Povzetek
About the Role
About the role
Help deliver accurate, compliant, on-time CMC submissions that keep studies moving and products available for patients. This role is ideal for a detail-driven professional who values structured processes and wants to build depth in CMC submission coordination, centralization of regulatory activities, and in data and digital tools.
Key Responsibilities:
- Perform compliance and operational activities including CMC submission QC check, Document Format checks and IND annual report writing. CMC contact for some countries and compliance/ regulatory database entry and reports
- Create CMC submission documentation such as folders structure, metadata, RA request forms and act as data stewards in the applicable Regulatory Information and Documentation Management System
- Ensure CMC documentation is eCTD compliant, eCTD filenames assigned, Document formatting (DA) checked, PDF properties are compliant for eCTD submission, documentation is finalized and eCTD file names assigned
- Coordinate data/KPIs required for reports within RA CMC
- Support project teams for document finalization, collate ancillary documents requirements from various sources (e.g. databases, OneNote, trending etc.) and support coordination and management through the appropriate system
- Coordinate, prepare and track CMC submissions for delivery to RA Publishing
- Perform super-user role of RA CMC documentation system/ support super-user for e.g. account requests/ ticket generation/ modifications as assigned
- Acquire and maintain GMP Certificates and Manufacturing Authorizations required for RA CMC submission in the Document Management System
- Support other team members for end-to-end submission coordination
Essential Requirements
- For Master’s in Pharmacy: Minimum 2 years of regulatory experience in Regulatory CMC operations, compliance, and project management. Internship experience during the degree program is not counted.
- For Other Scientific Master’s Degrees: Minimum 3 years of regulatory experience in Regulatory CMC operations, compliance, and project management. Internship experience during the degree program is not counted.
- Experience with: Pharmaceutical industry documentation systems, Regulatory Information Management Systems (RIMS), Data standards, data systems and data management tools
- Proven ability to work effectively with global, cross functional project teams
- Strong planning, organizational, and interpersonal skills
- Demonstrated ability to manage multiple priorities simultaneously (multitasking is essential)
- High level of computer literacy and competency with data driven and IT systems; strong data processing skills
- High level of digital and data fluency including familiarity with AI‑enabled tools and emerging IT technologies.
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
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Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
