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Amneal Pharmaceuticals - Manager - Clinical Regulatory Affairs

Amneal Pharmaceuticals - Manager - Clinical Regulatory Affairs

AMNEAL PHARMACEUTICALS PRIVATE LIMITEDAhmedabad,Gujarat, India
27 days ago
Job description

Role Overview :

  • The Regulatory Affairs Manager will serve as the strategic and operational leader for all global regulatory submissions, ensuring compliance and execution excellence across 505(b)(2), ANDAs, NDAs, and international marketing authorizations (EU, UK, and other global markets). This role requires deep expertise in regulatory strategy, cross-functional leadership, and the ability to drive submission readiness from product development through commercialization.
  • The incumbent will act as the regulatory authority within the organization, setting direction, ensuring compliance, and enabling business success through proactive engagement with internal stakeholders and external regulatory agencies.

Key Responsibilities :

Strategic Leadership :

  • Define, develop, and implement regulatory submission strategies for 505(b)(2), ANDAs, NDAs, and international markets.
  • Provide regulatory leadership and decision-making support to senior management and global project teams.
  • Interpret global regulations, guidelines, and industry trends to influence internal strategies and business decisions.
  • Serve as the key liaison with health authorities, leading interactions, negotiations, and response strategies.

    • Regulatory Execution & Oversight :

  • Lead the planning, authoring, review, and approval of all regulatory submissions, ensuring accuracy, compliance, and timely delivery.
  • Oversee preparation and approval of high-quality documentation across Clinical Development, Non-Clinical Development, R&D, Quality, Technical Operations, and Labeling.
  • Ensure effective management of timelines, proactively identify risks, and drive mitigation strategies to meet submission goals.
  • Approve critical regulatory documents, ensuring alignment with both global regulatory expectations and business objectives.

    • People & Stakeholder Management :

  • Lead, mentor, and manage cross-functional regulatory teams, external consultants, and vendors to deliver on submission milestones.
  • Partner with internal stakeholders including R&D, Quality, Technical Operations, and Commercial to ensure regulatory alignment throughout the product lifecycle.
  • Act as the escalation point for regulatory issues, providing clear direction and resolution paths.
  • Foster a culture of accountability, compliance, and continuous improvement within the regulatory function.

    • Governance & Compliance :

  • Establish and enforce regulatory processes, policies, and best practices across global submissions.
  • Ensure the organization meets all regulatory and quality standards across markets.
  • Drive compliance reviews, audits, and corrective action planning where required.
  • Monitor regulatory changes and proactively adapt company strategies to remain compliant and competitive.

    • Required Skills & Competencies :

  • Regulatory Strategy Development - Expert level; proven ability to lead global submission strategies.
  • Global Regulatory Submissions Management - Advanced proficiency with 505(b)(2), ANDAs, NDAs, EU / UK Marketing Authorizations.
  • Documentation Review & Approval - Strong leadership in ensuring quality, accuracy, and compliance.
  • Cross-Functional Leadership - Ability to lead diverse teams across functions and geographies.
  • Regulatory Intelligence - Skilled in interpreting regulations, anticipating changes, and shaping business Advanced degree in Pharmacy, Life Sciences, or related field (Pharm.D, M.Pharm preferred).
  • MBA in operations with be a plus
  • Minimum 10+ years of progressive regulatory affairs experience with at least 3+ years in a management / leadership role.
  • Demonstrated track record of successful global regulatory submissions and approvals.
  • Strong leadership, decision-making, and stakeholder management skills.

    • (ref : iimjobs.com)

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