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RA CMC Submission Coordinator

2 - 11 years

8 - 9 Lacs

Hyderabad

Posted:2 weeks ago| Platform: Naukri logo

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Skills Required

Publishing PDF Operational excellence Data management Pharmacy CMC Data processing Biochemistry GMP Information management

Work Mode

Work from Office

Job Type

Full Time

Job Description

Summary Provide regulatory CMC operational, submission and compliance support to department in accordance to defined requirements to guarantee timely preparation of high-quality CMC regulatory submissions and associated compliance information throughout the life cycle. About the Role Major accountabilities: Perform compliance and operational activities including QC check, DA 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 forms, RA request forms and act as data stewards in the applicable Regulatory Information 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 Operations Perform super-user role of RA CMC documentation system/ support super-user for e. g. account requests/ modifications as assigned Acquire and maintain GMP Certificates and Manufacturing Authorizations required for RA CMC submission in the Document Management System Support other GSOC team members for end-to-end submission coordination Key performance indicators: High quality regulatory submissions and operational documentation Timeliness of deliverables: No delays in approvals of clinical studies, global registration dossiers or variations due to late or inadequate CMC documentation and compliance support on matters within RA CMC control Timely and accurate information / communication about operational and compliance issues within own department and to key stakeholders Ensure that the operational activities and CMC regulatory documentation follow Novartis and eCTD guidelines. Regulatory compliance met in all compliance systems Build and maintain collaborative partnerships with stakeholder Partner with other GSOC team members to ensure business continuity Minimum Requirements: Work Experience: If University entrance or completed vocational training: Preferably 2 years in regulatory and/or experience in the pharmaceutical industry If Science Degree: Preferably 1 year in regulatory and/or experience in the pharmaceutical industry Working experience in pharma industry data systems and data management Ability to work successfully with global project teams and prioritize activities considering timelines and workload Effective planning, organizational and interpersonal skills Prior publishing experience desired Computer literacy/IT systems literacy: Excellent data processing skills Skills: Being Resilient Digital & Technology Savvy Continuous Learning Interpersonal Savvy Operational Excellence Project Excellence Education: Minimum: General qualification for university entrance or completed vocational training Desirable: Science Degree (e. g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent Languages: Fluent English required (oral and written). Good written/spoken communication skills 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 Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork. novartis. com/network Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:

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Pharmaceutical Manufacturing

Basel Baselstadt

10001 Employees

433 Jobs

    Key People

  • Vas Narasimhan

    CEO

  • Marie-France Tschudin

    President, Innovative Medicines

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