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2017-38718

2017-38718

Title 
Senior Manager, Regulatory Affairs CMC
Job Locations 
-
United Kingdom
Germany
Posted Date 
2/1/2017

More information about this job

Overview

Due to our new partnership agreement with a global pharmaceutical company, PRA Health Sciences are excited to offer new openings for CMC Manager, Global Regulatory Affairs to join our embedded team at the client offices.

 

 

This innovative partnership provides an operating model that combines operational expertise with PRA's wide range of global capabilities. This flexible approach will facilitate the development of new medicines by focusing resources, teams and activities where needed, an important requirement for an industry-leading, highly agile R&D organisation focused on meeting patient needs.

Responsibilities

The role sits within a global team working on the business' portfolio of Marketed Products. This is an permanent opening with options for both home or office based working. 

 

Role overview:

  • Developing and leading the execution of Regulatory CMC development and registration strategies.
  • Apply a comprehensive understanding of global Regulatory Affairs CMC regulations and guidelines to projects to enhance probability of regulatory success and regulatory compliance.
  • Manges the interactions with international Health Authorities and successfully negotiate Regulatory Affairs CMC matters, directly and indirectly.
  • Developing constructive relations with key internal and external colleagues, including Alliance Partners will be a focus in this role.

Qualifications

To be considered for this opportunity, you will have;

  • A life sciences degree (BSc / MSc / Dip pharm)
  • Regulatory CMC experience combined with relevant pharmaceutical experience (e.g. Pharmaceutical Development, Analytical Development, Production, Quality Assurance).
  • You will have proven ability to liaise with Regulatory Agencies having served as the lead in agency interactions and product development meetings.
  • An understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support is essential. 
  • You will have demonstrated leadership and problem solving skills, along with the ability to work independently as well as in team-oriented environment.
  • Fluency in written and oral English is essential.

 

Together with a competitive salary, we offer a comprehensive range of benefits and an excellent working environment. As we continue to expand, there will be career opportunities on a truly global scale.

 

PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.

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