AstraZeneca Hiring for Regulatory Affairs Manager @Bangalore-apply now
About Company
AstraZeneca is a global, science-led biopharmaceutical company dedicated to discovering, developing, and commercializing prescription medicines for some of the world’s most serious diseases. We prioritize patients and science to make a difference in people’s lives.
Position Name :Regulatory Affairs Manager
Organization :AstraZeneca
Qualification:M.Pharm/ B.Pharm
Experience:6-10 years
Salary:N/A
Location:Bangalore
Regulatory Affairs Manager
Location: Bangalore, India
Type: Full-time
Posted On: 12-Jul-2024
Job Requisition ID: R-198718
Application Deadline: 11-Aug-2024
Position Purpose:
As a Regulatory Affairs Manager, you will develop India-specific artwork, support regulatory dossier preparation and submissions (e.g., new drug applications, site registration, clinical trials, import licenses), and manage registration samples from dispatch to report. You will also oversee license life cycle management and ensure adequate representation in SEC.
Key Responsibilities:
- Adherence to Conduct Codes: Align with AstraZeneca’s values, vision, and codes of conduct. Ensure compliance with local legislation, global regulatory policies, and corporate governance.
- Licensing Management: Monitor product license status, manage changes, maintain documentation records, and communicate updates promptly.
- Regulatory Plans: Develop and implement regulatory plans for product approvals and launches. Maintain detailed knowledge of product aspects, ensure local strategies align with global priorities, and track status for prompt approvals.
- Team Leadership: Provide direction within project teams, ensure high performance, build team commitment, and foster an open, trusting atmosphere.
- Issue Management: Provide detailed regulatory status information and undertake follow-up actions as necessary.
- Regulatory Environment Awareness: Interact with regulatory authorities, monitor external changes impacting products, communicate impacts to stakeholders, and influence regulatory outcomes.
- Competitive Intelligence: Monitor global pharmaceutical pipelines, analyze information, and provide risk-benefit analysis for AstraZeneca.
Internal Customers:
Marketing, Sales, Logistics, Medical, Legal Affairs, Intellectual Property, Global Product Teams, Key Brand Teams, International Regulatory Affairs, Manufacturing Sites, QA, Regional Office
External Customers:
CDSCO Office, NIB, IPC, CDTL, CDL, NCB & DCK, Local Health Authorities, Government Agencies, Manufacturers, Local Trade Associations, Legal Professionals
Minimum Requirements:
- Qualifications: M.Pharm/B.Pharm
- Experience: 6-10 years in India Regulatory function with knowledge of dossier compilation and Indian regulations
Why AstraZeneca?
At AstraZeneca, we are committed to being a Great Place to Work. We empower you to push the boundaries of science and unleash your entrepreneurial spirit. Join us to make a difference in medicine, patients, and society. We offer an inclusive culture that champions diversity, collaboration, lifelong learning, and growth.
Find Out More:
Diversity and Inclusion:
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds and perspectives. We comply with all applicable laws on non-discrimination in employment and recruitment.
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