Regulatory Affairs Associate

Experience: Freshers Welcomed

Location: On-Site, SG Highway, Ahmedabad

Company Description

A Square Remedies Pvt. Ltd. is a forward-thinking pharmaceutical company with expertise in launching multinational companies into highly regulated markets. Headquartered in Ahmedabad, Hong Kong, and Moscow, the company operates across the CIS region and beyond, focusing on improving human health in areas like oncology, cardiac/diabetic care, skincare, and wellness. Offering a wide range of dosage forms such as injectables, tablets, capsules, and oral liquids, A Square Remedies boasts a portfolio of over 1,500 products and 100+ product registrations worldwide.

Role Description

This is a full-time, on-site role for a Regulatory Affairs Associate based in Ahmedabad. The primary responsibilities include preparing regulatory documentation, ensuring compliance with all regulatory requirements, managing submissions, and supporting cross-functional teams to achieve timely product approvals. The role also involves collaborating with internal teams to ensure full adherence to local and global regulatory standards, maintaining up-to-date knowledge of regulatory guidelines, and liaising with regulatory authorities as needed.

Qualifications

• Strong knowledge and experience in Regulatory Documentation and Regulatory Submissions
• Thorough understanding of Regulatory Compliance and Regulatory Requirements
• Proven expertise in Regulatory Affairs with attention to detail and accuracy
• Exceptional organizational and problem-solving skills
• Ability to work independently and collaboratively with cross-functional teams
• Excellent written and verbal communication skills
• Relevant certifications or academic background in Pharmacy, Life Sciences, or related fields
• Experience in the pharmaceutical or healthcare industry is highly desirable