Director, Regulatory Affairs (Regulatory Strategy)

ICON plc • Burlington, PE

1d

About The Position

ICON is a global healthcare intelligence and clinical research organisation focused on accelerating the delivery of new medicines and treatments to patients. As a values-driven organisation, integrity, collaboration, agility, and inclusion are central to our operations. The Director, Regulatory Affairs – CAD role focuses on creating a culture of process improvement, streamlining operations, adding value, and meeting client needs within the Canadian market. This position involves representing ICON as a Subject Matter Expert, providing strategic regulatory advice, and managing client relationships for drugs, biologics, and combination products. The role is a senior position within the Regulatory Consulting Solutions team, responsible for strategic approaches, securing new and repeat business, resolving issues, and ensuring project timelines and budgets are met.

Requirements

• Minimum of 12-15 years related experience in Regulatory Affairs setting, in Pharma or CRO, with emphasis on Canadian Regulatory Affairs
• Experience supporting client development activities
• People management experience
• Bachelor’s degree in a relevant discipline, preferably in life sciences, or other healthcare field.
• Understanding of Canadian regulatory landscape; experience with Canadian regulatory strategy and submission requirements
• Leads Health Canada interactions and pre-submission meetings
• Experience with small molecules, biologics, gene therapy and cell therapies
• Post market support experience
• Excellent verbal and written communication: Conveys thoughts in a clear, concise, and accurate manner. Uses appropriate regulatory, medical, and scientific nomenclature. Listens carefully and asks questions when necessary to ensure understanding
• Planning and organization: Plans work effectively to meet goals and ensure timely completion of assignments. Manages time effectively
• Attention to detail: Identifies and resolves discrepancies across various source documents, including published and unpublished documents. Notes and resolves errors in written documentation
• Experience in client interaction and/or in a consulting environment is advantageous
• Experience in regulatory writing, meeting packages, accelerated pathways, dossiers preparation

Nice To Haves

• Rare disease area experience would be an asset.
• Advanced degree (MSc., PhD., M.D., Pharm.D, MBA) in the biological, medical, chemical or engineering field may be beneficial.

Responsibilities

• Actively anticipate, develop and implement initial or alternative regulatory strategies for contracted clients.
• Act as scientific thought leader for ICON and support initiatives to stay at the leading edge of new regulatory developments.
• Provide clients with strategic advice based on regulatory experience and expertise, consulting with internal resources as needed.
• Manage workflow, prioritize project objectives, and establish timeframes for projects with clients, including managing client contracts.
• Effectively prioritize and complete multiple projects within established timeframes and budget.
• Train, coach, and develop assigned individuals to build overall team expertise.
• Oversee preparation and review of scientific and regulatory documents and communications to Regulatory Authorities, in collaboration with internal and external experts.
• Oversee preparation of/ review/write or update Health Canada core regulatory submissions such as Module 2 clinical/non-clinical sections for NDS/SNDS, gap analysis, priority review requests.
• Develop and implement strategies and regulatory submissions (NDS/SNDS, CTA) and post-licensing activities.
• Function as primary liaison with Health Canada for designated projects and clients.
• Lead Health Canada interactions for biologics, small molecules, and combination products.
• Support business development efforts.
• Conceptualize and draft complete proposals based on client ideas or RFPs, including independent development of project plans and scientific content, aiming for a good conversion rate of submitted to won proposals.

Benefits

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

What This Job Offers

• Job Type: Full-time
• Career Level: Director