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

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.

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.

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