Snr Specialist Regulatory Affairs

Highly Competitive
  1. Permanent
  2. Consultant / Specialist
  3. Germany
München (80335), Germany
Posting date: 24 Mar 2021

We are recruiting a Senior Specialist Regulatory Affairs Lead for Germany to ensure regulatory compliance of drugs commercialised in Germany with the pharmaceutical and legal regulations in accordance with the applicable regulations.

Job Responsibilities

  • Local implementation of EU-registered medicinal products
  • Labelling changes, i.e. translation checking and implementation into national texts
  • Updates of educational materials
  • Updates of packaging materials
  • Deputy for local implementation activities
  • Oversight and control of local implementation for all Alexion products in Germany
  • Compliance with additional risk minimisation measures
  • Deputy for additional risk minimisation measure activities
  • Deputy for regulatory review of promotional and non-promotional materials if necessary
  • Management of all regulatory SOPs in the quality management system (QMS) in cooperation with QA, such as updates/creation of new SOPs and training
  • Compliance with the quality management system (QMS) and necessary actions, such as Deviations and Corrective Action Preventative Actions (CAPAs)
  • Invoice and PO management
  • Material management in logistics service centre HyBizz/C4: coordination of printed regulatory texts (educational materials, SmPC)
  • Submission of product changes to IFA; submission of updated SmPCs and educational materials to ABDATA

Skills and Requirements

  • At least 3 years' experience in the pharma/biotech industry including experience in a similar position.
  • Good knowledge of regulatory framework in Germany and EU
  • Experience in interactions with authorities
  • Experience in Risk Management Plan implementation activities
  • Experience in QMS/SOP management
  • Social skills and active collaboration with cross-functional colleagues (e.g. CMC, quality assurance, drug safety, marketing)
  • Very good written and spoken German and English

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.