Manager- International Regulatory Lead

Job Description:

Responsibilities

• Provide Guidance and Leadership on mechanisms to optimize product development and regulatory approvals.
• Develop the international regulatory strategy and contribute to Global regulatory plans.
• Support regulatory product compliance (e.g. RIM, PMCs, ESC levels, and agency commitments).
• Support and advise on the local label strategy and alignment to cCDS/reference label.
• Build effective relationships and communication paths across global, regional, local and functional organizations.
• Enable efficiencies and seamless execution across the international countries.
• Contribute to process improvement projects, as assigned.

Qualification & Experience

• Doctorate degree and 6 years of directly related experience
• OR
• Master’s degree and 8 years of directly related experience
• OR
• Bachelor’s degree and 10 years of directly related experience
• Education & Experience (Preferred)
• Degree and in-depth regulatory experience and/or related to the region.
• In-depth knowledge of regional countries legislation and regulations relating to medicinal products.