Senior Regulatory Affairs Manager

  • Department: Regulatory Affairs
    Reports to: Pharmaceutical Affairs Director 

    Responsibilities:
    • Managing and overseeing Regulatory activities/tasks and strategy for North America, Latin America, and Asia Pacific Regions
    • Manage, review, critique, and approve regulatory submission filings for regional regulatory authorities (especially Canada and USA). Ensure submissions are filed on timely basis ; regulatory gaps and/or deficiency responses are pre-planned and addressed; and submission approvals are obtained/received as planned.
    • Manage the regulatory lifecycle for approved products
    • Work with corporate product development, regulatory, and quality team to ensure CMC portions of the marketed product dossiers are updated and kept current.
    • Work with Corporate Regulatory Affairs to ensure submissions and labeling are kept current in the regulatory information management system.
    • Manage regulatory responsibility for all clinical studies performed in the region as required.
    • Plan and control budgetary expenditures within the regulatory department
    • Identify and implement improvement activities related to regulatory compliance, cost and cycle time.
    Qualifications:
    • Minimum BSc. Science degree (Chemistry, Microbiology, or Pharmacy)
    • Minimum 5 years regulatory affairs management experience in submission creation and filing within the pharmaceutical industry; experience in filing submissions and obtaining approvals within Canada and USA
    • Capable of leading, managing, motivating and engaging employees to perform as a united team to achieve individual and team goals and objectives
    •  Experienced in negotiations and addressing deficiencies with regulatory authorities