We are looking for an experienced Regulatory Affairs professional with 3–4 years of relevant experience to manage regulatory submissions, documentation, compliance activities, and coordination with regulatory authorities.
Key Responsibilities
- Prepare, review, and maintain regulatory dossiers and submissions.
- Coordinate regulatory submissions, approvals, renewals, and variations.
- Ensure compliance with applicable regulatory requirements and guidelines.
- Review technical and regulatory documents for accuracy and completeness.
- Coordinate with internal departments such as R&D;, Quality, Manufacturing, and QA.
- Track regulatory submissions, queries, commitments, and approvals.
- Support responses to regulatory authority queries and deficiencies.
- Maintain regulatory databases, records, and documentation.
- Monitor changes in applicable regulations and communicate relevant updates to stakeholders.
Required Qualifications
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Chemistry, or a related field.
- 3–4 years of experience in Regulatory Affairs.
- Good knowledge of regulatory documentation and submission processes.
- Strong written and verbal communication skills.
- Good attention to detail and documentation skills.
- Ability to coordinate with cross-functional teams and manage multiple regulatory activities.
What We Offer
- Competitive salary based on experience and skills.
- Opportunity to work on diverse regulatory projects.
- Qualified growth and learning opportunities.
- Collaborative work environment.