Drive regulatory strategies as the Associate Director of Regulatory Affairs in a leading Indian pharmaceutical company. Focus on Abbreviated New Drug Submissions to ensure product approvals and market readiness.
This significant role encompasses 15–20 years of experience in regulatory affairs, commanding a strategic approach to product development and Health Canada interactions. You will lead the regulatory processes for ANDS and supplemental filings, engaging closely with cross-functional teams to align goals and maximize product portfolios.
Key Responsibilities:
• Develop regulatory strategies for ANDS submissions
• Liaise with Health Canada for regulatory discussions
• Prepare and submit ANDS and SANDS filings
• Guide senior management on regulatory landscapes
• Mentor and lead a small team of regulatory associates
Requirements:
• Advanced degree in Pharmacy or related discipline
• 15–20 years' experience in pharmaceutical regulatory affairs
• Extens...