Associate Director/Director, GRA, Regulatory Affairs Head – Canada
About The Position
The purpose of the GRA, Regulatory Affairs Head – Canada is to lead the Regulatory Affairs Group to ensure the success of new product registration, line extensions and new indications in alignment with the affiliate business plan, while maintaining compliance for all products with local regulations and quality system requirements. To create an environment of operational excellence through regulatory expertise by managing and developing direct reports and collaborating with cross-functional teams to successfully achieve affiliate regulatory objectives. This is a hybrid role – onsite presence at our Toronto office will be 10 days or more per month (or at least 50% of the time), determined in collaboration with your manager and based on business needs. This role is eligible for additional forms of compensation, such as participation in the Lilly Bonus Program and a car allowance. This posting is for an existing vacancy. The GRA, Regulatory Affairs Head – Canada also engages with Regional EuCan Regulatory and Canadian affiliate therapeutic medical leads to reinforce alignment of regulatory strategy between the Canadian affiliate, GRA and Global Product Development Team/Business Unit.
Requirements
- Relevant scientific degree or Bachelor's degree (or higher) in physical or biological sciences
- Significant working experience of at least 5 years in Regulatory Affairs, ideally within pharma
- Demonstrated experience with the Health Canada regulatory framework (CTA/NDS pathways, Food and Drug Regulations)
- Strong team leadership experience with proven experience in retention and development
- Problem solving skills, sound clinical/regulatory judgement; decision making capability in pressurized circumstance
- Strong interpersonal, team working, negotiating, writing, presentation and communication skills
- Experience working in and leading a diverse and multicultural team
- Influencing skills
- Proven experience maintaining relationships and reputation with vendors
Nice To Haves
- Bilingual proficiency (English/French) considered an asset
Responsibilities
- Develop and implement the regulatory plan and strategy
- Ensure local regulatory strategies are aligned to global strategy (e.g. Accelerate Reach and Scale goals, product claims and labelling)
- Ensure submission and approval of high-quality regulatory applications within planned timelines
- Actively participate in the affiliate launch teams, anticipating and delivering regulatory outcomes to support the affiliate launch plan.
- Represent the Regulatory Affairs function in Affiliate Lead Team, New Product Planning discussions
- Represent Lilly in external industry meetings
- Maintain awareness of current regulations and anticipate implications and opportunities of changes and communicate these changes to management and cross-functional experts and implement locally.
- Interact directly or facilitate interactions with regulatory bodies on a regular basis
- Lead Health Canada CTA and NDS/submission strategy for Canada, including combined-indication filings and above-country access requests (e.g., pre-NOC SAP access)
- Maintain awareness of regulatory-HTA interdependencies (e.g., CDA-AMC/pCPA timing) to inform submission sequencing and affiliate planning
- Implement robust processes to keep regulatory archive complete and up-to-date and to ensure that all current licenses and labels are readily available.
- Manage and support internal and external audits / assessments / self-inspections in collaboration with Regulatory Quality personnel.
- Lead and coordinate implementation of corrective/preventive actions
- Lead Regulatory quality oversight of Third Parties
- Raise awareness to leadership and relevant functions on compliance issues and initiatives and provide technical support to other affiliate functions.
- Ensure bilingual (English/French) regulatory documentation and labelling compliance specific to the Canadian market
- Maintain inspection readiness for evolving regulatory guidance (e.g., ICH E6(R3)) and lead affiliate response to related inspection inquiries
- Ensure adherence with global labelling procedures and document relevant exceptions
- Consistently participate in affiliate cross-functional teams and provide regulatory status updates, input and knowledge.
- Ensure alignment and implementation of launch readiness initiatives.
- Facilitate and maintain relationships with key Regulatory officials
- Provide affiliate training and education on regulatory matters and provide regulatory input to affiliate strategic initiatives to improve and maintain understanding of regulatory affairs within affiliate leadership.
- Partner with Regulatory Policy leader on external engagement for Canada.
- Dynamic leader that challenges the status quo internally and in interactions with Health Canada. Fully engaged in and living Lilly’s ARS strategy.
- Effectively lead, manage, motivate, and mentor the Regulatory Affairs team and assist direct reports in extending their technical skills. Assure key talent retention, development, reward, and recognition.
- Attend appropriate external symposia, workshops, or conferences to develop and sustain an appropriate level of professional expertise
Benefits
- Participation in the Lilly Bonus Program
- Car allowance
- Pension plan
- Vacation benefits
- Healthcare benefits
- Flexible benefits
- Life insurance
- Death benefits
- Certain time off and leave of absence benefits
- Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
