Senior Manager, Regulatory Affairs, Product Safety Expert

4 weeks ago

Toronto, Ontario, Canada Deciem Full time

We are seeking a highly skilled Senior Manager, Regulatory Affairs, Product Safety to join our Scientific team at DECIEM. This role will be based out of our head-office in Liberty Village.

Key Responsibilities:

  • Provide regulatory guidance and strategy to R&D and business partners to support development of product programs.
  • Prepare, review, and file 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 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, in collaboration with legal and marketing.

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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