Senior Regulatory Project Manager

1 day ago

Mumbai, Maharashtra, India beBeeCompliance Full time ₹ 1,50,00,000 - ₹ 2,50,00,000
Regulatory Affairs Manager

About the Role:

This senior position oversees regulatory projects and collaborations, developing innovative approaches to compliance and ensuring timely product approvals.

Key Responsibilities:

  • Lead preparation and submission of registration dossiers, supplements, and amendments.
  • Interact with regulatory agencies for product approvals.
  • Serve as a liaison throughout the product lifecycle, ensuring compliance with global and local regulations.
  • Contribute to product planning and implementation, including regulatory strategy, risk management, and CMC.
  • Ensure timely approval of new products and continued approval of marketed products.
  • Advise cross-functional teams on regulatory requirements, technical labeling, and interpretation of applicable regulations.
  • Monitor and assess regulatory changes, providing guidance to stakeholders on potential business impact.

Requirements:

  • Bachelor's or Master's degree in a relevant field.
  • Minimum 7 years of experience in Regulatory Affairs, with demonstrated expertise in submissions and agency interactions.
  • Strong understanding of global and local regulatory guidelines.
  • Experience in drug development, biologics, or medical devices preferred.

Skills & Competencies:

  • Deep knowledge of regulatory requirements and processes.
  • Excellent project management, analytical, and problem-solving skills.
  • Strong written and verbal communication skills for effective interactions.
  • Ability to work independently while collaborating with cross-functional teams.

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