Global Regulatory Strategist

7 days ago


Daman, Daman and Diu, India beBeeRegulatoryAffairs Full time ₹ 20,00,000 - ₹ 25,00,000
Regulatory Affairs Manager Job Overview

This role focuses on spearheading the development and implementation of global regulatory strategies to ensure timely product approvals and market access across multiple health authorities.

  • The successful candidate will develop, implement, and manage global regulatory strategies to ensure timely product approvals and market access in various health authorities.
  • Provide expert regulatory advice to senior management on evolving regulations and their impact on business goals.
  • Collaborate with cross-functional teams, including R&D, Quality, Manufacturing, and Marketing, to align regulatory activities with overall business objectives.

In addition, you will be responsible for preparing and submitting Controlled Correspondence, Pre-submission Meeting Requests, and Scientific Advice for global markets. Furthermore, you will evaluate pre-PIFs and provide regulatory submission requirements for US and EU, with extended submissions for other regions.

Required Skills and Qualifications
  • Proven expertise in developing and implementing global regulatory strategies.
  • Strong knowledge of regulatory affairs principles, laws, and regulations in multiple regions.
  • Excellent communication and collaboration skills to work effectively with cross-functional teams.
Benefits

This position offers a unique opportunity to contribute to the success of our organization by shaping global regulatory strategies and ensuring timely product approvals and market access.

Additional Responsibilities

As a Regulatory Affairs Manager, you will have the opportunity to work closely with various stakeholders to drive business growth and achieve regulatory compliance.



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