Sr. Director, Regulatory Affairs

Job Summary:
The Director, Regulatory Affairs – India Operations will lead the India-based regulatory function, with primary responsibility for managing and executing high-quality regulatory submissions for the U.S. market, with a focus on complex sterile generic products including peptides, microspheres, and drug-device combinations. This role is central to ensuring timely ANDA submissions, comprehensive and effective responses to complex FDA deficiencies, and seamless coordination with global stakeholders and strategic partners. The position requires deep expertise in U.S. regulatory requirements, strong leadership skills to manage and grow a high-performing team, and the ability to operate in a dynamic, cross-functional, and international environment.
Key Responsibilities:
1.
Regulatory Strategy & Execution:
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Lead the planning, preparation, and submission of high-quality ANDAs for the U.S. FDA, focusing on sterile and complex dosage forms.
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Ensure submission strategy and dossier content align with FDA expectations and current regulatory standards.
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Drive timely, accurate, and strategic responses to complex deficiency letters, including scientific justifications, bridging strategies, and risk-based assessments.
2.
Complex Dosage Expertise:
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Serve as the regulatory subject matter expert for complex dosage forms including peptides, microspheres, injectable suspensions, and drug-device combination products.
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Anticipate regulatory challenges and proactively mitigate potential issues during development and review phases.
3.
Team Leadership & Talent Development:
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Lead and mentor a growing team of 15+ Regulatory Affairs professionals, fostering a culture of accountability, innovation, and continuous improvement.
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Implement effective training, knowledge sharing, and performance development programs to strengthen technical and regulatory capabilities within the team.
4.
Cross-Functional & Partner Collaboration:
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Collaborate closely with R&D, QA, CMC, CMO, Project Management, and global Regulatory Affairs teams to drive regulatory activities and timelines.
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Serve as the key regulatory contact for external development and commercial partners, ensuring alignment and responsiveness in joint submissions and communications.
5.
Regulatory Intelligence & Compliance:
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Monitor and interpret U.S. FDA regulatory developments and trends; ensure dissemination of critical updates to internal stakeholders.
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Maintain high standards of regulatory compliance and documentation integrity throughout the submission lifecycle.
6.
Planning & Communication:
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Develop and manage regulatory project plans, submission timelines, and team deliverables, ensuring visibility and alignment with global leadership.
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Provide regular status updates, risk assessments, and strategic insights to senior management on ongoing submissions and regulatory priorities.
Qualifications & Experience:
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Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related discipline.
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15+ years of experience in Regulatory Affairs within the generic pharmaceutical industry, with deep expertise in U.S. FDA ANDA submissions.
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Demonstrated success in handling complex products and preparing strategic responses to FDA deficiency letters.
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Strong knowledge of eCTD submissions, FDA regulatory pathways, and current GDUFA environment.
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Proven experience managing and growing regulatory teams of 15+ professionals.
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Effective communicator with ability to influence across functional lines and international stakeholders.
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Experience working with external development, CMO, and licensing partners is essential.
Preferred Skills:
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Exposure to global regulatory filings (EU or RoW) is an advantage but not required.
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Familiarity with regulatory publishing tools and document tracking systems.
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Ability to thrive in a matrixed, deadline-driven, and fast-paced work environment.

Qualifications & Experience:
•
Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related discipline.
•
15+ years of experience in Regulatory Affairs within the generic pharmaceutical industry, with deep expertise in U.S. FDA ANDA submissions.
•
Demonstrated success in handling complex products and preparing strategic responses to FDA deficiency letters.
•
Strong knowledge of eCTD submissions, FDA regulatory pathways, and current GDUFA environment.
•
Proven experience managing and growing regulatory teams of 15+ professionals.
•
Effective communicator with ability to influence across functional lines and international stakeholders.
•
Experience working with external development, CMO, and licensing partners is essential.