Regulatory Affairs Specialist
4 days ago
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Domnic Lewis, a global pharmaceutical company based in Mumbai. As an Assistant Manager- Regulatory Affairs and Pharmacovigilance, you will play a critical role in ensuring the highest professional standards in regulatory affairs and pharmacovigilance align with business objectives, values, and regulatory compliance.
Key Responsibilities:- Maintain and upload data to Health Authority databases (e.g., SUGAM, FDA)
- Compile and submit applications for product registration (drugs, medical devices, food supplements)
- Handle CMC (Chemistry, Manufacturing, and Controls) 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
The ideal candidate will possess a strong understanding of CMC, non-clinical, and clinical data, as well as proficiency in MS Office. They will also have excellent communication and organizational skills, and be proficient in MS Office.
Our company offers a dynamic work environment and opportunities for growth and development. If you are a motivated and experienced professional looking to make a difference in the pharmaceutical industry, please submit your application.
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