Position: Global CMC Regulatory Lead
Location: Hyderabad, India
About the Role:
We are seeking a Global CMC Regulatory Lead to independently provide strategic and operational regulatory direction for projects/products across development, registration, approval, and post-approval activities. The role requires balancing patient and business risks to make informed regulatory decisions, ensuring timely Health Authority approvals.
Key Accountabilities:
Formulate and drive global CMC regulatory strategy with an emphasis on innovation, compliance, and maximizing business benefits. Lead and implement global CMC submission activities, including planning, authoring, reviewing, coordination, and submission for assigned projects/products. Identify required documentation, manage quality and timeline issues for global submissions, and negotiate the timely delivery of approved technical documents. Author and/or review high-quality CMC documentation for Health Authority submissions, ensuring technical congruency, regulatory compliance, and adherence to e-publishing requirements. Proactively communicate CMC regulatory strategies, risks, and key issues throughout the lifecycle of projects, and represent the department in cross-functional project teams. Lead Health Authority interactions, negotiations, and prepare briefing books, risk mitigation plans, and rehearsals. Also, represent the department in due diligence teams for in-licensing and divestment opportunities.
Key Performance Indicators:
Produce high-quality project documentation, ensuring no delays or late changes due to inadequate evaluation. Timely delivery of regulatory submissions, including clinical studies, global registration dossiers, and variations. Maintain accurate, reliable communication with key stakeholders and provide high-quality regulatory advice and strategic input. Ensure CMC regulatory documentation follows Novartis and regulatory guidelines. Build collaborative partnerships and successfully manage cross-functional teams and projects.
Education and Experience:
Minimum: Science Degree (Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent.
Desirable: Advanced Science Degree.
Languages: Fluent in English (oral and written), with excellent communication skills.
Experience: Minimum 5 years in regulatory, preferably in the pharmaceutical industry. Experience in regulatory submission and approval processes, and knowledge of chemistry/biotechnology or pharmaceutical technology is essential. A demonstrated track record in interdisciplinary global team leadership, planning, and prioritizing multiple projects. Ability to work independently, manage global teams, and prioritize tasks efficiently.
Novartis is committed to building an inclusive work environment and diverse teams that reflect the communities we serve. We provide reasonable accommodations for individuals with disabilities during the recruitment process. If you need assistance, please contact us at diversityandincl.india@novartis.com.
Why Novartis:
At Novartis, our mission is to reimagine medicine to improve and extend people's lives. Join our team of passionate individuals committed to making a difference. Learn more about our people and culture at Novartis Strategy.
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Benefits and Rewards:
Discover how we support your personal and professional growth in our Benefits Handbook.
Division: Development
Business Unit: Innovative Medicines
Location: Hyderabad, India
Company / Legal Entity: Novartis Healthcare Private Limited
Functional Area: Research & Development
Employment Type: Full-time, Regular
Shift Work: No
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