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Are you a regulatory professional passionate about compliance, clinical trial submissions, and pharma innovation? Novartis is seeking a motivated Executive/Assistant Manager – Regulatory Affairs to join its Mumbai office. This role offers the chance to work with global teams, ensure regulatory compliance, and contribute to life-saving medicines.
If you are looking for pharmaceutical regulatory affairs jobs in India, this opening could be the right step in your career growth.
Key Responsibilities
As Executive/Assistant Manager – Regulatory Affairs at Novartis, you will:
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- Compile and submit Health Authority (HA) applications including new drugs, line extensions, site registrations, renewals, and production transfers.
- Prepare and submit Clinical Trial Applications (CTA) dossiers for GDO projects.
- Develop and implement regulatory strategies to expedite product launches in India.
- Handle critical applications like legal entity name changes, agent transfers, and warehouse relocations.
- Maintain regulatory compliance activities such as PSUR, CMC changes, and pack insert updates.
- Oversee regulatory requirements for ongoing clinical trial projects from submission to study completion.
- Collaborate cross-functionally with Legal, Public Affairs, Supply Chain, and QA teams.
- Track regulatory updates, support inspections, and manage CAPAs for compliance.
- Guide and mentor junior RA executives to build organizational capability.
Minimum Qualifications
- Bachelor’s degree in Pharmacy, Life Sciences, or Health Discipline (mandatory).
- Postgraduate qualification in the same field (preferred).
- 3–5 years of experience in Regulatory Affairs within multinational pharma companies.
- Strong knowledge of Indian regulatory guidelines and HA submissions.
- Cross-functional experience with HQ/overseas teams.
- Excellent communication, documentation, and IT skills (MS Word, Excel, PowerPoint, Outlook).
- Fluency in written and spoken English.
Why Join Novartis?
- Contribute to a global mission: reimagining medicine to improve and extend lives.
- Collaborate with diverse teams across India and international offices.
- Opportunity for career growth in regulatory strategy, compliance, and clinical research.
- Access to a wide range of benefits and rewards (as per Novartis Life Handbook).
- Inclusive workplace that values diversity, equity, and inclusion.
How to Apply
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