Head, Regulatory Affairs, General Medicine and Vaccines Canada
Responsibilities
Provide leadership to a team of regulatory professionals for regulatory affairs activities including early approvals and regulatory compliance activities throughout the entire product lifecycle. Ensure team maintains compliance to provision of current and accurate data in internal database systems. Evaluate business development opportunities to assess optimal regulatory strategy. Provide strategic direction and leadership in the management of clinical trial regulatory activities. Participate in cross-functional leadership teams. Review and provide comments on Health Canada draft guidelines and policies. Develop good scientific skills in core therapeutic areas. Maintain awareness of new and emerging local and international regulatory trends. Ensure implementation of departmental vision and strategies into individual priorities. Provide constructive feedback and coaching to direct reports. Establish and maintain a network with key corporate regulatory sites, business units, Canadian regulatory authority, key opinion leaders, and industry advocacy groups.
Required skills
Leadership and managerial skills. Strong decision-making, communication, project management, and risk analysis skills. Building effective teams. Developed change leadership skills. Strong strategic and operational thinking. Excellent negotiation skills. Ability to manage and influence key stakeholders. Fosters innovation.
Preferred skills
French language proficiency. Veeva Vault database familiarity.
Seniority
Head / Manager level (5+ years experience).
Domain
Regulatory Affairs, General Medicine, Vaccines, Biopharma.
