Director of Regulatory Affairs
EnergyHubSalary not specified
Sr. Director - Quality, Safety, & Regulatory Affairs at Eli Lilly and Company
Toronto, Ontario, Canada
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, HealthcareIndustries
Requirements
- Strategic leadership experience in quality assurance/control, regulatory affairs, and safety/pharmacovigilance within pharmaceuticals, preferably in a Canadian affiliate context
- Deep knowledge of Health Canada regulations, GxP (GMP, GCP), Health Products and Food Branch (HPFB) requirements, and global standards
- Expertise in Quality Management Systems (QMS), risk-based controls, data integrity, deviation management, CAPA, and audit/inspection readiness
- Experience leading investigations of critical quality events, recalls, deviations, and product complaints
- Regulatory strategy experience for product submissions, lifecycle management, labeling, promotional materials, and clinical trial applications (CTAs)
- Pharmacovigilance knowledge for adverse event reporting, safety signals, and patient safety governance
- Qualifications to serve as Senior Person in Charge (SPIC) for controlled and special security substances, with knowledge of security controls and product diversion strategies
- Proven ability to lead and develop high-performing multidisciplinary teams with strong technical expertise and decision-making accountability
- Experience in quality oversight of third parties, vendors, and service providers, including quality agreements
- Ability to represent affiliate in global/regional forums, influence policy, and drive quality culture and operational excellence
- Willingness to work hybrid role with onsite presence at Toronto office 10 days or more per month (at least 50% of time)
Responsibilities
- Serve as Site Quality Leader / Product Quality Representative, ensuring GxP quality processes across importation, distribution, commercialization, and sampling meet Health Canada and global standards
- Oversee and continuously improve the affiliate’s Quality Management System (QMS), including risk-based controls, data integrity, deviation management, CAPA effectiveness, and audit readiness
- Lead quality oversight of third parties, vendors, and service providers, ensuring quality agreements and performance monitoring
- Drive quality culture, embedding GMP compliance, ownership, and proactive risk management across the affiliate
- Lead investigations of critical quality events, including recalls, deviations, and product complaints, ensuring timely reporting and root cause resolution
- Provide strategic direction on regulatory strategy for new product submissions, lifecycle management, labeling, and promotional materials
- Ensure all regulatory filings and HPFB registrations are maintained for marketed and investigational products
- Act as primary affiliate liaison with Health Canada for regulatory interactions and inspections
- Partner with clinical development teams to support CTAs and GCP compliance
- Ensure timely and accurate reporting of adverse events, product complaints, and safety signals per Canadian and global requirements
- Provide governance and oversight of pharmacovigilance activities to maintain patient safety
- Maintain inspection readiness and represent affiliate for safety-related audits and inquiries
- Serve as SPIC for controlled and special security substances, ensuring compliance with Health Canada and Lilly’s Global Product Diversion Control Strategy
- Oversee security controls, risk assessments, and procedural compliance for controlled substances
- Lead and develop a high-performing multidisciplinary team (Quality, Regulatory, Safety), fostering technical expertise, accountability, and career growth
- Represent the affiliate in global/regional forums to influence policy and share best practices
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
Is this a remote role or does it require office presence?
This is a hybrid role requiring onsite presence at the Toronto office for 10 days or more per month (or at least 50% of the time), determined in collaboration with your manager and based on business needs.
What are the key responsibilities in quality leadership for this role?
The role involves serving as Site Quality Leader, overseeing the Quality Management System, leading quality oversight of third parties, driving quality culture, and leading investigations of critical quality events.
What regulatory affairs duties does this position include?
Responsibilities include providing strategic direction on regulatory strategy for product submissions and lifecycle management, ensuring regulatory filings are maintained, acting as liaison with Health Canada, and partnering with clinical teams for trial applications.
What is the company culture like at Eli Lilly?
Eli Lilly unites caring with discovery to make life better for people, puts people first, and seeks determined individuals who give their best effort to discover life-changing medicines and give back to communities.
What makes a strong candidate for this Senior Director role?
A strong candidate will have visionary leadership skills to shape quality and safety strategies, expertise in GxP, QMS, regulatory compliance with Health Canada, and experience driving operational excellence and cross-functional partnerships.
Eli Lilly and Company
Develops and delivers prescription medicines globally
About Eli Lilly and Company
Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.
Indianapolis, IndianaHeadquarters
1876Year Founded
$1,180.1MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees
