Global Regulatory Operations Senior Executive

12 hours ago

Navi Mumbai, Maharashtra, India upl limited Full time ₹ 20,00,000 - ₹ 25,00,000 per year
Job Description

Global Regulatory Operations Senior Executive - APAC

Job Id: 11870
City: Navi Mumbai, Maharashtra, India
Department: Regulatory
Function: Regulatory Science & Government Affairs
Employee Type: Permanent Full Time
Seniority Level: Executive

Description:

Job Summary: The Regulatory Operations Specialist will be responsible for managing and executing regulatory strategies, submissions, and compliance activities across the Asia-Pacific (APAC) region. This role ensures that products meet all regulatory requirements for market access, lifecycle management, and post-market surveillance. The position involves cross-functional collaboration, regulatory intelligence monitoring, and direct engagement with health authorities.

Key Responsibilities:

Regulatory Strategy & Execution

  • Develop and implement regulatory strategies for product registration and lifecycle management across APAC.
  • Monitor and analyze regulatory changes and assess their impact on product portfolios.
  • Advise internal stakeholders on regulatory requirements during development, launch, and post-approval phases.

Regulatory Submissions & Compliance

  • Prepare and manage regulatory dossiers for new products, renewals, and variations.
  • Ensure timely submission and approval of regulatory filings in compliance with local and international regulations.
  • Oversee post-market activities including adverse event reporting, product recalls, and labeling compliance.

Cross-Functional Collaboration

  • Work closely with R&D, Quality, Legal, and Commercial teams to align regulatory actions with business goals.
  • Represent the company in meetings with regulatory agencies, industry associations, and external consultants.

Regulatory Intelligence & Documentation

  • Track emerging regulatory trends and provide proactive guidance to mitigate risks.
  • Maintain organized records of submissions, approvals, and correspondence.
  • Prepare regulatory reports and updates for internal stakeholders.

Apply now

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