Title:

Regulatory Affairs Specialist

Position Summary

The Regulatory Affairs Specialist is responsible for preparing, reviewing, and submitting regulatory documentation required for product approvals, lifecycle management, and compliance across global markets. This role ensures that all pharmaceutical products meet applicable regulatory requirements and supports cross-functional teams to maintain high standards of quality, safety, and efficacy.

Key Responsibilities

Regulatory Submissions & Documentation

• Prepare, compile, and submit regulatory dossiers (e.g., IND, NDA, ANDA, CTA, MA, variations) to health authorities (e.g., FDA, EMA, MHRA, WHO).
• Ensure submissions comply with regional regulations (ICH, FDA CFR, EU guidelines).
• Maintain regulatory databases and document management systems (e.g., eCTD).
• Review labeling, packaging, artwork, and promotional materials for regulatory compliance.

Compliance & Quality Support

• Monitor changes to global regulatory requirements and assess impact on products and processes.
• Support internal audits and health authority inspections.
• Ensure ongoing compliance with GMP, GCP, GLP, and relevant quality standards.

Cross-Functional Collaboration

• Work closely with R&D, Quality Assurance, Manufacturing, Pharmacovigilance, and Supply Chain teams to support regulatory strategies.
• Provide regulatory guidance during product development, tech transfers, and post-approval changes.
• Participate in project teams to ensure timelines and regulatory deliverables are met.

Lifecycle Management

• Manage product variations, renewals, line extensions, and post-approval commitments.
• Maintain up-to-date product registrations and ensure timely renewals.
• Support regulatory intelligence activities and risk assessments.

Required Qualifications & Skills

Education

• Bachelor’s or Master's degree in Pharmacy, Life Sciences, Chemistry, Biotechnology, or related field.

Experience

• 2–5 years of regulatory affairs experience in the pharmaceutical or biopharmaceutical industry.
• Experience with eCTD submissions and regulatory systems is a plus.

Technical Skills

• Knowledge of global regulatory frameworks (FDA, EMA, ICH, WHO, country-specific agencies).
• Familiarity with drug development, CMC, clinical and non-clinical documentation.
• Strong understanding of GMP, GCP, and quality systems