Associate Director​/Director, GRA, Regulatory Affairs Head

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life‑changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

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.

• 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.
• Facilita…