Regulatory Affairs and Pharmacovigilance Professional
2 days ago
We are seeking an experienced Regulatory Affairs and Pharmacovigilance professional to join our team at Domnic Lewis International in Mumbai, India.
About the RoleThe successful candidate will be responsible for ensuring the highest professional standards in Regulatory Affairs and Pharmacovigilance to align with business objectives, values, and regulatory compliance.
Main Responsibilities- Maintain and upload data to Health Authority databases such as SUGAM and FDA.
- Compile and submit applications for product registration including 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.
- Manage product complaints, recalls, and suspected falsified products.
We are looking for a highly skilled and experienced professional with a strong understanding of CMC, non-clinical, and clinical data. The ideal candidate will have a B.Pharm/M.Sc. degree with 7-8 years of experience or MBBS/M.Pharm/Ph.D. (preferred). Strong communication and organizational skills are essential.
Requirements- Qualifications: B.Pharm/M.Sc. with 7–8 years of experience; MBBS/M.Pharm/Ph.D. (preferred).
- Skills: Strong understanding of CMC, non-clinical, and clinical data; proficiency in MS Office; excellent communication and organizational skills.
The estimated salary for this role is ₹15,00,000 - ₹20,00,000 per annum, depending on experience. Additionally, we offer a comprehensive benefits package, including health insurance, retirement plan, and paid time off.
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