Regulatory Submission Expert

11 hours ago


Hyderabad, Telangana, India Bristol Myers Squibb Full time
Transformative Regulatory Solutions at Bristol Myers Squibb

Bristol Myers Squibb is an innovative leader in the pharmaceutical industry, dedicated to creating a brighter future for patients worldwide. Our mission is to deliver transformative medications that improve lives and expand possibilities.

Salary Range: $80,000 - $120,000 per year

We are seeking a highly skilled Regulatory Submission Expert to join our team in Hyderabad, India. As a key member of our submission management group, you will play a critical role in ensuring timely, compliant, and accurate delivery of regulatory documents and dossiers to health authorities.

Job Responsibilities:
  • Provide expert advice on regulatory requirements, dossier content, and format using in-depth knowledge of eCTD submission production.
  • Support the execution of the Global Submission Plan through collaboration with team members and vendors.
  • Track progress of all components for submission to Health Authorities.
  • Facilitate submission team meetings and provide direction to ensure quality results.
  • Interact with responsible parties to ensure timely receipt of components and provide guidance on quality results.
  • Support research for legal due diligence activities, document and submission management for acquisitions, partnerships, and divestitures.
Key Qualifications:
  • Bachelor's degree in a science or technology field.
  • Minimum 5 years of relevant submissions experience.
  • Proficient knowledge of global regulatory practices, submission guidelines, and requirements.
  • Critical thinking skills to analyze complex situations and develop effective solutions.

Please note that this position requires excellent communication and project management skills, with a strong ability to collaborate with cross-functional teams.



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