Head of Regulatory Affairs

  • Axepta SA
  • Geneva, Geneve, Switzerland
  • 15/06/2020
Full time Data Science Data Analytics Big Data Statistics

Job Description

My client is an innovating, dynamic and growing international pharmaceutical and healthcare company currently expanding their Global Regulatory Affairs team in Switzerland, Vaud Canton.

Due to this growth my client is looking for a Global Head of Regulatory Affairs.

The position is based in Lausanne area.

Responsibilities:

  • Management of small regulatory affairs team and set priorities according business needs and managerial considerations.
  • Act as Global regulatory representative of OTC Franchise Committee
  • Ensure best regulatory strategy in compliance with requirements for new projects
  • Represent the company in meetings with Health Authorities
  • Coordinate the writing and update of dossiers according to the current Regulations
  • Ensure regulatory intelligence, monitor internal and professional communications concerning relevant regulations (ICH, GMP …)
  • Anticipate steps required to maintain regulatory compliance and initiate modifications when needed
  • Manage OTC switches including, strategy, dossier preparation, meeting with authorities
  • Establishes / validates / maintains plan for registrations, variations and renewals globally
  • Manages / monitors product information in Regulatory Information Management System, ensures information is complete and current
  • Coordinates safety variations with PV and quality variations with RA CMC
  • Manages service providers in support of the function
  • Principal Regulatory Affairs contact for assigned products
  • Select and manage service providers

Your profile:

  • Scientific degree
  • 10-15 years’ experience in Global Regulatory Affairs in the consumer care environment (OTC drugs or cosmetics)
  • Strong knowledge of the pharmaceutical industry, including solid knowledge of all associated global RA regulations
  • Experience with outsourcing Regulatory Dossier management
  • Experienced with international project management
  • Leadership, mature interpersonal, communication and organizational skills
  • Proven managerial skills

Please send your application to noliva@axepta.com