Director, Regulatory Affairs (Regulatory Strategy)
Director, Regulatory Affairs - CADAs a Director, Regulatory Affairs, you will create a culture of, process improvement with a focus on streamlining our processes, adding value to our business and meeting client needs. Representing ICON as a Subject Matter Expert for Regulatory Affairs in the Canadian market you will proactively communicate objectives and results with clients offering strategic regulatory advice.
In this role, you will be responsible for regulatory strategy for a combination of current and prospective clients in Canada for drugs, biologics and combination products. As a senior member of the Regulatory Consulting Solutions team, you will further be responsible for the strategic approach and client interactions necessary to securing new and repeat business, facilitating issue resolution and ensuring project/program timelines/budgets are met.
The Role:- Actively anticipate, develop and implement initial or alternative regulatory strategies for contracted clients.
- Act as scientific thought leader for ICON. Support initiatives to ensure ICON is at the leading edge of new regulatory developments.
- Provide clients with strategic advice in response to their queries, based on regulatory experience and area of expertise, consulting with other resources within the organization as required.
- Manage workflow including prioritizing project objectives and establishing timeframes for projects with clients and managing client contracts.
- Effectively prioritize and complete multiple projects within established timeframes and within budget, Train, coach, and develop assigned individuals to build overall team expertise.
- Oversee preparation and review of scientific and regulatory documents and communication to Regulatory Authorities, in collaboration with internal and external functional 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 as applicable.
- Function as primary liaison with Health Canada for designated projects and designated clients.
- Lead Health Canada for biologics, small molecules, and combination products. Rare disease area experience would be an asset.
- Support business development.
- Conceptualize and draft complete proposals based on a client idea or (Request for Proposal (RFP) including independent development of project plans and scientific content for clients. Achieve a good conversion rate of submitted to won proposals.
Knowledge/Skills/Attributes- 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
- Rare disease area experience is an asset
- 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
To be successful in the role, you will have:- Bachelor's degree in a relevant discipline, preferably in life sciences, or other healthcare field.
- Advanced degree (MSc., PhD., M.D., Pharm.D, MBA) in the biological, medical, chemical or engineering field may be beneficial.
- 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 and people management
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Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & BenefitsICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
- 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
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
