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Job Details

REGULATORY CONTRACT / Switzerland based, Emerging Markets / Middle East and EU focus

Company: Turner Regulatory
Location: Switzerland
Reference: 10103-1
Closing Date: 28 Feb 18
Type: Contract
Salary (£): Negotiable
Benefits: NA

Job Summary:

Regulatory Contract - 4 to 6+ months; based in Switzerland; Emerging Markets/Middle East/GCC and EU focus; Regulatory Strategy and Coordination

Requirements:

REGULATORY CONTRACT – 4 TO 6 MONTHS+ IN DURATION!! BASED IN SWITZERLAND.

A seasoned Regulatory Affairs Professional is sought, experienced in Emerging Markets and Europe – this is Strategy and Coordination role. Rare Diseases Portfolio. Top Biopharma in Switzerland!! Good Middle Eastern and GCC experience is a distinct advantage. CMC/non-CMC combination.

Are you a Regulatory Project Manager/Manager, adept in International/Emerging Markets/Middle East and European Regulatory Strategy and Coordination? If so, this is the opportunity you have been waiting for. This Regulatory Contract role is for a fast-growing and highly successful Biopharma in Switzerland with a significant portfolio of rare disease products; the position will be based in Switzerland. The role is focused on a variety of Regulatory activity, including Strategy across Late Phase, New Product Registrations and Post marketing (largely).

Reporting to The Head of Regulatory, Emerging Markets, you will Project Manage & Advise on European and International Regulatory Affairs Strategy and Coordination!! Technically, you will have good working knowledge and experience of: CMC and non CMC activity; Clinical/Development Regulatory Affairs, Registrations and Post approval (mostly): CTA's and other Development Regulatory activity, CTD/Dossiers for MAA's; National Submissions/MRP, DCP and Centralised Procedure; Post marketing: Type Ia, Ib and II Variations and Renewals; Labelling, PIL's and SmPC's. Scientific Advice meetings and PIP's. Orphan Drugs.

You will collaborate closely with all other key Global Regulatory Affairs stakeholders, including other Global Regulatory Leads, Labelling, CMC, Regulatory Operations, European Regulatory Teams and Regulatory Affiliates, in order to ensure that all aspects of the Regional Strategy is observed and implemented.

You will be adept in Regulatory Strategy & Tactics and have particularly good experience in dealing with Affiliates throughout the EU and Internationally/Emerging Markets/Middle East. Ideally, you will have experience in Registrations and Post marketing/Life-cycle maintenance with some late Phase exposure. You may be required to interface with Commercial Teams and will operate as the primary interface with European and International Affiliates across numerous Therapeutic Areas. You will possess good commercial awareness and an excellent eye for detail.

Candidates from a Pharma, Biopharma, or perhaps a CRO background, in Emerging Markets/Middle East and European Regulatory Affairs Strategy and Project Leadership, and with approximately 5-12 year's experience, should be suitable for this position.

Good hourly rates (may be negotiable). Great Switzerland location.

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 by julian@turnerregulatory.com, or submit an application by clicking Apply Now.

Apply for this job: REGULATORY CONTRACT / Switzerland based, Emerging Markets / Middle East and EU focus

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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