Novartis, a global leader in innovative medicines, has announced multiple Regulatory Affairs CMC and Scientific Writing job openings in Hyderabad. These roles are ideal for professionals with experience in regulatory CMC operations, eCTD submissions, compliance, and scientific promotional writing who want to contribute to high-impact global healthcare programs.

If you are seeking Novartis jobs in Hyderabad, RA CMC submission coordinator jobs, or scientific writing pharma jobs, this opportunity is highly relevant.

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✅ Open Positions

1. RA CMC Submission Coordinator
2. RA CMC Senior Submission Coordinator
3. Senior Associate – Scientific Writing

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📌 Job Location

Hyderabad, Telangana (Office / Hybrid for Scientific Writing)

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🧪 RA CMC Submission Coordinator – Key Responsibilities

• Perform CMC submission QC and document formatting checks
• Prepare IND Annual Reports and regulatory compliance reports
• Ensure documents meet eCTD compliance standards
• Create submission folders, metadata, and RA request forms
• Coordinate CMC submissions with RA Publishing
• Maintain GMP certificates and manufacturing authorizations
• Act as data steward in RIMS/DMS

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🧬 RA CMC Senior Submission Coordinator – Key Responsibilities

• Independently manage complex CMC submission coordination
• Perform advanced QC, DA checks, and IND AR writing
• Create metadata forms, tracking sheets, and HA forms
• Act as super-user and business data owner in RIMS
• Handle CO requests and ticketing systems
• Identify compliance risks and propose mitigation strategies

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✍️ Senior Associate Scientific Writing – Key Responsibilities

• Develop compliant promotional scientific content
• Update materials based on latest label and ISI/PI changes
• Support omnichannel content planning
• Liaise with editorial, creative, and regulatory teams
• Mentor junior writers
• Maintain label update checklists

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🎓 Qualifications

RA CMC Submission Coordinator

• M.Pharm: 2+ years regulatory experience
• Other scientific master’s: 3+ years regulatory experience
• Experience with RIMS, DMS, data standards, eCTD

RA CMC Senior Submission Coordinator

• M.Pharm: 5+ years regulatory experience
• Other scientific master’s: 6+ years regulatory experience

Senior Associate Scientific Writing

• Advanced degree in Life Sciences / Pharmacy / Medicine
• 3–5 years experience in scientific/promotional writing

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💼 Skills Required

• Regulatory CMC Operations
• eCTD Submissions
• Documentation Management
• Data & Digital Fluency
• Scientific Writing
• Promotional Compliance
• Omnichannel Marketing

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🎁 Benefits at Novartis

• Competitive salary & performance bonus
• Hybrid/office work model
• Global exposure and career growth
• Learning & development programs
• Inclusive and diverse work environment

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📝 How to Apply

Application Link For RA CMC Submission Coordinator

Application Link For RA CMC Senior Submission Coordinator

Application Link For Senior Associate Scientific Writing