Regulatory Submission Expert
11 hours ago
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 yearWe 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.
- 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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