Smruthi Organics Limited
Website:
smruthiorganics.com
Job details:
Company Description
Smruthi Organics Limited, a BSE-listed company, is a trusted partner to the global pharmaceutical industry with over 35 years of expertise in manufacturing high-quality Active Pharmaceutical Ingredients (APIs) and Intermediates. Recognized for leadership in Anti-Diabetic and Anti-Hypertension therapies, the company is expanding its portfolio into high-value Anti-Platelet solutions. With a strong focus on global regulatory compliance, Smruthi Organics has filed DMFs in multiple international markets and invests in digitally-driven regulatory excellence. The company operates a WHO-GMP approved facility in Solapur and has an innovative R&D center in Hyderabad supported by over 550 professionals.
Role Description
The Assistant Manager–Regulatory Affairs will oversee regulatory compliance and play a critical role in preparing and submitting regulatory dossiers. Key responsibilities include ensuring compliance with global regulatory requirements, managing quality systems, and coordinating regulatory submissions. The role contributes to maintaining and strengthening the company's global regulatory footprint. This is a full-time on-site role located @Balanagar, Hyderabad.
Qualifications
- In-depth understanding of Regulatory Compliance and Regulatory Requirements.
- Hands-on experience in Regulatory Affairs and preparing Regulatory Submissions.
- Familiarity with Quality Systems and ensuring adherence to standards.
- Strong attention to detail and understanding of international pharmaceutical regulations.
- Bachelor’s or Master’s degree in Pharmacy, Chemistry, or a related field.
- Excellent organizational and time-management skills.
- Previous experience in API manufacturing or pharmaceutical regulatory environments is a plus.
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