Regulatory Affairs Specialist Job in Clinetra Solutions – Apply Now

Are you looking to grow your career in Regulatory Affairs with a strong, compliance-driven organization? Clinetra Solutions, a leader in pharma, medical devices, and MedTech regulatory compliance, is hiring a Regulatory Affairs Specialist for its Hyderabad location. This full-time, on-site role is ideal for professionals with hands-on experience in regulatory submissions, product approvals, and compliance across global markets.

This job article is crafted to help you understand the role, responsibilities, required qualifications, and the step-by-step application process.

Key Responsibilities

As a Regulatory Affairs Specialist, you will be responsible for:

• Preparing, reviewing, and submitting regulatory documents for product approvals, variations, and renewals.
• Monitoring and interpreting updates in global and local regulatory guidelines.
• Acting as the primary point of contact for regulatory agencies and notified bodies.
• Collaborating with product development, quality, clinical, and marketing teams.
• Reviewing labeling, packaging, and promotional content for compliance.
• Maintaining regulatory databases and inspection-ready documentation.
• Supporting audits, inspections, and CAPA implementation.
• Contributing to regulatory strategies for new markets, product changes, and risk management.

Required Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Engineering, or a related field.
• 2–4 years of Regulatory Affairs experience (pharma, medical devices, healthcare products).
• Experience with regulatory submissions to CDSCO / US FDA / EMA or other authorities.
• Solid understanding of global regulatory frameworks and compliance standards.
• Excellent communication skills and strong documentation capability.
• Ability to manage multiple regulatory projects simultaneously.

Benefits of Working with Clinetra Solutions

• Opportunity to work closely with industry experts in pharma & MedTech.
• Exposure to global regulatory processes and multi-region submissions.
• Growth-focused environment with real-world training support.
• Hands-on involvement in audits, compliance, and product lifecycle management.
• Competitive salary based on experience.

How to Apply

Application Link