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- Maintain and upload data to Health Authority databases, including SUGAM and FDA
- Compile and submit applications for product registration, such as drugs, medical devices, and food supplements
- Handle CMC queries and lifecycle management, including labeling, license renewals, and artwork reviews
- Develop and implement regulatory strategies for export markets and ensure compliance with CDSCO and international regulations
- Support inspections, audits, and internal Quality Management Systems (QMS)
- Manage product complaints, recalls, and suspected falsified products
- Maintain global and local regulatory databases
- B.Pharm/M.Sc. degree with 7+ years of experience; MBBS/M.Pharm/Ph.D. preferred
- Strong understanding of CMC, non-clinical, and clinical data; proficiency in MS Office; excellent communication and organizational skills
- Knowledge of regulatory requirements, drug development, risk-benefit analysis, adaptability, and teaching ability
- Professional discretion, ability to work independently, attention to detail, and enthusiasm for maintaining high standards in regulatory and pharmacovigilance activities
Assistant Manager- Regulatory Affairs - Mumbai - Domnic Lewis Private Limited

1 month ago

Description
Job Description: We are seeking an Assistant Manager- Regulatory Affairs and Pharmacovigilance to support a Global Pharmaceutical MNC based in Mumbai.
Position: Assistant Manager- Regulatory Affairs (Domestic Market)
Key Responsibilities:
Requirements:
Key Attributes:
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Lead- Regulatory Affairs
Permanent Michael Page- Mumbai
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Regulatory Affairs Executive
Full time Ipca Laboratories Limited- Mumbai
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Regulatory Affairs- Executive
Unichem Laboratories Limited- Mumbai
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Regulatory Affairs Specialist
Permanent Michael Page- Mumbai
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Senior Manager-Regulatory Affairs
Genpact- Mumbai
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Quality Assurance and Regulatory Affairs
IF MedTech Pvt Ltd- Navi Mumbai
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Executive / Senior Executive/ Assistant Manager - Regulatory Affairs US Market
Unichem Laboratories Limited- Mumbai
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Manager Medical Affairs – Neuroscience
Amneal Pharmaceuticals- Mumbai
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Customer service specialist
Asahi Kasei- Mumbai
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Regional Manager
Allied Blenders & Distillers Ltd.- Mumbai
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r - RA (Formulation)
BEST-FIT Recruitment Riders- Mumbai
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Company Secretary
APTO SOLUTIONS - EXECUTIVE SEARCH & CONSULTANTS- Mumbai
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Company Secretary
Antal International- Mumbai
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Regional Medical Advisor
Right Advisors Private Limited- mumbai
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Medical Advisor
Abbott Laboratories- Mumbai
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Export Manager
Maximaa Systems Ltd- Mumbai
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Liaison Officer
Acme Services- Mumbai
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Senior Medical Advisor
Abbott Laboratories- Mumbai
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Compliance Officer
Nuvama Group- Mumbai
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Operational Compliance Specialist
Imaging Endpoints- Mumbai