Job Description

• To act as the strategic leader for regulatory affairs, driving global and India regulatory strategies for NCE development through the 505(b)(2) pathway.

• To oversee end-to-end regulatory submissions, ensure compliance with CDSCO and international agencies, and serve as the primary liaison with health authorities.

• To collaborate closely with R&D, clinical, and commercial teams to integrate regulatory requirements into development plans while mentoring a high-performing regulatory team.

• To lead regulatory strategy and execution for New Chemical Entities (NCEs), focusing on 505(b)(2) submissions for India and global markets. This role involves end-to-end regulatory planning, liaison with local and international health authorities (CDSCO, USFDA, EMA, etc.), and ensuring compliance throughout the product lifecycle. The position also requires strong collaboration with cross-functional teams and oversight of regulatory intelligence to support business objectives.

• Regulatory Strategy & Submissions

• Develop and implement global regulatory strategies for NCEs, including 505(b)(2) pathways.
• Oversee preparation, review, and submission of dossiers (IND, NDA, ANDA, MAAs) in eCTD format for India and international markets.
• Ensure timely filing and approval of regulatory submissions in compliance with ICH, USFDA, EMA, and CDSCO guidelines.

• Global & Local Liaison

• Act as the primary point of contact with CDSCO and global regulatory agencies.
• Represent the company in regulatory meetings, scientific advice sessions, and negotiations with authorities.
• Maintain strong relationships with local affiliates and global partners to ensure alignment on regulatory requirements.

• Compliance & Governance

• Monitor regulatory changes and assess their impact on company products and processes.
• Ensure adherence to GxP standards, pharmacovigilance requirements, and post-marketing commitments.
• Drive internal audits and readiness for health authority inspections.

• Cross-functional Collaboration

• Work closely with R&D, Clinical, CMC, Quality, and Commercial teams to integrate regulatory requirements into development plans.
• Provide regulatory guidance during product development, clinical trials, and commercialization phases.

• Regulatory Intelligence

• Stay updated on global regulatory trends, guidelines, and competitive intelligence.
• Advise senior leadership on regulatory risks and opportunities impacting business strategy.

• Leadership & Team Development

• Lead and mentor the regulatory affairs team to build expertise in global and local regulatory frameworks.
• Foster a culture of compliance and continuous improvement.

M. Pharm

Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.