Job Description

390425BR

RA CMC Senior Submission Coordinator

India
About the role
Your responsibilities include, but are not limited to:

• Manages medium to small level global regulatory submission projects. Provide submission and contribute to the technical related regulatory strategy, intelligence and knowledge required to develop, register, and maintain global products. Contribute to strategic and technical input /support to drive implementation of global systems, tools and processes to support global development projects and/or marketed products. Frequent internal company and external contacts. Represents organization on specific projects

• Works on problems of moderate scope where analysis of situations or data requires a review

of a variety of factors. Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt. Distribution of marketing samples (where applicable)

• Independently, perform RA CMC compliance and operational support including QC check, DA checks, IND AR writing & coordination. CMC contact for some countries, compliance/regulatory database entry and reports and ensure appropriate eCTD operator attributes, module chapters. Create CMC submission documentation such as folders structure, metadata forms, RA request forms, populating RA CMC tracking sheets, letters, and various Health Authority forms. Act as super-user, business data owner and data steward in the applicable Regulatory Information Management System
• Proactively ensure CMC documentation is eCTD compliant and submission ready. Support eCTD compliance maintenance for the external documentation linked to the CMC submission modules, including third party documentation. Independently support CMC project teams for document finalization, ancillary documents coordination and source documents management. Coordinate, prepare, compile and track CMC submissions for delivery to RA Operations
• Support RA CMC project teams to handle Country Organization (CO) request in the RA CMC ticketing system, organizing submission coordination activities like source documents and ancillary documents collection
• Perform super-user role of documentation system / support super-user for e.g. account requests / modifications as assigned
• Actively participate as a member of the global RA CMC project teams by contributing to the project operational and compliance strategy, identifying the potential compliance issues and sharing lessons learned
• Acquire and maintain GMP Certificates and Manufacturing Authorizations required for RA CMC submission in the Document Management System. Coordinate preparation of declarations required for submission in RoW countries. Support other GSOC team members in leading various operations, compliance, Data & Digital initiatives

Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements

• Fluent English (oral and written)
• If University entrance or completed vocational training: Preferably 3 years in regulatory and/or experience in the pharmaceutical industry.
• If Science Degree: Preferably 2 years 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 with current operating systems
  

WHY NOVARTIS

769 million lives were touched by Novartis medicines in 2020, and while we\xe2\x80\x99re proud of this, we know there is so much more we could do to help improve and extend people\xe2\x80\x99s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what\'s possible, when we collaborate with courage to aggressively and ambitiously tackle the world\xe2\x80\x99s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team\xe2\x80\x99s representative of the patients and communities we serve.
Join our Novartis Network : If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Division
Development
Business Unit
REG AFFAIRS GDD
Work Location
Hyderabad, AP
Company/Legal Entity
Nov Hltcr Shared Services Ind
Functional Area
Research & Development
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
No