Head of Medical and Regulatory Affairs - Rare Opportunity!

Location
Salzburg
Salary
€90000 - €120000 per annum + Benefits + Relocation
Posted
Feb 27, 2012
Closes
Mar 27, 2012
Ref
ND0043.0902.um
Contact
Nikolay Dimitrov
Jobseeker Type
Professional
Organization Type
Corporate
Contract Type
Employee
Hours
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.

Responsibilities:
-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