Global Regulatory Affairs Specialist

2 days ago

Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,00,00,000
Regulatory Affairs Specialist

We are seeking a highly skilled Regulatory Affairs Specialist to lead our global regulatory strategy and ensure compliance with regulatory guidelines.

This is an exciting opportunity for an experienced professional to take ownership of CMC regulatory submissions, ensuring timely delivery and adherence to regulatory requirements. Our ideal candidate will have a strong understanding of global regulatory landscapes and be able to provide strategic guidance on submission planning, authoring, and review.

  • Formulate and implement global CMC regulatory strategies that balance business objectives with regulatory compliance.
  • Develop and execute plans for CMC submissions, including project management, coordination, and quality assurance.
  • Author and review high-quality CMC documentation, applying knowledge of current regulatory trends and guidelines.
Requirements:
  • Proven experience in drug product development and commercialization.
  • Strong leadership and collaboration skills.
  • Excellent communication and negotiation skills.
  • Absorption and application of scientific knowledge to support regulatory decision-making.
  • Time management and prioritization skills.

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