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Regulatory Affairs Associate

Employer
i-Pharm Consulting
Location
Berlin, Germany
Salary
Negotiable
Start date
24 Feb 2020
Closing date
9 Mar 2020

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Contract
Experience Level
Entry level

Job Details

Position: Regulatory Affairs Associate

Employment type: 12 Month Contract - Likely Extension

Location: Berlin

About Our Client

Our client is a global contract research organization supporting data management, biostatistics, statistical programming, clinical operations, regulatory affairs, safety, pharmacovigilance, toxicology, medical affairs, medical writing, quality, risk, and compliance services to the pharmaceutical, biotechnology, and medical device industries worldwide. They continuously strive to raise the standard of excellence through accuracy and efficiency to achieve the highest quality output for our Customers. The company was established in the US in 1995, and has grown to more than 1,700 employees worldwide, with key offices and delivery centers in the US, UK, China, India, Armenia, Japan and throughout the Asia-Pacific region.

Job Summary

General Summary

  • As a Regulatory Affairs Executive you will be responsible for pharmaceutical products regulatory life cycle management in the local affiliate/market.
  • You will organize regulatory information and track submissions, support compilation of dossier applications, coordinate certificates and sample issues, maintain RIM information.

Duties & Responsibilities

  • Collect and coordinate information and compile documentation for submission to regulatory agencies or to commercial partners.
  • Timely compile materials for license renewals, updates and registrations
  • Maintain regulatory files/database and chronologies in good order. Maintain system for tracking changes, in documents submitted to agencies or partners.
  • Coordinate the regulatory reviews of customer complaints and define the regulatory reportability.
  • Coordinate samples and certificate.

Essential Skills Required & Education

  • Minimum of 1-2 years of professional experience in a direct regulatory function within the pharmaceutical/consumer healthcare industry/CRO
  • Bachelor's degree or higher in life sciences or related field
  • Demonstrated ability to work independently with minimal direction from managing supervisor

Computer/Software

  • Proficient in Microsoft Word, Excel, PowerPoint, Outlook.

Other Skills

  • Strong verbal & written communication skills.
  • Fluent in German and English (reading and writing)

APPLICANTS MUST BE BASED IN GERMANY ALREADY, HAVE DIRECT REGULATORY AFFAIRS EXPERIENCE AND SPEAK GERMAN. RELOCATIONS WILL NOT BE CONSIDERED.

Company

i-Pharm Consulting provides Talent Solutions for the global Life Sciences sector.

We are an award-winning international life sciences recruitment company with offices in London, Munich, Frankfurt, Sydney, New York, Charlotte, and Los Angeles. In a highly competitive marketplace, we connect top talent with the very best opportunities.

Since 2008, i-Pharm’s independent, expert, and ethical approach to procuring talent has helped power the pioneering progress made by Pharmaceutical, Biotech and MedTech companies around the world. 

With offices across 3 continents, we have teams servicing the major global life science hubs. We combine local knowledge, with a global network of contacts that allows us to bring together talent and opportunity when it matters most.

For candidates, we become “career partners”. We know them as people, not CVs, learning about their aims, motivations and personal situation. We build open dialogue, provide honest advice and offer ongoing support, whether or not we’re currently working with them. ​

As a result, we have supported many specialists in this focused field throughout their careers, helping them plan their path through life sciences by identifying the right roles for them, not just any roles to suit us.

We change the lives and trajectory of our candidates' careers by offering incredible opportunities with the best clients in the sector.

 

Company info
Website
Telephone
+44 (0) 20 3189 2299
Location
52 Bedford Row
London
England
WC1R 4LR
United Kingdom

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