Regulatory Affairs Manager

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  • Secteur d'activité Distribution, Commerce
  • Date d'expiration 20 Novembre 2017
  • Nombre de postes 01 poste ouvert
  • Niveau de poste Confirmé / Expérimenté
  • Niveau d'étude (diplome) Master 1, Licence Bac + 4

Job Responsibilities:

  • Lead regulatory affairs function in providing guidance and advice to team members and related parties.
  • Guide R&D and business teams to ensure compliance of regulatory requirements and company policies for innovation projects.
  • Ensure smooth and timely introduction of new products according to sales and marketing needs.
  • Provide alternatives to the business team when there are conflicts of claims with FDA regulation.
  • Influence FDA and other government officials in decision making.
  • Take initiative in local Government Affairs activities by cultivating close relationships with government agencies as needed, in order to influence and respond proactively to the development of laws and regulations governing product registration and reimbursement issues.
  • Actively interact with external parties, e.g., industrial associations, to advance company's business agenda.

Preferred qualifications:

  • Bachelor’s Degree in a Life science, Chemistry, Biochemistry, Legal or related fields
  • Minimum 7 years working experience in Regulatory Affairs and/or other related areas
  • Experience in handling several product categories is preferred
  • Strategic thinking, Talent development, Quality orientation, Performance management
  • Good command in spoken and written English

Regulatory Affairs Manager

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