Regulatory Affairs Officer

Why This Role Matters
The Regulatory Affairs Officer role supports the preparation and submission of regulatory documentation required for pharmaceutical and nutraceutical products in international markets. The position ensures that products comply with global regulatory standards while supporting timely product registrations and regulatory approvals.

Job Description
The Regulatory Affairs Officer will assist in preparing regulatory dossiers, compiling product registration documents, and coordinating with internal teams to ensure regulatory compliance. The role involves supporting submissions for ROW (Rest of World) markets and maintaining regulatory documentation aligned with international guidelines.

Key Features of the Role
• Opportunity to start a career in pharmaceutical regulatory affairs
• Exposure to international regulatory submissions for ROW markets
• Hands-on experience in regulatory documentation and dossier preparation
• Collaboration with cross-functional teams including QA, QC, and production
• Career development opportunities in pharmaceutical and nutraceutical regulatory systems

Responsibilities
• Prepare and review regulatory dossiers for ROW market submissions
• Compile product registration documents and regulatory submissions
• Coordinate with QA, QC, and production departments for required documentation
• Ensure compliance with international regulatory requirements
• Track submission timelines and maintain regulatory records
• Support regulatory queries and respond to health authority questions
• Maintain regulatory documentation according to regulatory guidelines

Required Qualifications

Educational Requirements
• Bachelor of Pharmacy (B.Pharm) OR
• Master of Pharmacy (M.Pharm) OR
• Master of Science (M.Sc)

Experience and Skills
• Freshers or candidates with up to 1 year of experience in Regulatory Affairs
• Understanding of pharmaceutical documentation and regulatory processes
• Basic knowledge of global regulatory guidelines preferred
• Strong documentation and communication skills
• Ability to coordinate with cross-functional teams

Salary Insights
• Estimated Salary: INR 2.5 LPA – INR 4 LPA
• Salary may vary depending on qualifications and experience

Company Overview
Medispark Healthcare operates in the pharmaceutical and nutraceutical sector, focusing on product development, regulatory compliance, and global market expansion. The company supports international regulatory submissions and works across multiple healthcare product segments, providing opportunities for professionals to build expertise in pharmaceutical regulatory affairs.

FAQs
• What qualifications are required for this role?
Candidates must have B.Pharm, M.Pharm, or M.Sc qualifications.

• Is prior experience required?
Freshers and candidates with up to one year of experience can apply.

• What markets will the role support?
The position focuses on regulatory submissions for ROW (Rest of World) markets.

• Where is the job located?
The role is based in Ahmedabad, Gujarat, India.

Application Tips
• Highlight any regulatory affairs coursework or internship experience
• Mention knowledge of dossier preparation and regulatory documentation
• Include experience working with QA, QC, or production teams if applicable
• Emphasise communication and documentation skills
• Structure your regulatory knowledge clearly in your resume