Associate Director/Director, GRA, Regulatory Affairs Head – Canada

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. 

Purpose:

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.

Regulatory Strategy

• 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

Regulatory Compliance

• 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

Labelling

• Ensure adherence with global labelling procedures and document relevant exceptions

Process Improvement and External Engagement

• 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.

Personal and Professional Development

• 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

Minimum Qualification 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

• Bilingual proficiency (English/French) considered an asset

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

Full-time equivalent employees may also be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a pension plan; vacation benefits; eligibility for healthcare benefits; flexible benefits (if applicable) life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.