Regulatory Affairs Associate — Canada (Bonus Eligible)

Eli Lilly and Company; Toronto; Presencial; CAD 80.000 - 147.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Lilly Bonus Program

Descripción de la vacante

Eli Lilly and Company in Canada is seeking a Regulatory Associate/Sr Regulatory Associate/Manager, GRA, Canada in the Greater Toronto Area to lead regulatory plans for new product registrations and line extensions while ensuring compliance.

The role collaborates with cross-functional teams, maintains regulatory tools, and communicates with Health Canada and other authorities. Eligible for Lilly Bonus Program and related compensation.

Formación

• Bachelor’s degree or equivalent in a relevant scientific subject.
• At least 1-3 years of industry related experience in regulatory affairs.
• Team working skills with emphasis on results.
• Ability to adapt to challenging situations.
• Demonstrated good computer/IT skills.
• Bilingual proficiency (English/French) considered an asset.

Responsabilidades

• 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.
• 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.
• Support Health Canada CTA and NDS/submission strategy for Canada.
• Maintain awareness of regulatory-HTA interdependencies to inform submission sequencing and affiliate planning.
• Facilitate interactions with regulatory bodies on a regular basis.
• Support implementation of any additional risk minimization measures at the affiliate.

Conocimientos

Team working skills

Adaptability

Good computer/IT skills

Bilingual English/French

Educación

Bachelor’s degree or equivalent in a relevant scientific subject

Descripción del empleo

Eli Lilly and Company in Canada is seeking a Regulatory Associate/Sr Regulatory Associate/Manager, GRA, Canada in the Greater Toronto Area to lead regulatory plans for new product registrations and line extensions while ensuring compliance.

The role collaborates with cross-functional teams, maintains regulatory tools, and communicates with Health Canada and other authorities. Eligible for Lilly Bonus Program and related compensation.