Senior Manager Regulatory Affairs

Company Description

Maiva Pharma Private Limited, formerly known as Global Pharmatech, has been a trusted manufacturer of high-quality sterile injectables since 1996. With a strong commitment to Quality and Compliance, Maiva has built a reputation for reliability within the industry. The facility has capabilities for both aseptically filled and terminally sterilized products and is located on a 5-acre site in Hosur, Tamil Nadu. Maiva is USFDA, EU-GMP, Health Canada, and PIC/S approved, and performs end-to-end pharmaceutical development and manufacturing.

Role Description

This is a full-time on-site role for a Senior Manager of Regulatory Affairs located in Hosur. The Senior Manager will be responsible for ensuring regulatory compliance, managing regulatory requirements and submissions, and overseeing quality systems. Daily tasks include preparing and submitting regulatory documents, ensuring the facility meets all regulatory standards, and collaborating with various departments to maintain compliance.

Qualifications

• Experience in Regulatory Compliance and Regulatory Requirements
• Expertise in Regulatory Affairs and Regulatory Submissions
• Knowledge of Quality Systems
• Strong attention to detail and organizational skills
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team
• Bachelor's or Master's degree in Pharmacy, Life Sciences, or related field