our staff, headed by Julian Turner, has an unparalleled track-record of success in Regulatory placements over the past 12 years, and has transacted business for Pharmaceutical Companies, Biotech’s, CRO’s, Generics Companies, Consultancies, CRO’s, Contract Manufacturers, OTC/Consumer Care Companies and Medical Devices Companies.

Contact Us
  • 71-75 Shelton Street
  • Covent Garden
  • WC2H 9JQ
  • United Kingdom
  • 0203 695 9477
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