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Regulatory Affairs Manager - Labelling (m/w/d)

  • Location: Schwandorf in Bayern
  • Salary: €65000 - €70000 per annum + package negotiable per year
  • Job Type:Permanent

Posted 14 days ago

  • Sector: Pharmaceutical
  • Contact: Marlene Inderhees
  • Contact Email: m.inderhees@sciproglobal.de
  • Expiry Date: 15 February 2023
  • Job Ref: 06_2023_1673885813

Regulatory Affairs Manager - Labelling (m/w/d) | Bayern | Pharma

Are you looking for a dynamic company with daily new challenges and opportunities?

What will your tasks as Regulatory Affairs Manager - Labelling be?

  • Coordination and timely response to notices of defects
  • Creation (e-CTD) and submission of electronic marketing authorisation packages for drugs to the BfArM
  • Cooperation with the Launch Management, Portfolio Management, Quality Assurance and Pharmacovigilance departments
  • Finalisation of German technical information and package insert on the basis of English EU procedure texts (MRP/DCP)
  • Timely coordination of artwork for packaging materials and patient and professional information

Your requirements?

  • Degree in science (e.g. pharmacy, biology, food chemistry or similar).
  • Experience with BfArM Submission Operations (e-CTD, CESP; new submissions,
  • authorisation masks, variations, notifications of changes)
  • Knowledge in the maintenance of XEVMPD (EMA regulatory database).

Essential knowledge & skills:

  • Excellent written and communication skills in English and German
  • Independent, precise, well-structured and fast way of working

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!