Associate - IRA - Export Labelling Executive

Himalaya Wellness Company; Bengaluru; On-site; INR 600,000 - 800,000; Full time

Job summary

Himalaya Wellness Company in Bengaluru is seeking a Regulatory Affairs Specialist focused on export labelling compliance. The role involves preparing and reviewing artwork, ensuring adherence to country-specific regulations, and coordinating with various teams.

The ideal candidate holds a Master’s degree in a relevant field and has experience in regulatory affairs, demonstrating strong communication and attention to detail. This position is crucial for ensuring product compliance across multiple markets.

Qualifications

• 2 years of experience in Regulatory Affairs, Artwork Management, or Export Labelling.
• Experience with global markets such as EU, UK, GCC, ASEAN, LATAM, Africa, Australia, or North America preferred.

Responsibilities

• Review and interpret country-specific labelling regulations for export markets.
• Ensure product labels comply with applicable regulatory requirements.
• Coordinate with cross-functional teams for artwork approval and change control.

Skills

Strong understanding of global regulatory labelling requirements

Knowledge of pharmaceutical packaging components

Proficiency in Microsoft Office and artwork management tools

Excellent attention to detail

Strong communication skills

Education

Master's in pharmacy, Life Sciences, Biotechnology, Chemistry

Job description

Job Summary

Responsible for the preparation, review, coordination, and maintenance of export market labelling and packaging artwork to ensure compliance with country-specific regulatory requirements, company standards, and product registration commitments.

Key Responsibilities

Regulatory Compliance

Review and interpret country-specific labelling regulations for export markets.

Ensure product labels, cartons, leaflets, and packaging components comply with applicable regulatory requirements.

Monitor changes in global labelling regulations and assess impact on marketed products.

Prepare labelling specifications and artwork briefs.

Artwork Coordination

• Coordinate with Regulatory Affairs, Packaging Development, Marketing, Supply Chain, Manufacturing, and Quality teams.
• Review artwork proofs and ensure accurate implementation of approved labelling content.
• Support artwork approval workflows and change control processes.

Change Management

• Assess labelling changes resulting from regulatory updates, product variations, safety updates, and business requirements.
• Initiate and track change controls related to labelling updates.
• Ensure timely implementation of approved changes.

Documentation & Compliance

• Maintain labelling records, approval history, and supporting documentation.
• Ensure labelling documents are audit-ready and comply with internal quality systems.
• Support internal, customer, and regulatory inspections related to labelling activities.

Stakeholder Communication

• Liaise with global affiliates, distributors, and regulatory teams regarding labelling requirements.
• Provide labelling guidance and support to cross-functional teams.

Qualifications

• Master’s in pharmacy, Life Sciences, Biotechnology, Chemistry, or related field.
• 2 years of experience in Regulatory Affairs, Artwork Management, or Export Labelling.
• Experience with global markets such as EU, UK, GCC, ASEAN, LATAM, Africa, Australia, or North America preferred.

Skills Required

• Strong understanding of global regulatory labelling requirements.
• Knowledge of pharmaceutical packaging components and artwork lifecycle management.
• Familiarity with change control and document management systems.
• Excellent attention to detail and proofreading skills.
• Strong communication and stakeholder management abilities.
• Proficiency in Microsoft Office and artwork management tools.

Preferred Knowledge

• EU Labelling Requirements
• GCC Labelling Guidelines
• ASEAN Labelling Requirements
• US FDA Labelling Requirements
• Artwork Management Systems (AWMS)
• Packaging
• Change Control and Quality Management Systems

Key Performance Indicators (KPIs)

• On-time artwork approval and implementation.
• Compliance with country-specific labelling regulations.
• Reduction in labelling errors and artwork deviations.
• Timely closure of labelling change controls.