To manage regulatory activities and ensure compliance with national and international regulations governing pharmaceutical products throughout their lifecycle.
Key Responsibilities
- Develop and implement regulatory strategies for product registration and approval.
- Prepare, review, and submit regulatory dossiers and applications to health authorities.
- Liaise with regulatory agencies such as:
- U.S. Food and Drug Administration
- Central Drugs Standard Control Organization
- Medicines and Healthcare products Regulatory Agency
- Monitor changes in regulatory requirements and assess their impact on products and business operations.
- Ensure compliance with Positive Manufacturing Practices (GMP), labeling requirements, and pharmacovigilance regulations.
- Coordinate with R&D;, quality assurance, clinical, manufacturing, and marketing teams.
- Manage product registrations, renewals, variations, and post-approval changes.
- Review promotional and advertising materials for regulatory compliance.
- Support regulatory inspections and audits.
- Maintain regulatory documentation and records.
Required Qualifications
- Bachelor's or Master's degree in:
- Pharmacy
- Pharmaceutical Sciences
- Life Sciences
Required Skills
- Knowledge of pharmaceutical regulations and guidelines.
- Regulatory submission expertise (CTD/ACTD).
- Understanding of GMP, GCP, and pharmacovigilance requirements.
- Project management skills.
- Technical writing and document preparation.
- Risk assessment and problem-solving abilities.
- Communication and negotiation skills.
- Attention to detail and analytical thinking.
Experience
- Typically, 3+ years of experience in regulatory affairs, quality assurance, clinical research, or pharmaceutical compliance.
- Prior experience handling product registrations and regulatory submissions is often required.
- Team leadership experience is preferred for managerial positions.