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Head of Regulatory Affairs (m/w/d)

  • Location: Frankfurt (Oder)
  • Salary: €85000 - €120000 per annum + package negotiable per year
  • Job Type:Permanent

Posted 21 Tage her

  • Sector: Pharmabranche
  • Contact: Marlene Inderhees
  • Contact Email: m.inderhees@sciproglobal.de
  • Expiry Date: 08 February 2023
  • Job Ref: 03_2023_1673275766

Head of Regulatory Affairs Manager (m/f/x) | Rhein-Main Area | Pharma

Every day we take on the challenge of making a positive contribution. As Head of Regulatory Affairs Germany, you will be responsible for securing a strong commitment to compliance with the German Medicines Act to maintain national marketing authorisations, support the continuous supply of marketed products and the launch of the product portfolio of in a targeted and timely manner.

What will your tasks as Head of Regulatory Affairs Manager be?

  • Lead the regulatory team to ensure agreed objectives are achieved and responsibilities are delivered; develop talent and promote a culture of learning and collaboration
  • Manage projects related to regulatory affairs in collaboration with regional regulatory functions or country-specific commercial functions in a timely and cost-effective manner
  • Perform regulatory launch management with a focus on generic molecules in close collaboration with Supply, Quality, Marketing and Medical to ensure timely and successful commercialisation of the product
  • Oversee and enforce print submission approval as an information officer (74a AMG) for products marketed by all German companies
  • Drive the Regulatory team to meet global and regional standards and agreed deadlines (e.g. timely submission of safety data, high quality translations, RTF submissions, pharmaceutical documentation compliance)

Your requirements?

  • Doctor or master's degree in Natural science or pharmaceutical
  • At least 10 years of experience in Leadership of larges team in an international pharmaceutical Company
  • Proven experience in regulatory affairs management in the pharmaceutical industry of German Pharmaceutical law
  • depth experience of launch of generics, name changes, re branding or similar as a Project Management

Essential knowledge & skills:

  • Excellent written and communication skills in English and German

My contact details:

  • Email: inderhees@sciproglobal.de
  • Tel: 0049 (0) 89/26 20 09 25 (direct dial)
  • Xing: https://www.xing.com/profile/Marlene_Inderhees/cv
  • LinkedIn: https://www.linkedin.com/in/marlene-inderhees-376a7a16b/

I look forward to your application!