Regulatory Affairs Leader - Pharmaceuticals

Lead with expertise as Associate Director of Regulatory Affairs at a rapidly expanding pharmaceutical firm in Bengaluru. This role requires a focus on regulatory strategies for successful product submissions.
In this senior role, you will oversee regulatory operations with a special emphasis on ANDS and supplemental ANDS submissions. With 15–20 years of regulatory experience, you will interface with Health Canada to facilitate approvals, ensuring compliance with evolving regulations and corporate objectives.
Key Responsibilities:
• Develop and implement regulatory strategies for timely approvals
• Act as primary liaison with Health Canada
• Prepare regulatory submissions for ANDS and post-approval filings
• Evaluate regulatory opportunities for portfolio optimization
• Mentor regulatory associates in submission processes
Requirements:
• Advanced degrees in relevant life sciences or pharmacy
• Minimum 15 years in regulatory affairs for pharmaceuticals
• ...