QA Regulatory Affairs Supervisor

St.-Prex, Switzerland

Posted: 28-Aug-2018

Ref#: FER-0084


Headquartered in Saint-Prex, Switzerland, Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of reproductive health, urology, gastroenterology, endocrinology and orthopaedics. Ferring has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries. To learn more about Ferring or its products please visit www.ferring.com.

In our Headquarter in St-Prex/Lausanne (Switzerland), we are looking for an:

                          QA Regulatory Affairs Supervisor

Your mission:
You will be the key role of Ferring Swiss Manufacturing Plant (FSMP) by managing the pharmaceutical Regulatory Affairs activities linked to FSMP activities. You will be the interface between company and local development (development & pilot) and operations, (qualification / validation, QC, QA) and Global Regulatory Affairs and Affiliates Regulatory Affairs in order to support plant new products introduction in the market, plant or global changes, and ongoing follow-ups

Main responsibilities:
  • Responsible for preparing and updating Common Technical Documents (CTD) Module 2/Module 3 quality documents and review CTD prepared by Pharm. Development, qualification / validation, Operations, QC, etc.
  • Manage a team of 2/3 persons
  • Answer technical questions raised by Global Regulatory Affairs, affiliates and regulatory agencies during product registration procedures (new applications, variations, renewals, annual reports, commitments, tenders)
  • Maintain currency and consistency of regulatory documentation managed by plant QA in several regulatory data bases.
  • Approve plant drug product specifications in LIMS, in compliance with applicable registered specifications
  • Support QA teams to manage and review change requests and assess their regulatory impact
  • Manage change control activities for the plant

Required Education/ Qualifications/Skills:

  • Scientific degree (pharmacy, chemistry, biology or equivalent)
  • Experience in the pharmaceutical industry and GMP environment (5-7 years’ experience)
  • Experience in scientific writing (in English) : CTD Module 2/Module 3 documents (Worldwide environment: EU, US, China, Japan, LatAm, META)
  • Analytical skills, ability to handle several tasks simultaneously and with high accuracy, Ability to synthesize.
  • Capability to work under pressure in a complex matrix organization and demanding business networking
  • Fluent in English

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