Job Description

200+ projects in development. 20 major approvals. Novartis is looking for dedicated individuals to join our Global Regulatory Affairs team and contribute to developing our superlative pipeline of drugs and biologics into innovative therapies for our patients worldwide.

Your responsibilities include but not are limited to:

• Perform compliance and operational support including QC and DA checks, CMC

contact for some countries and compliance/ regulatory database entry and reports

• Create submission documentation such as folders, metadata forms, RA request forms

• Ensure documentation is eCTD compliant, Document formatting (DA) checked,finalized and eCTD filenames assigned.

• Coordinate data/KPIs required for reports within RA CMC

• Coordinate, prepare and track CMC submissions for delivery to RA Operations

• Perform super-user role of 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.

Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Minimum requirements
What You’ll bring to the role:

• Effective planning, organizational and interpersonal skills.
• Minimum 1+ years in regulatory and/or experience in the pharmaceutical industry.
• Prior publishing experience desired
• Computer literacy/IT systems literacy: Excellent data processing skills.
• Science Degree (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent.
• Fluent English required (oral and written). Good written/spoken communication skills.

Why consider Novartis?

769 million lives were touched by Novartis medicines in 2020, and while we’re
proud of this, we know there is so much more we could do to help improve and
extend people’s 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’s
toughest medical challenges. Because the greatest risk in life, is the risk of never
trying!

Imagine what you could do at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Division
Global Drug Development
Business Unit
REG AFFAIRS GDD
Country
India
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