Omkar Bhandare
Regulatory Affairs Manager @ AstraZeneca India | Regulatory Compliance & Submissions
- Role
- Regulatory Affairs Senior Executive at Sandoz
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Omkar Bhandare
Regulatory Affairs professional with over 11 years of experience in pharmaceutical…
Experience
Regulatory Affairs Senior Executive
Dec 2022 — Present · Mumbai, IN
Managed regulatory evaluation and submission processes, ensuring compliance and timely approvals- Regulatory Compliance & Submissions: Ensure timely, high-quality regulatory filings, including variations, renewals, new registrations, and annual reports- Stakeholder Collaboration: Act as the Single Point of Contact (SPOC) for MRC-IN, engaging in meetings, consultations, and cross-functional initiatives- Process & Strategy Development: Define regulatory strategies, establish standard procedures, and oversee change control evaluations- Training & Performance Management: Track departmental budgets, facilitate training, certification, and performance reviews- Inspection & Audit Support: Provide assistance during health authority inspections and internal audits- Documentation & Database Management: Maintain up-to-date regulatory records, oversee submission documents, and manage samples and standards- Launch Execution & Global Coordination: Ensure timely product launches, prevent regulatory-related delays, and support global/local initiatives.
Education
BITS Pilani Work Integrated Learning Programmes
M.Tech, Pharmaceutical Operations and Management
INDIAN EDUCATION SOCIETY
High School
Saraswathi vidya bhavans college of pharmacy
Bachelor's Degree, Pharmacy
2009 — 2013
Skills
- Biotechnology
- Powerpoint
- Microsoft Excel
- Pharmaceutical Industry
- Pharmaceutics
- Microsoft Office
- Life Sciences
- Clinical Trials
- Regulatory Affairs
- Microsoft Word
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.