Regeneron

Regeneron

Senior Manager Regulatory Affairs

Toronto · Senior

Sponsorship not specifiedDetected 2 days ago
FDA RegulatoryCollaborationProblem SolvingRegulatory Affairs

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Cap-exempt (no lottery)0
Sponsors this role82
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70

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About the role

  • Serve as primary Canadian authority contact, leading meetings for assigned projects.
  • Represent Regulatory Affairs on cross-functional teams.
  • Ensure Canadian regulatory and local standards compliance; monitor Health Canada policy, regulation and guidance changes, providing comments.

Responsibilities

  • Build our future together:
  • In this role, you will develop globally aligned regulatory strategies throughout product development while collaborating with global regulatory and product teams.
  • Develop high-quality, globally aligned regulatory strategies throughout relevant product development stages.
  • Develop local labelling and patient information; approve promotional and non-promotional materials against regulatory requirements.

Requirements

  • Scientific bachelor's degree; advanced degree preferred.

Compensation

  • Where necessary, we disclose salary ranges for roles in all countries in which we operate.

Benefits

  • Experience leading face-to-face Health Canada meetings and new product launches.
  • This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
  • Manage timely Health Canada clinical trial, marketing application and post-approval submissions.
  • Support Health Canada Drug Establishment License activities and local/global process development.

Company info

  • We are seeking a Senior Manager, Regulatory Affairs to join our Regulatory Affairs team, supporting our Canadian projects in a hybrid setting.
  • Please be advised that at Regeneron, we believe we do our best work when we are together.
  • As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based.
  • At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases.

Visa & Work Authorization

  • ignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status
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This listing is sourced directly from Regeneron's careers page and normalized into a canonical job model.