Dynamic Pharmaceutical Executive

11 hours ago

Nashik, Maharashtra, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

Senior Manager Job Description

We are seeking an experienced Senior Manager to lead our regulatory affairs and project management efforts. The ideal candidate will have a proven track record of successful regulatory submissions and project execution.

About the Role:

  • Develop and implement strategies for in-licensed product registration, variations, renewals, and life-cycle management.
  • Evaluate emerging market regulatory guidelines and ensure compliance.
  • Manage regulatory submissions and responses to authority queries for in-licensed products.
  • Liaise with country RA teams, health authorities, external consultants, and industry associations for smooth regulatory interactions.
  • Monitor evolving regulatory environments and assess impact on business operations.
  • Ensure product labeling, packaging, and promotional material comply with applicable regulations.
  • Develop project timelines, budgets, and resource plans, ensuring on-time delivery.
  • Coordinate between R&D, QA, QC, Manufacturing, Supply Chain, and Commercial teams.
  • Track project risks, implement mitigation strategies, and report progress to leadership.
  • Drive efficiency in regulatory and project processes through digital tools, dashboards, and governance systems.

Key Skills & Competencies:

  • Proven knowledge of global regulatory frameworks.
  • Strong leadership, stakeholder management, and communication skills.
  • Ability to manage multiple projects under tight timelines.

Qualifications & Experience:

  • M.Pharm / M.Sc. (Pharmaceutical Sciences, Regulatory Affairs, or related field).
  • 10–14+ years of experience in pharmaceutical regulatory affairs and project management.
  • Demonstrated experience in global submissions and product lifecycle management.
  • Prior experience leading a regulatory/project team at a cluster or regional level preferred.

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