Regulatory Affairs Expert

vor 1 Woche

Munich, Bayern, Deutschland OmniVision GmbH Vollzeit
{"title": "Senior Manager Regulatory Affairs", "content": "Overview

OmniVision GmbH, a leading non-corporate ophthalmology company in Germany, is seeking a Senior Manager Regulatory Affairs to join its headquarters in Puchheim near Munich. This is a permanent, long-term position in a successful, owner-managed medium-sized company in the pharmaceutical industry.

Key Responsibilities
  • Planning, coordination, and timely compilation and submission of marketing authorisation dossiers for ophthalmological products with chemically defined substances (new developments, in-licensed products, export products)
  • Management of marketing authorisation procedures within the EU (national, MRP/DCP)
  • Development of regulatory strategies
  • Review of marketing authorisation dossiers for in-licensing and planned marketing authorisation transfers (regulatory due diligence)
  • Preparation of modules 1, 2, 4, and 5 with the partial involvement of external consultants
  • Preparation of eCTD sequences and their submission to the competent authorities via CESP or national submission portals
  • Answering letters of deficiency (List of Questions (LoQs))
  • Conduct of the national phases with the involvement of external consultants
  • Planning, preparing, and conducting scientific advice meetings (Scientific Advice)
  • Coordination of regulatory activities in the OmniVision subsidiaries (Austria, Italy, Spain, and Switzerland)
  • Technical support for development projects
  • Monitoring, interpretation, and implementation of new regulatory requirements
  • Maintenance and updating of the company's internal authorisation database
  • Deputy head of the Regulatory Affairs department
Requirements
  • University degree in natural sciences, preferably Pharmacy, Biology, or Chemistry
  • At least 5 years of professional and practical experience in regulatory affairs (medicinal products) within the EU
  • Sound knowledge of EU/ICH regulatory guidelines and regulations
  • Open-minded personality
  • Ability to lead a team
  • Service-orientation
  • Ability to grasp things quickly, analytical thinking combined with an independent and conscientious way of working
  • Proactive thinking and acting, assertiveness, flexibility, and strong communication skills
  • Fluent in German and English with excellent oral and written communication skills
  • Excellent knowledge of Microsoft Office suite
  • Experience in the creation of eCTD dossiers and the maintenance of Regulatory Information Management Systems (RIMS)
What We Offer
  • A permanent, long-term position in a successful, owner-managed medium-sized company in the pharmaceutical industry
  • An attractive remuneration package
  • Training opportunities
  • 30 days annual leave
  • Flexible working hours including mobile working
  • Modern IT infrastructure
  • Modern offices with employee parking
  • Subsidised company meals including free drinks
  • Financial support for a job bike
  • Payment of Germany ticket
  • Subsidized company catering including free drinks
  • Company events
  • Employee discounts (gym, shopping, travel, etc.)
", "lang_code": "en-US"}

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