Deputy General Manager, Regulatory Affairs | NCE

Amneal Pharmaceuticals

Website: amneal.com
Job details:
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.
  
  

Qualifications

M. Pharm

About Us

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.

About The Team

The Human Resources team partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs.

Key Roles That The Human Resources Team Performs

Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions.

Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures.

Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing.

Consultancy Role: Provide expert advice to the organization and it’s managers on any aspect of workforce management and employee relations and performance.

Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market. Click on Apply to know more.