Nina Bhatt

About Nina Bhatt

As a Leader in regional Pharmaceutical Regulatory Affairs, I thrive at the intersection of strategic planning and regulatory compliance, bringing over a decade of experience in navigating complex regulatory landscapes and successful approvals of approximately 13 ANDAs and 3 NDA application. My core skills lie in regulatory submission lifecycles, change approval management, and FDA applications, including DMFs, INDs, NDAs, and ANDAs. I am passionate about creating a culture of collaboration and excellence, where innovative solutions are generated through teamwork and strategic insight. My approach is characterized by a proactive leadership style, where I advise senior executives on effective regulatory planning and data-driven strategies to achieve timely product approvals. I am committed to facilitating the approval process by ensuring cross-functional collaboration and providing on-site support during PAIs. My analytical problem-solving skills allow me to evaluate contract research organizations (CROs) effectively and advise leadership on regulatory strategy, ensuring compliant label design and adherence to local legislation. During my tenure as Sr. Manager of Regulatory Affairs North America at BASF Corporation, I contributed to the development of a virtual regulatory and quality portal recognized by industry peers, FDA, and USP. I decreased customs detentions by advising on regional regulatory affairs development strategy and implementation, thus smoothing the supply chain and import of products. At Tris Pharma, Inc, I played a pivotal role in reviewing submission documents, authorizing change controls, and developing departmental SOPs that guided internal and external processes. I am particularly proud of my ability to anticipate regulatory changes through intelligence mapping, which allows me to provide proactive impact assessments and transfer these insights to a global context. I invite you to connect with me to explore collaborative opportunities in regulatory affairs. Whether you\'re interested in compliance strategies, cross-functional teamwork, or simply sharing insights on the latest industry trends, I\'m always open to meaningful conversations that drive success. Let\'s connect and make an impact together!

Experience

1. Sr Regional Regulatory Affairs Manager

   BASF

   Jul 2022 — Present · US

Education

• South Gujarat University

  BS

• University at Buffalo

  BS

Skills

• Clinical Trials
• Ectd
• Clinical Development
• Pharmaceutical Industry
• Glp
• Regulatory Affairs
• Sop
• 21 Cfr Part 11
• Technology Transfer
• Fda
• Hplc
• Anda
• Gmp
• Regulatory Submissions
• Clinical Research
• Document Management
• Regulatory Requirements
• Lifesciences
• Validation
• Pharmaceutics
• Change Control
• Capa