Senior Director/Vice President, Regulatory Affairs

 

Reporting to the Chief Medical Officer and Vice President, Clinical Development and Regulatory Affairs, the Senior Director/Vice President, Regulatory Affairs develops, proposes and executes global regulatory strategies and plans for the Company portfolio of products and product candidates from research and development through approval and post-approval responsibilities.

The Senior Director/Vice President, Regulatory Affairs interacts with external stakeholders, which may include some or all of the FDA and other health authorities globally, Key Opinion Leaders, Advisory Committees, investors, potential partners, CROs, Company’s Board of Directors and other contracted service providers and all levels of internal staff.

The Senior Director/Vice President, Regulatory Affairs leads and manages a Regulatory team located in Canada and the U.S. and chairs, co-chairs, and acts as sponsor, lead or member of a variety of committees and projects.

 The Senior Director/Vice President, Regulatory Affairs will:

  • Develop and propose regulatory strategies for the Company’s portfolio of products and product candidates in collaboration with other key functional areas and external partners as needed to establish efficient and effective paths to approval in major markets, with emphasis on the US
  • Provide strategic and operational regulatory support and advice, both personally and through Regulatory staff, to research and development teams in all areas – research, non-clinical development, clinical development and chemistry, manufacturing and controls; upon marketing approval(s), provide strategic and operational regulatory support and advice, both personally and through Regulatory staff, to Commercial and Medical Affairs teams
  • Act as Regulatory lead representing the Company at the FDA and other health authorities globally
  • Author and/or review key documents and all regulatory submissions and communications to FDA and other global health regulatory authorities in accordance with current standards
  • Oversee all aspects of the preparation and submission of all types of regulatory filings and reporting in all jurisdictions
  • Keep current with drug development and regulatory trends and requirements in the global market; analyze the impact the changes may have on the Company’s product portfolio and regulatory strategies and plans
  • Provide regulatory advice and support to Commercial, Business Development and other functional areas’ activities as required
  • Plan and manage budget proposals and approved budgets in accordance with the Company’s strategic and operating plans and Finance policies
  • Lead, direct, manage, develop, coach and evaluate direct reports and other employees in group in accordance with the Company’s Human Resource policies and plans
  • Act in accordance with general Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by employees in reporting and other departments 

Requirements:

  • BS degree (MSc preferred) and a minimum 12-15 years in a regulatory leadership role in the biotech/pharmaceutical industry
  • A strong understanding of US and EU (at a minimum) and other international pharmaceutical guidelines and regulations is required
  • Ability to strategically apply regulatory knowledge to drug development plans and supporting activities
  • Demonstrated track record playing a key role in both early and late phase development, NDA/MAA preparation, FDA experience as regulatory lead highly desired
  • Strong behavioral bias towards productivity and being proactive
  • Excellent interpersonal, communication (oral and written), analytical and organizational skills
  • Strong influencing and negotiation skills
  • Capable of managing multiple projects and complex timelines in a team environment
  • Demonstrated leadership capacity in a cross-functional project environment
  • Excellent team management skills, ability to lead, train and mentor team members at all levels; experience building teams highly desired
  • Ability to travel 15% both within North America and internationally