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

- 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

Qualifications

- 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.

- 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 recent 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 Qu

📌 Regulatory Associate/Sr Regulatory Associate (Toronto)
🏢 Eli Lilly
📍 Toronto