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Manager Regulatory Affairs (m/f/x) | Mannheim area / remote

  • Salary: negotiable per year
  • Job Type:Contract

Posted 17 days ago

  • Sector: Pharmaceutical
  • Contact: Sebastian Gotzler
  • Contact Email: s.gotzler@sciproglobal.de
  • Start Date: asap
  • Expiry Date: 13 August 2021
  • Job Ref: RA_2021_21_1626255415

Manager Regulatory Affairs (m/f/d) | Mannheim area / remote | Pharma

In this position, you will work on the approval procedures for preparations at national and international level. You will be in regular contact with Health Authorities and provide regulatory strategy to product lifecycle planning!

What are your tasks as Manager Regulatory Affairs?

  • Global regulatory life-cycle management for licensed products (e.g. EU national procedures and MRP/DCP)

  • Provide regulatory strategy to product lifecycle planning

  • Timely management and preparation of high-quality regulatory documents and submissions (eCTD)

  • Act as the company's primary point of contact for Health Authorities and establish effective working relationships with regulatory consulting agents

  • Review of educational and promotional material to ensure compliance with applicable regulations

  • Coordinate Health Authority response teams

  • Represent regulatory as member of Project Teams and assure Regulatory Affairs input into designated projects

What does the position offer to you?

  • Contract: unlimited & full time

  • Salary: base salary + bonus

  • Holidays: 30 days / year

  • Working hours: 40 hours / week

  • Accessibility: on-site parking and very good public transport connections

  • Start date: At the next possible time

  • Position can be filled either on site or remote with ad-hoc traveling and / or regular presence on site (negotiable)

What requirements do you need to bring?

  • Ph.D. or master's degree in Pharmacy, Chemistry, Biochemistry, Biology, Biotechnology or comparable

  • At least 3 years' experience in the field of Regulatory Affairs in a global environment

  • Good experience in Life-Cycle Management (post-authorization with European Health Authorities) as well as EU national and MRP / DCP procedures

  • Excellent written and verbal communication skills in English; German at least a good B1 would be needed

  • Excellent communication skills as well as ability to work as a member of a team independently

  • Very good comprehension, independent way of working, intercultural competence

Contact for application: