Regulatory Submission Expert
7 days ago
Transformative Opportunity
Bristol Myers Squibb is a pioneering global biopharmaceutical company that pushes the boundaries of medical innovation. Our mission is to deliver transformative medicines that change the lives of patients worldwide.
We are seeking a highly skilled Regulatory Submission Expert to join our team in Hyderabad, India. This exciting opportunity will allow you to leverage your expertise in regulatory affairs and submission management to contribute to the development of life-changing treatments.
About the Role
The successful candidate will be responsible for coordinating the timely, compliant, and accurate delivery of submission documents and dossiers to health authorities. Key responsibilities include:
- Providing advice on regulatory and submission requirements, dossier content, and format using in-depth knowledge of eCTD submission production.
- Supporting the execution of the Global Submission Plan through collaboration with team members and vendors.
- Tracking progress of all components for submission to Health Authorities.
- Facilitating submission team meetings and interacting with responsible parties to ensure quality results.
- Supporting research for legal due diligence activities, document and submission management for acquisitions, partnerships, and divestitures.
Requirements
To succeed in this role, you will need:
- A BA/BS degree in a science or technology field (preferably).
- At least 5 years of relevant submissions experience.
- Proficient knowledge of global regulatory practices, submission guidelines, and requirements.
- Excellent communication and problem-solving skills.
Compensation Package
We offer a competitive salary of $120,000 per annum, along with a comprehensive benefits package, including health insurance, retirement savings plan, and paid time off.
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