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
