Global Regulatory Expert

2 days ago

Navi Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 20,00,000

Join a leading pharmaceutical organization and embark on a challenging career as a Senior Manager.

The role involves overseeing global regulatory submissions, ensuring compliance with Emerging Market regulations, and managing project timelines. As a key member of the team, you will be responsible for driving efficiency in regulatory processes through digital tools and governance systems.

Key Responsibilities:

  • Develop and implement strategies for In-license product registration, variations, renewals, and life-cycle management.
  • Ensure compliance with Emerging Market regulatory guidelines.
  • Manage regulatory submissions (CTD, ACTD, eCTD dossiers) and timely responses to authority queries.
  • 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.
  • 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 to ensure project alignment.
  • Track project risks, implement mitigation strategies, and report progress to leadership.

Requirements:

  • In-depth knowledge of global regulatory frameworks (SFDA / GCC / PICs / BPOM / EAEU).
  • Proven track record of successful regulatory submissions and project execution.
  • Excellent 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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