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Eli Lilly and Company

Regulatory Associate/Sr Regulatory Associate /Manager, GRA, Canada affiliate

ON, Canada
Ontario, Canada, Canada

$64,870 - $147,400 · Full-time

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Job details

Pay: $64,870 - $147,400
Job type: Full-time
Apply by: Nov 5, 2026
Experience: At least 1-3 year industry related experience in regulatory affairs and experience of dealing with external regulatory agencies, the health care system and marketing needs
Posting language: English
Posted: Oct 6, 2026

Original job description

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.

Regulatory Associate/Sr Regulatory Associate /Manager, GRA, Canada

Location: Greater Toronto Area

Purpose

The purpose of the Canada affiliate regulatory role is to manage the operational and technical aspects of regulatory affairs for the Canada marketing affiliate including:

Execute the Regulatory Plan/objectives to ensure the success of new product registrations, 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
Foster an environment of operational excellence and collaborate with cross functional teams to successfully achieve affiliate regulatory objectives
Facilitate and cultivate relationships with the local regulatory agencies and trade associations

This role is determined to be a flexible worker, where on-site presence in the Toronto office is expected to be 10 days per month, as determined by your manager and business needs.

Qualifications

At Lilly Canada, there are three levels available based on the candidates experience, background, and qualifications. For transparency, the ranges for this position are:

Associate: $64,875 - $95,150
Sr Associate: $79,500 - $116,600
Manager: $100,500- $147,400

This role is eligible for additional forms of compensation, such as participation in the Lilly Bonus Program.

This posting is for an existing vacancy.

Primary Responsibilities

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Regulatory Plan Execution

Implement the Regulatory Plan in alignment with affiliate business plans as well as with regulatory requirements.
Ensure submission and approval of high quality regulatory applications within planned timeframes. Maintain or support maintenance of clear metrics for regulatory deliverables.
- Preparation and support of new applications to obtain marketing authorisations
- Voicing affiliate perspective and needs to global and regional regulatory contacts
- Ensuring timely responses to requests from support groups and/or regulatory authorities
- Maintaining marketing authorisations (timely submission of post-approval maintenance activities like renewals, variations and periodic reports)
Maintain regulatory tools in alignment with defined compliance metrics
Support affiliate launch teams anticipating potential regulatory constraints and delivering regulatory outcomes to support the affiliate launch plans
Represent the regulatory affairs function as appropriate in brand teams and New Product Planning discussions
Maintain awareness of current regulations and anticipate implications and opportunities of changes in the regulatory environment. Communicate changes to appropriate management and cross-functional experts as appropriate and implement locally
Support 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
Facilitate interactions with regulatory bodies on a regular basis
Support the implementation of any additional risk minimization measures at the affiliate and ensure appropriate metrics are generated

Labelling

Perform the function of Primary, Delegate or Alternate Affiliate Labelling Responsible Person (ALRP), ensuring that Product Information complies with local regulatory requirements and that updated Product Information is submitted, approved and implemented within the designated internal and/or regulatory authority timeframes
Ensure adherence with global labelling procedures and document relevant exceptions Regulatory Compliance
Ensure that internal regulatory IT tools and trackers are up to date and accurate
Ensure that all products comply with local regulations and quality system requirements whichever is more stringent
Ensure that the regulatory archive is complete and up to date and ensure that all current licenses and labels are readily available
Support internal audits / assessments / self-inspections / external inspections in collaboration with Medicines Quality Organisation and local Ethics and Compliance
Implement corrective/preventative actions as appropriate
Raise awareness to leadership and relevant functions on compliance issues and initiatives and provide technical support to other affiliate functions
Support implementation of local quality system in line with the global quality system and local regulations

Process Improvement

Ensure alignment and implementation of internal regulatory initiatives
Actively participate in affiliate cross-functional teams and provide regulatory input and knowledge
Support implementation of launch readiness initiativesBuild and maintain relationships with key regulatory officials and trade associations
Provide affiliate training and education on regulatory matters and provide regulatory input to affiliate strategic initiatives

Personal and Professional Development·

Support the Affiliate Regulatory leader internally and in interactions with Health Canada. Fully support and live Lilly’s ARS strategy.
Knowledge and understanding of local regulations and local, regional and global regulatory proceduresAttend appropriate external symposia, workshops or conferences to develop technical expertise

Minimum Qualification Requirements

Bachelor’s degree or equivalent in a relevant scientific subject
At least 1-3 year industry related experience in regulatory affairs and experience of dealing with external regulatory agencies, the health care system and marketing needs
Team working skills with special focus on results
Ability to adapt to challenging situations
Demonstrated good computer/IT skills
Bilingual proficiency (English/French) considered an asset

Other Information/Additional Preferences

Analytical, problem solving and negotiation skills
Good communication skills
Project management skills
Strong planning and priority setting
Knowledge of Quality systems

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

$64,870 - $147,400

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.

#WeAreLilly

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More about this job

Responsibilities

Execute Canadian regulatory plans and prepare, submit, and maintain marketing authorization applications, including new product filings, line extensions, variations, renewals, and periodic reports. Ensure compliant product labelling and regulatory records, support launches and inspections, engage with Health Canada and other stakeholders, and contribute to affiliate quality systems and process improvements.

Requirements

A bachelor’s degree or equivalent in a relevant scientific subject and at least 1–3 years of industry-related regulatory affairs experience, including engagement with external regulatory agencies, are required. Candidates should demonstrate teamwork, adaptability, computer skills, analytical and communication abilities, project management, planning, and knowledge of quality systems; English-French bilingual proficiency is an asset.

Skills

Regulatory Affairs
Regulatory Strategy
Regulatory Submissions
Health Canada Liaison
Product Labelling
Regulatory Compliance
Quality Systems
Project Management
Cross-Functional Collaboration
Analytical Problem-Solving
Negotiation
Communication
Planning and Prioritization
Regulatory Agency Relations
Process Improvement
Computer and IT Skills

Benefits

Company Bonus
Pension Plan
Vacation Benefits
Healthcare Benefits
Flexible Benefits
Life Insurance
Death Benefits
Time Off and Leave Benefits
Well-Being Benefits
Employee Assistance Program
Fitness Benefits
Employee Clubs and Activities

Visa sponsorship

Not detected in the job text

Keywords

Regulatory Affairs
Canada Affiliate
Regulatory Plan
Health Canada
Marketing Authorization
New Drug Submission
Clinical Trial Application
Regulatory Submissions
Post-Approval Maintenance
Variations
Renewals
Periodic Reports
Product Labelling
Regulatory Compliance
Quality Systems
Regulatory Archive
Internal Audits
Self-Inspections
Corrective and Preventive Actions
Risk Minimization Measures
Regulatory-HTA Interdependencies
CDA-AMC
pCPA
Pre-NOC SAP Access
Launch Readiness
New Product Planning
Trade Associations
Process Improvement
Regulatory Metrics

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