Regulatory Affairs Project Manager

Become a proactive, goal orientated and pragmatic Regulatory project manager within a leading pharmaceutical company.

Rate Negotiable Industry Life Sciences Location Germany Type Permanent Ref JO-1612-899741 Posted 184 days ago

Job Description

Regulatory Affairs Project Manager- Permanent Contract Germany 

Level: Regulatory Affairs Project Manager 
Contract: Permanent Contract  
Salary: Negotiable  
Location: Germany  
 
Summary
A proactive, goal orientated and pragmatic Regulatory project manager required to join a leading pharmaceutical company. Please see the details below:
 
Responsibilities

  • Responsible for planning, managing, tracking and on-time production of regulatory deliverables for global submissions.
  • Manages the publishing, production and archiving of dossiers across the product lifecycle
  • Act as project manager for regulatory sub teams and responsible for creating submission content plan with input from global tams
  • Responsible for high-quality dossier content production in accordance with Submission Content Plan, with on-time publishing of submission dossiers in line with target dates
  • Oversee dispatch of dossiers in conjunction with other GRA functions.
  • Responsible for accurate plans in the Regulatory Information Management System for assigned projects.
 
Education and Experience
  • Degree in relevant qualification-, PharmD, PhD, MSc etc..
  • Minimum 3 years’ experience in Regulatory affairs and good knowledge of the pharmaceutical industry with experience in Regulatory operations
  • Extensive knowledge of regional and global authority requirements
  • Strong understanding of the regulatory operations area, including processes and technology solutions.
  • Demonstrated experience in dossier production and submission in US and/or EU.
  • Strong interpersonal and leadership skills, especially within matrix organization.
  • Organized and can work independently, self-motivated and proactive.
  • Goal-oriented and pragmatic approach to work.
  • Able to develop healthy relationships with internal with internal and externa vendors
 This is a permanent contract, please make an application or contact: #LI-AT1 #LI-15

Amie Touray Consultant

"Consultant in Life Science, part of the Regulatory affairs team. Specifically dealing with CMC professionals across Europe."

+44 (0)20 7002 0000 Get in touch

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