Manager- Drug Regulatory Affairs

2 weeks ago

Ahmedabad, Gujarat, India Lezivia Lifesciences Full time ₹ 15,00,000 - ₹ 25,00,000 per year

Company Description

Lezivia Lifesciences is a reputed company known for its quality pharmaceutical products. Most of our products are manufactured at WHO-approved facilities, ensuring the highest quality standards for patient care. We are dedicated to delivering the best products to improve patient outcomes and well-being.

Role Description

This is a full-time, on-site role located in Ahmedabad for a Manager of Drug Regulatory Affairs specializing in Pharma Oral Solid Dosage (OSD) forms. The role involves managing regulatory compliance, preparing and submitting regulatory documents, and ensuring adherence to regulatory requirements. The Manager will work closely with quality assurance teams to maintain the quality systems and will be responsible for keeping up-to-date with changes in regulatory affairs to ensure ongoing compliance.

Qualifications

  • Strong understanding of Regulatory Compliance, Regulatory Requirements, and Regulatory Affairs
  • Experience in Regulatory Submissions
  • Knowledge of Quality Systems
  • Excellent analytical and organizational skills
  • Bachelor's degree in Pharmacy, Chemistry, Biology, or a related field
  • Prior experience in the pharmaceutical industry, particularly with Oral Solid Dosage forms, is preferred
  • Ability to work on-site in Ahmedabad
  • Strong communication and interpersonal skills

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