Regulatory Affairs Expert: Lead Product Safety and Compliance

1 week ago


Toronto, Ontario, Canada Deciem Full time
About the Role

We are seeking a seasoned Senior Manager to lead our Regulatory Affairs team in ensuring compliance with product safety and regulatory requirements. As a key member of our Scientific team, you will be responsible for managing the submission and approval process for new products.

Key Responsibilities
  • Provide strategic guidance on regulatory affairs to R&D and business partners to support development of product programs.
  • Prepare, review, and file submissions for ANDA/ANDS, NDA/NDS, IND, and DMF in the eCTD format, as well as Rx to OTC Switches.
  • Determine and communicate submission and compliance requirements to stakeholders within the company.
  • Manage approval of assigned new products and claims, manage changes to existing products, and maintain compliance with applicable government regulations.
Skills and Qualifications
  • University degree in a scientific field (Life Sciences, Chemistry, Pharmacology/Toxicology or Pharmacy).
  • 10+ years of experience in regulatory affairs, including direct experience in submission and shepherding of product registrations for drug products, focusing on Canadian, USA, UK, and European Union regulatory schemes.
  • 5+ years of leadership or management experience.
  • Demonstrated proven record of negotiating product approvals with regulators and innovating regulatory strategies.
Salary and Benefits

This role offers an estimated annual salary range of $120,000 - $180,000, commensurate with experience. Additionally, you will receive comprehensive benefits, including generous vacation and personal days, 6 months of paid parental leave, work-from-anywhere options, and more.

About Us

At Deciem, we value innovation and employee growth. We offer unlimited access to LinkedIn Learning, professional development grants, and an Employee Assistance Program. Join our team and take your career to the next level.



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