Regulatory Affairs Lead

22 hours ago

Gurgaon, Haryana, India beBeeRegulatoryAffairsManager Full time ₹ 1,04,000 - ₹ 1,30,878
Job Title: Senior Regulatory Affairs Manager

The role of the Senior Regulatory Affairs Manager is to serve as a high-level expert in regulatory affairs, overseeing the development and implementation of regulatory strategies for products. This includes interacting with regulatory agencies to expedite approval, serving as a liaison throughout the product lifecycle, and ensuring timely approval of new drugs, biologics or medical devices and continued approval of marketed products.

This is a senior leadership role that requires extensive knowledge and experience in regulatory affairs, with a focus on strategic planning and execution. The ideal candidate will have a strong background in regulatory strategy, risk management, chemistry manufacturing control (CMC), and has experience working in a fast-paced environment with multiple stakeholders.

Key Responsibilities:
  • Develop and implement regulatory strategies for products;
  • Interact with regulatory agencies to expedite approval;
  • Serve as a liaison throughout the product lifecycle;
  • Ensure timely approval of new drugs, biologics or medical devices and continued approval of marketed products;
  • Participate in product plan development and implementation, regulatory strategy, risk management, and CMC;
Qualifications:
  • Bachelor's Degree in a relevant field such as Life Sciences, Business Administration, or Law;
  • Minimum 7 years of experience in regulatory affairs, preferably in a senior leadership role;
  • Strong understanding of regulatory frameworks, policies, and procedures;
  • Excellent communication, negotiation, and project management skills;
  • Ability to work effectively in a team environment and manage competing priorities.

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