Director, Head Of Regulatory Affairs Canada

 Canada, Mississauga, Ontario
 3 weeks, 2 days ago

A career with EMD Serono is an ongoing journey of discovery: our 56,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.

The Director of Regulatory Affairs, Canada will report locally to the Managing Director and globally to the Global Head of Regulatory Affairs and will be responsible for all regulatory activity within the Canadian organization. This includes the overall direction and management of Regulatory Affairs in Canada. In addition, this role will be the primary liaison between Global Head Offices, the US Corporate Head Office, as well as with the Canadian Health Products and Foods Branch (HPFB) for these key areas.

Your role:  

You will ensure high quality submissions and efficient and impactful negotiations with the HPFB that result in favorable terms for the HC approval and subsequent life-cycle management. You will also ensure all practices and product-related activities undertaken by EMD Inc., Canada both prior to and following approval, comply with the regulations set by the federal, provincial governments and industry guidelines of Canada, ensuring promotional materials and products on the market comply with approved dossier and product monograph.

You will collaborate with the Medical Department, Business Units’ Marketing and Sales teams, Patient Safety, Quality Operations and Supply Chain to enhance life cycle management and continued market availability of products and devices across all therapeutic areas. You will also be a member of the Canadian Leadership Team, Canadian and Global New Product Development Teams, and additional ad hoc Canadian and Global teams as required.

Who you are:  

Minimum Qualifications:

  • MSc in Biological sciences or equivalent
  • Minimum of 15 years’ experience in the proprietary pharmaceutical industry/government in the areas of research and development, operational management/project management, product safety and pharmacovigilance, regulatory affairs and quality operations.
  • Minimum of 8 years in people management or team leadership role and have demonstrated team leadership skills.
  • You have a comprehensive understanding of the Canadian Food and Drug Regulations and some exposure to European and US drug law and demonstrated strategic thinking and ability to create department strategy.
  • You also have excellent project management, written communication, presentation and teaching skills, as well as a willingness to travel.
  • You also are able to build strong relationships with Key Opinion Leaders and have the ability to understand and effectively communicate scientific information.
  •  Preferred Qualifications:

  • PhD/PharmD strongly preferred, and an MBS as an asset.
  • Multilingual (English and French) is also preferred
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