Experience: 4+ Years
Qualification: M.Pharm (Regulatory Affairs or Quality Assurance Preferred)
Employment Type: Full-Time
Industry: Pharmaceutical Manufacturing / Regulatory Affairs

Job Overview

We are looking for an experienced Regulatory Affairs – Labelling Specialist to join our growing Regulatory Affairs team. This role focuses on managing pharmaceutical labeling activities for EU and US markets, ensuring compliance with global regulatory standards and supporting the successful submission and lifecycle management of pharmaceutical products.

The ideal candidate will have hands-on experience in formulation regulatory affairs, EU and US labeling requirements, artwork review, regulatory documentation, and lifecycle management. You will work closely with Quality Assurance, Packaging Development, and cross-functional teams to ensure labeling accuracy and regulatory compliance.

Key Responsibilities

Regulatory Labelling

• Prepare, review, and approve pharmaceutical labeling content for EU and US markets.
• Ensure labeling artwork and packaging materials comply with EMA, FDA, and country-specific regulatory requirements.
• Review labeling texts for accuracy, consistency, and regulatory compliance.
• Support submission-ready labeling documentation.

Regulatory Compliance

• Ensure compliance with EMA, FDA, and global regulatory labeling guidelines.
• Maintain current knowledge of evolving international labeling regulations.
• Support regulatory inspections and audits related to labeling activities.
• Ensure all labeling documentation meets quality and regulatory standards.

Lifecycle Management

• Manage labeling lifecycle activities including product variations, updates, and change controls.
• Coordinate implementation of approved labeling changes across products.
• Track regulatory commitments and ensure timely execution of labeling updates.
• Support ongoing product maintenance activities.

Cross-Functional Coordination

• Collaborate with Regulatory Affairs, Quality Assurance, Packaging Development, and Manufacturing teams.
• Coordinate artwork approvals and labeling implementation.
• Provide regulatory support for new product launches and post-approval changes.
• Resolve labeling-related queries from internal stakeholders and regulatory agencies.

Documentation & Regulatory Support

• Prepare and maintain accurate regulatory documentation.
• Respond to regulatory authority queries related to labeling.
• Maintain documentation in accordance with company procedures and global regulatory standards.
• Ensure proper version control and document management.

Required Qualifications

Educational Qualification

• M.Pharm in Regulatory Affairs or Quality Assurance (Preferred)
• Bachelor’s or Master’s Degree in Pharmacy or related Life Sciences discipline

Experience Required

• Minimum 4+ years of experience in Pharmaceutical Regulatory Affairs.
• Hands-on experience in pharmaceutical formulation labeling.
• Strong exposure to EU and US regulatory markets.
• Experience managing artwork review, labeling documentation, and lifecycle management.
• Knowledge of global labeling regulations and change management processes is essential.

Required Skills

• Regulatory Affairs
• Pharmaceutical Labelling
• EU Regulatory Compliance
• US FDA Labelling
• EMA Guidelines
• Artwork Review & Approval
• Regulatory Documentation
• Change Control Management
• Lifecycle Management
• Pharmaceutical Formulations
• Quality Assurance Coordination
• Cross-Functional Collaboration
• Regulatory Submissions
• Documentation Management

Key Competencies

• Strong Attention to Detail
• Regulatory Compliance Knowledge
• Analytical Thinking
• Documentation Accuracy
• Problem-Solving Skills
• Time Management
• Communication Skills
• Team Collaboration
• Quality Focus
• Regulatory Decision Making

Why Join Us?

• Work with a fast-growing pharmaceutical organization serving global markets.
• Gain exposure to EU and US regulatory submissions and labeling projects.
• Collaborate with experienced Regulatory Affairs professionals.
• Opportunity to contribute to the development of high-quality medicines for patients worldwide.
• Excellent career growth in pharmaceutical regulatory affairs.