Global Regulatory Strategy Director

4 days ago


Gurgaon, Haryana, India Sun Pharmaceutical Industries Full time

As a key member of our team at Sun Pharmaceutical Industries, the Global Regulatory Lead plays a pivotal role in shaping the company's regulatory strategy. The ideal candidate will have a deep understanding of global regulatory requirements and be able to develop and execute comprehensive strategies for product development, registration, and labeling.

The Associate Director will be responsible for formulating, developing, and executing a regulatory strategy that integrates US and ex-US regulatory requirements. They will work closely with product teams to provide strategic, tactical, and operational direction and guidance for assigned inline and pipeline assets. This includes developing and maintaining regulatory commitments and requirements, as well as retaining contemporary knowledge of regulations, directives, guidelines, and policies that impact product development.

The successful candidate will also act as a US agent, facilitating communications with health authorities and ensuring compliance with established procedures. Additionally, they will compile, prepare, and review regulatory submissions to regulatory agencies, conduct department-level training, and participate in authoring and reviewing departmental procedures.

  • A thorough understanding of drug development processes and regulatory requirements is essential
  • Direct experience authoring and filing clinical trial or marketing applications across major regulated markets is required
  • A strong background in biologics regulations is highly desirable


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