At Adalvo, we're not just a company - we're a team of passionate people driven by our mission to consistently deliver high-quality products and services to our partners. We are positive, rapid and always on target, we are Adalvo ? ?

We are looking for an enthusiastic VP, Regulatory Affairs to join our dynamic Quality team. If you're someone who thrives in a fast-paced environment and loves tackling new challenges, then this is the perfect opportunity for you.

SUMMARY OF POSITION

The Vice President (VP) of Regulatory Affairs (Generics & Specialty Generics) is responsible for driving the strategic
planning, preparation, and successful execution of regulatory submissions across the United States and Canada. This leadership role focuses heavily on generic drug pathways, including 505 (b)2, Abbreviated New Drug Applications (ANDAs) via the US FDA Office of Generic Drugs (OGD) and New Drug Submissions (NDS) and Abbreviated New Drug Submissions (ANDS) via Health Canada's Health Products and Food Branch (HPFB). The VP will oversee a diverse portfolio of complex generic products (e.g.,



sterile injectables, topicals, and pens), ensuring strict compliance with GDUFA requirements, managing Paragraph IV patent certifications, and leading critical interactions with regulatory health authorities.

KEY RESPONSIBILITIES

Regulatory Strategy & Pipeline Execution: Develop and implement innovative global regulatory strategies for complex and specialty generic products to ensure rapid, first-cycle approvals in the US and Canada.
Submission Leadership: Oversee the compilation, review, and high-quality electronic submission (eCTD) of ANDAs to the US FDA and ANDSs to Health Canada, ensuring absolute scientific accuracy and compliance.
Portfolio Management: Guide regulatory pathways for specialty generics, including Competitive Generic Therapies (CGT), drug-device combinations, and complex dosage forms (injectables, topicals, combination products, pens).
Patent & Legal Collaboration: Part

📌 Vice President Regulatory Affairs (Mumbai)
🏢 Adalvo
📍 Mumbai