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(Senior) Manager Regulatory Affairs (m/f/d) | Munich | Pharma

(Senior) Manager Regulatory Affairs (m/f/d) | Munich | Pharma

Job Title: (Senior) Manager Regulatory Affairs (m/f/d) | Munich | Pharma
Contract Type: Permanent
Location: Planegg, Bayern
Industry:
Salary: €80000 - €90000 per annum + negotiable
Start Date: ASAP
Reference: RA_2020_23_1594730407
Contact Name: Sebastian Gotzler
Contact Email: s.gotzler@sciproglobal.de
Job Published: July 14, 2020 13:40

Job Description

(Senior) Manager Regulatory Affairs (m/f/d) | Munich | Pharma

Are you interested in a highly visible position within a very innovative and growing company?

Are you looking for a friendly and highly motivated team to support you in your career growth?

Does a position in a global environment with broad range of tasks not only in the EU but also the US and Canada gain your interest?

Are you interested in globally improving health in the world?

If you want to experience this at a company focusing on the development, manufacturing, and commercialization of live-saving vaccines, then you have come to the right place!

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 for vaccines
  • Timely management and preparation of high-quality regulatory documents and submissions
  • 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 + additional 13th salary
  • 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

What requirements do you need to bring?

  • D. or master's degree in Pharmacy, Chemistry, Biochemistry, Biology, Biotechnology or comparable
  • At least 5 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 would be a plus
  • 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

What can you expect from the role?

  • An exciting position in Regulatory Affairs within a global environment
  • Great chance operating in a highly visible and key role withing the department
  • Highly motivated team of 7 people

About the client?

Our client is a fully integrated biotechnology company focused on the development, manufacturing and commercialization of live-saving vaccines. The company has a diverse and growing portfolio of vaccines, supported by proprietary development, public-private partnerships, and industry collaborations. The company was founded in 1994 with operations in Germany, Switzerland and USA. The company employs more than 500 people globally.

Are you interested in such company? Then you should apply now! If you would like to receive further or alternative positions, I would also be happy to receive your application!