Replacement position for GM / Sr GM / EGM

Position Overview

JOB DESCRIPTION

The AVP - Regulatory Affairs for Complex Sterile Products (Pre-Approval Domain) will serve as a strategic regulatory leader responsible for global regulatory strategy, team leadership, and end-to-end execution of regulatory activities for development, registration, and lifecycle management of complex sterile products. The role ensures business-aligned regulatory excellence, global compliance, and timely approvals in key markets (US, Canada, EU, and emerging markets

Key Responsibilities

• Build, develop, and lead a high-performing, globally oriented regulatory affairs team focused on complex sterile product development.
• Foster a culture of regulatory innovation, accountability, and compliance within a high-paced development environment.
• Provide mentorship to regulatory professionals across levels and guide cross-functional teams on the latest regulatory pathways, digital submission platforms, and risk-based decision frameworks.
• Define, lead, and execute global regulatory strategies for new product filings including DMF, ANDA, NDA, ANDS, NDS, MAA, and hybrid applications.
• Partner with Clinical, R&D, CMC, Quality, IP, and Commercial teams to drive regulatory alignment from early development to commercialization.
• Champion early-phase regulatory input to ensure product design and development is aligned with regulatory expectations and technical feasibility.
• Serve as the primary regulatory interface with global health authorities (FDA, EMA, Health Canada, TGA, WHO PQ, SFDA, etc.), leading key milestone meetings and scientific advice sessions.
• Lead end-to-end authoring, review, and submission of regulatory dossiers using eCTD formats and digital regulatory platforms.
• Oversee regulatory lifecycle including post-approval supplements, variations, renewals, labeling updates, and annual reports, ensuring GxP compliance.
• Monitor evolving global regulatory landscapes, maintaining an internal regulatory intelligence database and proactively adapting strategies.
• Identify and address regulatory risks through robust mitigation strategies, regulatory precedents, and scientific justification.
• Lead the preparation and strategic responses to complex queries, complete response letters (CRLs), and deficiency letters from health authorities.
• Represent the regulatory function in due diligence, portfolio reviews, strategic collaborations, and BD&L evaluations for sterile technologies.
• Drive regulatory innovation through digitalization, automation tools, AI-supported writing platforms, and analytics to enhance dossier quality and submission speed.
• Ensure audit readiness and actively support internal/external audits, mock inspections, and health authority inspections globally.
• Champion regulatory governance, metrics tracking, and process improvements to enhance team performance and alignment with KPIs.
  
  

Qualifications & Experience

• Advanced degree in Pharmacy, Life Sciences, Regulatory Affairs, or related field (M. Pharm/PhD preferred).
• 18+ years of relevant experience in regulatory affairs, specifically in sterile and complex injectables.
  
  

Skills & Competencies

• Deep knowledge of pharmaceutical regulatory requirements and guidelines (ICH, FDA, EMA, Health Canada).
• Strong project management and organizational skills.
• Excellent written and verbal communication.
• Decisive, proactive, and solution-oriented mindset.
• Ability to influence without authority and manage regulatory conflicts effectively.
• High attention to detail with a commitment to quality and compliance.
  
  

Preferred Experience

Experience with complex sterile products including liposomes, emulsions, suspensions, drug -device combination products or peptide-based injectables.

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.