Senior Manager, Regulatory Affairs, Product Safety

1 month ago

Toronto, Ontario, Canada Deciem Full time
Job Title: Senior Manager, Regulatory Affairs, Product Safety

We are seeking a highly skilled and experienced Senior Manager to lead our Regulatory Affairs team in ensuring compliance with regulatory requirements for our product safety and toxicology portfolio.

Key Responsibilities:
  • Provide regulatory guidance and strategy to R&D and business partners to support development of product programs.
  • Prepare, review, and file regulatory submissions, including ANDA/ANDS, NDA/NDS, IND, and DMF in the eCTD format.
  • Determine and communicate submission and compliance requirements to key stakeholders within the company.
  • Manage and lead approval of assigned new products and claims, manage changes to existing products, and maintain products in compliance with applicable government regulations.
  • Develop and implement the global regulatory strategy for new product registrations and provide assessments and manage complaints from and to regulatory bodies and competitors.
Requirements:
  • University degree in a scientific field (Life Sciences, Chemistry, Pharmacology/Toxicology, or Pharmacy).
  • 10+ years of experience in regulatory affairs, including direct experience in the submission and shepherding of product registrations for drug products with a focus on Canadian, USA, UK, and European Union regulatory schemes.
  • 5+ years of leadership or management experience.
  • Demonstrated proven record of past achievement of negotiating product approvals with regulators and innovating regulatory strategies.
  • General understanding of the regulatory framework for cosmetics and personal care products.
What You'll Be Gaining:
  • Generous vacation and personal days, plus additional time off for volunteering in your community, voting, peaceful protesting, celebrating your birthday, and more.
  • 6 months of paid time off for new parents (inclusive of all genders).
  • Work from anywhere 4 weeks per year.
  • A hybrid work model (for applicable roles).
  • Summer Fridays - get off at 1pm all summer long (for applicable roles).
  • Unlimited access to an Employee Assistance Program that includes mental health care, mindfulness programs, and more.
  • Access to Development Grants & a LinkedIn Learning membership to help you keep growing and learning.
  • A generous discount on DECIEM products for you, your family, and your friends.

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