Regulatory Affairs Director

3 days ago

Mumbai, Maharashtra, India beBeeDirector Full time ₹ 2,00,00,000 - ₹ 2,50,00,000
Job Description

The role involves developing and executing regulatory strategies to ensure product compliance, acting as a key liaison with regulatory agencies, and collaborating with cross-functional teams.

Key Responsibilities include:

  • Submission Management: Preparation, review, and submission of regulatory documentation to health authorities in various regions.
  • Import License/Registration: Ensure products and processes consistently adhere to national and international regulations and standards.
  • Regulatory Intelligence: Monitor and interpret changes in regulatory legislation and guidelines, providing actionable insights to internal teams and leadership.
  • Cross-Functional Collaboration: Work with R&D, manufacturing, quality assurance, and commercial teams to align product development and lifecycle management with regulatory requirements.
  • Documentation Management: Maintain accurate and comprehensive regulatory databases, files, and records.

The ideal candidate will have in-depth knowledge of regulatory affairs for drug products, nutraceuticals, and health supplements. They should possess strong analytical and communication skills, be able to lead cross-functional teams, and have a deep understanding of regulatory guidelines.

Required Skills and Qualifications
  • In-depth knowledge of regulatory affairs for drug products, nutraceuticals, and health supplements.
  • Strong ability to analyze regulatory issues, troubleshoot, and develop pragmatic solutions.
  • Excellent verbal and written communication skills to effectively interact with regulatory bodies, internal stakeholders, and external customers.
  • Strong organizational skills and the ability to manage multiple priorities and projects simultaneously.

This position offers an exciting opportunity to work closely with cross-functional teams and contribute to the development and implementation of regulatory strategies that drive business growth.

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