Job Title:
Assistant Manager - Regulatory Affairs
Job Location:
India
Company:
Novartis
Job ID:
REQ-10048070
Posted Date:
April 09, 2025
Role Overview:
The Assistant Manager will oversee the regulatory affairs documentation system, ensuring compliance with regulatory requirements. This includes managing new drug applications, line extensions, clinical trial applications (CTA), and post-approval activities. The role requires working with cross-functional teams, handling regulatory intelligence, and ensuring compliance with local and international regulations.
Key Responsibilities:
Compilation and submission of New Drug applications, clinical trial applications (CTA), site registrations, and production transfer applications.
Develop and implement regulatory strategies for pipeline products and clinical trial projects.
Maintain compliance with regulations such as PSURs, post-approval changes, and clinical trial material clearances.
Cross-functional coordination with Legal, Public Affairs, and other departments for regulatory submissions.
Provide training and guidance on regulatory requirements to internal teams.
Assist with regulatory intelligence and managing regulatory submissions.
People management responsibilities including guiding and mentoring Regulatory Affairs Executives.
Key Performance Indicators:
Timely submission and approval of regulatory applications and follow-up information.
Timely management of clinical trial approvals and renewals.
Innovation in handling regulatory challenges and ensuring adherence to submission timelines.
Regular updates on policy and regulatory changes.
Qualifications & Experience:
Minimum Education: Degree in Pharmacy, Health Discipline, or Life Sciences.
Desirable: Post-graduate degree in Pharmacy, Health Discipline, or Life Sciences.
Experience: 6-7 years in regulatory affairs in India, with experience in Indian and multinational companies.
Skills: Documentation management, regulatory compliance, project management, and operational excellence.
Why Novartis:
Novartis is committed to improving patient outcomes and creating a community of passionate people to achieve breakthroughs in healthcare. Join Novartis to help shape the future of medicine.
Benefits and Rewards:
Explore Novartis' benefits to thrive personally and professionally. For more details, visit Novartis Benefits & Rewards.
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