Head of Medical and Regulatory Affairs - Rare Opportunity!

€90000 - €120000 per annum + Benefits + Relocation
Feb 27, 2012
Mar 27, 2012
Nikolay Dimitrov
Jobseeker Type
Organization Type
Contract Type
Full Time
Head of Regulatory and Medical Affairs - Austria - Very rare opportunity!!!

My client, the Oncology Injectables arm of a global pharmaceutical player is currently looking for a Head of Regulatory and Medical Affairs in Austria. To find out more about the company and position call Nikolay on +44 (0)207 255 6665 or e-mail Nikolay.dimitrov@secpharma.com.

As a Head of Medical and Regulatory Affairs you will provide medical and toxicological expertise in the development and maintenance of pharmaceuticals.

-Manage clinical and non-clinical studies for development and maintenance of pharmaceuticals
-Writing of toxicological statements (literature justifications on impurities, excipients and residual solvents)
-Preparation/updates of non-clinical and clinical overviews and expert statements, SmPC, Patient Information Leaflets
-Support in EU registration procedures (MRP, DCP) variations and renewals
-Answering of clinical part of deficiency letters, including contacts with assessors at health authorities
-Labelling: elaboration of PILs according to valid internal policies and EU Guidelines, and coordination of EU PIL readability tests (user tests) or bridging reports
-Regulatory intelligence: tracking of relevant clinical and non- clinical international Guidelines
-Medical support for portfolio management, development and patent departments

Minimum requirements
-PhD in chemistry or medical doctor Master of Drug Regulatory Affairs Toxicologist
-Fluent English (oral and written)
-At least 5 years in pharmaceutical industry, preferably in medical and/or regulatory affairs
-In depth knowledge of Clinical and Non-Clinical development, Regulatory Affairs, Clinical Pharmacology, Toxicology

Keywords: Regulatory Affairs, Medical Affairs, Clinical development, Non-Clinical development, Clinical Pharmacology, Toxicology

Nikolay Dimitrov
Pharmaceutical Division

+44 (0)20 7255 6665
+33 (0)170807489
+49 (0)69 222 22 888
+41 (0)44 580 3717

Email: Nikolay.Dimitrov@secpharma.com
Web: www.secrecruitment.com