Regulatory Affairs Manager

2 months ago

Toronto, Ontario, Canada Deciem Full time

**Job Summary**

We are seeking a highly skilled Regulatory Affairs Manager to join our Scientific team at Deciem. This is a full-time, permanent position based out of our head-office.

**Key Responsibilities**

  • Provide regulatory guidance and strategy to R&D and business partners to support development of product programs.
  • Prepare, review, and file submissions for product registrations, 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.

**Product Labelling and Marketing**

  • Review and approve product labelling and websites for accuracy and compliance to both internal and external requirements.
  • Collaborate with internal departments to ensure that product claims and advertising are compliant and competitive.
  • Provide guidance in the submission of dossiers to advertising pre-clearance agencies to obtain approval for competitive consumer and professional advertising.

**Project Management**

  • Manage the regulatory affairs component of New Product Development work.
  • Prioritize and manage multiple, concurrent, and often global projects within the regulatory affairs team.
  • Communicate ingredient and finished product assessment results with external teams and ensure that the impact of the assessment is well understood.

**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.

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