Regulatory Sciences Associate Director

1 week ago

Hyderabad, Telangana, India Bristol Myers Squibb Full time

Transforming Patients' Lives through Science

Bristol Myers Squibb is a leading pharmaceutical company dedicated to transforming patients' lives through science. We are seeking a highly skilled Regulatory Sciences Associate Director to join our team.

The successful candidate will be responsible for developing and implementing regulatory strategies for our biologics products, ensuring compliance with global regulations and guidelines. This role will involve working closely with cross-functional teams to ensure timely and accurate submissions to regulatory authorities.

Key Responsibilities

  • Develop and implement regulatory strategies for biologics products
  • Ensure compliance with global regulations and guidelines
  • Collaborate with cross-functional teams to ensure timely and accurate submissions
  • Assess manufacturing change controls for global impact
  • Guide technical teams on practical aspects of global change management

Requirements

  • 7-10+ years of pharmaceutical industry experience, including multi-disciplined experience
  • Knowledge of CMC regulatory requirements during development and post-approval
  • Experience with global CMC regulations for small molecule products
  • Demonstrated ability to develop/maintain strong working relationships with regulatory teams

What We Offer

Bristol Myers Squibb offers a unique and inclusive work environment, with opportunities for professional growth and development. We are committed to diversity, equity, and inclusion, and strive to create a workplace where everyone feels valued and respected.

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