Regulatory Affairs Manager Europe & ROW / Emerging Markets / International - based Ireland

Cork, Ireland
60,000 - 80,000
04 Mar 2019
03 Apr 2019
Full Time
Contract Type
Experience Level

Regulatory Affairs Manager – Europe and International/ROW/Emerging Markets – based in Ireland!!

Regulatory Affairs Manager for a top Specialist Pharma focused on Innovative Products and Rare Diseases!! Project Leading and Affiliate liaison across European and International territories including LATAM, Asia, Pacific, Middle East.

Are you a Senior Regulatory Project Manager/Manager, adept in European & International/Emerging Markets Regulatory Strategy and who enjoys ‘hand’s-on activity? If so, this is the opportunity you have been waiting for.

This Regulatory role is for a fast-growing and highly successful Specialty Pharma with a significant portfolio of ‘cutting-edge’ products; this role will be based in a desirable area of Southern Ireland. The role is focused on a variety of Regulatory activity, including New Product Registrations and Post marketing.

Reporting to the Head of Regulatory Affairs and the VP, International Pharma Sales, you will advise on European & International Regulatory Affairs Strategy!! Technically, you will have good working knowledge and experience of: 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. Some working knowledge of Clinical/Development Regulatory would be desirable.

You will be adept in Regulatory Strategy & Tactics and have good experience in dealing with Affiliates Internationally. Ideally, you will have experience in taking products through Late Phase, through to successful Registrations and Post marketing.

You will 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 European and International Regulatory Affairs Strategy and Project Leadership, and with approximately 4-8 year's solid experience, should be suitable for this position. Superb organisation - a top employer with outstanding products and very desirable to have on your CV. A very competitive salary package is on offer for the right candidate.

Desirable Ireland 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 0203 695 9477/07447 977 330, or by, or submit an application by clicking Apply Now.

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