Strategic Pharmaceutical Executive

2 days ago

Navi Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 2,00,00,000 - ₹ 2,50,00,000

About us:

We are a multinational pharmaceutical company headquartered in Mumbai, manufacturing and selling pharmaceutical generics, formulations, and nutraceuticals in India and globally.

Our portfolio includes illustrious brands like Clavam, Pan, Pan-D, and Taxim-O.

We are seeking a Senior Manager to develop and implement emerging market strategies for in-license product registration, variations, renewals, and life-cycle management.

This role involves ensuring compliance with emerging market regulatory guidelines, managing regulatory submissions (CTD, ACTD, eCTD dossiers), and responding to authority queries in coordination with DRA.

The ideal candidate will have strong leadership, stakeholder management, and communication skills, with experience in global submissions and product lifecycle management.

Key Responsibilities:

  • Develop and implement Emerging Market 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 for Inlicensing products in coordination with DRA.
  • Liaise with country RA teams & health authorities, external consultants, and industry associations for smooth regulatory interactions for Inlicensing products.
  • 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.
  • Drive efficiency in regulatory & project processes through digital tools, dashboards, and governance systems.

Required Skills & Qualifications:

  • In-depth knowledge of global regulatory frameworks.
  • 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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