We are looking for a detail-oriented Regulatory Affairs Executive to support regulatory submissions, documentation, compliance activities, and communication related to pharmaceutical products.
Key Responsibilities
- Prepare and maintain regulatory documentation for pharmaceutical products.
- Support preparation and submission of regulatory dossiers.
- Review technical documents for completeness and regulatory compliance.
- Coordinate with R&D, Quality, Manufacturing, and other internal teams.
- Track regulatory submissions, approvals, queries, and commitments.
- Support responses to regulatory authority questions.
- Maintain regulatory databases and submission records.
- Monitor changes in applicable regulatory requirements and guidelines.
- Ensure regulatory documents are maintained accurately and within required timelines.
- Assist with product registrations, renewals, variations, and post-approval activities.
- Prepare regulatory reports and status updates for management.
Required Skills
- Knowledge of pharmaceutical regulatory processes.
- Understanding of regulatory documentation and submission requirements.
- Strong documentation and organizational skills.
- Good written and verbal communication.
- Strong attention to detail.
- Ability to manage multiple regulatory activities and deadlines.
- Good knowledge of Microsoft Office.
Education
Bachelor's/Master's degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related field.
Key Competencies
- Regulatory Affairs
- Documentation
- Compliance
- Communication
- Research & Analysis
- Time Management
- Attention to Detail
