The organization is seeking an experienced Global Regulatory Affairs Specialist to support regulatory submissions, product registrations, lifecycle management, and compliance activities across international markets. The role will be responsible for coordinating regulatory strategies and ensuring pharmaceutical products meet applicable regulatory requirements for successful approvals and continued market access.

The position will support the preparation, review, compilation, and submission of regulatory dossiers, applications, variations, renewals, and post-approval documentation in accordance with country-specific regulatory requirements. The candidate will work closely with internal stakeholders to ensure submissions are accurate, complete, compliant, and delivered within established timelines.

The Global Regulatory Affairs Specialist will collaborate with R&D, Quality Assurance, Quality Control, Clinical, Medical Affairs, Manufacturing, Supply Chain, and Commercial teams to gather technical information and coordinate regulatory activities throughout the product lifecycle. The role will also support responses to regulatory authority queries and ensure timely implementation of regulatory commitments.

Key Accountabilities

Regulatory Submissions & Registrations

• Prepare, review, compile, and submit regulatory dossiers for new product registrations, renewals, variations, amendments, and post-approval changes.
• Manage regulatory submissions across global markets including the United States, Europe, Canada, Australia, Latin America, Middle East, Africa, ASEAN, and other international regions.
• Ensure submissions comply with applicable country-specific regulations and regulatory guidelines.

Product Lifecycle Management

• Support regulatory maintenance activities throughout the product lifecycle.
• Manage regulatory variations, renewals, artwork approvals, and change control documentation.
• Track submission timelines and approval milestones to ensure regulatory compliance.

Regulatory Intelligence

• Monitor evolving global regulatory requirements and industry developments.
• Assess the impact of regulatory changes on existing and pipeline products.
• Provide regulatory guidance and recommendations to internal stakeholders.

Cross-Functional Collaboration

• Work closely with R&D, Quality Assurance, Manufacturing, Supply Chain, Medical Affairs, and Commercial teams.
• Support responses to health authority questions, deficiency letters, and regulatory inquiries.
• Participate in product development and launch activities from a regulatory perspective.

Documentation & Compliance

• Prepare and maintain CTD/eCTD dossiers and regulatory documentation.
• Review labeling, packaging artwork, product information, and promotional materials for regulatory compliance.
• Ensure accurate maintenance of regulatory records and databases.

Audit & Inspection Support

• Support regulatory inspections, audits, and compliance assessments.
• Assist in implementing corrective and preventive actions (CAPA) related to regulatory observations.
• Maintain inspection readiness and documentation compliance.

Required Qualifications

• B.Pharma/M.Pharma/Bsc/Msc/BE/B.Tech Chemical

Experience

• 4–10 years of experience in Pharmaceutical Regulatory Affairs.
• Hands-on experience with global regulatory submissions and product registrations.
• Experience working with regulated markets such as USFDA, EMA, MHRA, Health Canada, TGA, GCC, ASEAN, LATAM, and ROW markets.

Function

Regulatory Affairs | Regulatory Compliance | Product Registration | Global Regulatory Operations