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Regulatory Project Manager (m/w/d) in Munich

Regulatory Project Manager (m/w/d) in Munich

Job Title: Regulatory Project Manager (m/w/d) in Munich
Contract Type: Permanent
Location: Munich, Bayern
Industry:
Salary: €60000 - €90000 per annum + negotiable
Start Date: ASAP
Reference: RA_2020_13_1583752549
Contact Name: Sebastian Gotzler
Contact Email: s.gotzler@sciproglobal.de
Job Published: March 09, 2020 11:15

Job Description

Regulatory Project Manager (m/w/d) in Munich

Is strong team spirit very important to you? Are you an enthusiastic natural scientist and have a fable for meticulous and super-precise work? Your fingers tingle when you hear the word drug approval? Can you identify yourself with the role of covering project management of regulatory activities from early development (pre-clinical scientific advice) to project management of dossier preparation for MAA/BLA/NDA filing?

If you feel like experiencing this with an international and leading consultancy offering a wide range of services in the field of regulatory affairs, then you've come to the right place!

What are your tasks & responsibilities as Regulatory Project Manager?

  • Manage EU and FDA Marketing Authorisation Application procedures including:
    • preparation of Module 1 documents
    • assignment and management of team resources
    • co-ordination of Mod 2 & 3
    • tracking Modules 4 & 5
    • preparation and track project plans
    • interaction with Regulatory Agencies on behalf of clients before, during and after approval
    • management the MAA procedure on behalf of clients
  • Provide regulatory advice to clients
  • Prepare and manage project plans
  • Request Scientific Advice meetings on behalf of clients including preparation of supportive documentation

Which requirements are needed as Regulatory Project Manager?

  • Master of PhD. in life sciences, medicine or veterinary medicine
  • At least 5 years Project Management and Regulatory Affairs experience, understanding of FDA and ICH regulations and guidelines
  • Competent with Project Management tools and software
  • Excellent communication skills, strategic thinker, solution orientated
  • Ability to work independently and manage multiple tasks simultaneously under time constraints. Flexible with excellent prioritisation skills

What can you expect as Regulatory Project Manager?

  • Professional and friendly working environment
  • Modern office space in the south of Munich
  • Working with a dedicated small and effective team
  • Very competitive salary
  • Attractive bonus system tailored to your expertise and business success

About the client?

Our client is a leading consultancy for regulatory affairs, supporting small and big biotech and pharmaceutical companies in all phases of drug and device development, from defining the right strategy to submitting the marketing authorisation application, regulatory maintenance etc. All consultants have gained many years of experience within the industry and have know-how and proficiency in the various disciplines required for drug development. The company was founded in 2002 and delivered quality service to more than 500 clients in Europe, North America, Japan, Australia and Asia.

Contact for application: