Regulatory Associate Director for Global Biologics
4 weeks ago
Transforming Patients' Lives Through Science
At Bristol Myers Squibb, we're dedicated to creating innovative solutions that improve patients' lives. As a key member of our Global Regulatory Sciences team, you'll play a vital role in ensuring the quality and integrity of our biologics products.
Key Responsibilities
- Develop and maintain regulatory strategies for biologics products, ensuring compliance with global regulations and guidelines.
- Collaborate with cross-functional teams to assess and mitigate risks associated with manufacturing change controls.
- Interface with health authorities to address CMC-related issues and ensure timely submissions.
- Provide strategic guidance on regulatory requirements and expectations for small molecule marketing applications, clinical trial applications, and lifecycle changes.
- Identify and communicate complex issues to stakeholders, proposing effective resolutions.
Requirements
- 7-10+ years of pharmaceutical industry experience, with a strong background in CMC regulatory strategy.
- Knowledge of CMC regulatory requirements during development and post-approval, as well as experience with global CMC regulations for small molecule products.
- Ability to develop and maintain strong working relationships with regulatory teams and cross-functional stakeholders.
- Proficient with electronic systems and capable of prioritizing multiple complex projects.
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Hyderabad, Telangana, India Bristol Myers Squibb Full timeTransforming Patients' LivesBristol Myers Squibb is a leading pharmaceutical company dedicated to transforming patients' lives through science. As a key member of our Global Regulatory Sciences team, you will play a critical role in ensuring the quality and compliance of our biologics products. This includes developing, compiling, maintaining, and...
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