Regulatory Affairs Manager - Great Location!

London, United Kingdom

Reference	AT/ 65856/03
Contract type	Permanent

Regulatory Affairs Manager - Great Location

Salary: Upon Request

Location: Portugal

Reference: AT/ 65856/03

Regulatory Affairs Manager - Pharmaceuticals - Great Sunny Location! - Portugal!

Are you looking for a Regulatory Affairs position with a difference? If you are looking to spend your spare time in a relaxed and laid back European environment where the sun is always shining and the people are friendly and welcoming then this is a Regulatory Affairs Manager position that you should consider.

My client is an international Pharmaceutical company with headquarters in Portugal. I am looking for a Regulatory Affairs Manager with experience in NCE submissions and previous dealing with regulatory agencies to join my clients international and multicultural team. This is a fantastic opportunity for someone who is looking to experience a new company and culture and still experience career progression and professional development with a pharmaceutical company that has a strong product pipeline and a great industry reputation.

This position as Regulatory Affairs Manager will see you ensuring the registration submissions, renewals and variations of the Market Authorizations of my client's products, in accordance to the current regulations, in the different markets/countries where they operate. You will be providing regulatory support for products at various stages of development, Clinical Trial applications and query responses, end of trial notifications, and protocol amendments; ensuring the smooth conduct or closure of the trials in compliance with EMA and FDA legislation. You will be involved in ensuring compliance with regulation requirements in particular timelines for clinical study reports as per EMA and FDA legislation as well as supporting the Regulatory Director in Marketing Authorization Application (MAA) via the CP for the new chemical entities: pre-submission Agency interactions, dossier preparation, query responses. Post - authorisation activities that you will be involved in include: managing, leading and ensuring regulatory compliance products, via the Mutual Recognition Procedure (MRP) or Centralized Procedure (CP): Labelling negotiations follow up measures and variations, renewal, PSUR, Agency query responses. You will also be required to act as a single point of contact with EMA, representing my client's EU country affiliates, ensuring appropriate documents and responses are provided to Regulatory Agencies to address issues raised and defend a product.

APPLY NOW. Spend your days off lazing away on a beach and enjoy the laid back culture of Portugal whilst developing your Regulatory Affairs career. Please send a Word version of your CV to a.tait@nonstop-recruitment.com or please call Alex Tait at NonStop Recruitment on +44 (0) 2079402105 for a confidential conversation regarding this job opportunity.

Key Words: Regulatory Affairs, Reg Affairs, Regulatory Affairs Manager, Regulatory Affair Specialist, Europe, UK, Portugal, Spain, France, Italy, Germany, Switzerland, Belgium, Greece, EU, Pharma, Pharmaceuticals, Pharmaceutical, Biotechnology, Biotech, FDA, EMA, European Medicines Agency, MAA, PSUR, CTA, Clinical Trial Application, New Chemical Entities, NCE

Expires on

5/24/13 4:24 PM

comments powered by Disqus