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Labelling Regulatory Affairs Manager

Employer
Planet Pharma Staffing Limited
Location
Cambridge, Cambridgeshire (GB)
Salary
Competitive hourly rate
Start date
24 Sep 2019
Closing date
24 Oct 2019

View more

Discipline
Regulatory Affairs, Labelling
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

Job Details

 

Job Summary

Are you passionate about making a difference to patients’ lives? Do you want to build a strong career within a company that excels in delivering high quality research? Why not let our client realise your potential? Join one of the most successful, internationally recognised and established clinical teams in the industry.

 

Company Statement

Our client is one of the largest, most reputable clinical research orginisation who research, develop, manufacture and market their own products. They are a pioneer in leading edge research in drug trials and medical devices, they bring novel therapies to improve quality of patients’ lives around the world!

 

Responsibilities

  • Provide regulatory expertise for the assigned marketed products.
  • Labelling aspects to support timely product launches.
  •  Achieves this by understanding the EU regional business goals 
  • Lead cross functional labelling project teams 
  • Execute error free product labels in 49 countries in Europe. 
  • Create Patient Information Leaflets (PIL) in central Europe to ensure Patients can safely use products.
  • Accountable for preparing responses to labelling questions from health authorities for EU-central markets.
  • Develop EU package component labels
     

Qualifications

  • 6-8 years experience in regulatory affairs 
  • Experience with Marketed Products
  • Preference for experience from Pharma
  • Life Sciences Degree
  • Excellent communication skills in English 
  •  Oral and Written Communication and Presentation Skills 
  • Project Management skills such that candidate can work independently  

  • Relationship Management 
  • Influencing, Negotiation and Decision Making Skills 

  • Extends capabilities by working closely with senior staff/experts within and outside the internal organization

 

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age

Company

Planet Pharma was founded by a dedicated team of professionals with extensive experience supporting the pharmaceutical, biotechnology, and device industries.

Our goal is to create an organization that strengthens the employer-employee dynamic by connecting clients with talent. This results in making staffing more personal and creating enduring, valuable relationships. We value communication with our clients and make it our priority to have the hiring process be as fast and successful as possible.

We leverage cutting-edge technology and flexible service delivery models that provide efficient, personalized solutions for your business.

Our global headquarters is in Northbrook, IL and branch offices are based across the United States and Europe.

Company info
Website
Telephone
+44 203 868 1000
Location
10 Greycoat Place
London
England
SW1P 1SB
United Kingdom

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