Regulatory Affairs Executive (Walk-in Interview)
About Pharmazone
Pharmazone is a dynamic and growing organization committed to excellence in the pharmaceutical industry. We are actively seeking a dedicated and experienced Regulatory Affairs Executive to join our team in Sola. If you possess a strong background in regulatory documentation and submissions and are looking to advance your career, we invite you to explore this opportunity with us.
About the Role
As a Regulatory Affairs Executive at Pharmazone, you will play a crucial role in supporting our regulatory affairs department, ensuring the timely delivery of projects, and maintaining meticulous documentation standards. You will be instrumental in the technical review of product documents, comprehensive dossier preparation, and managing submissions for various global markets. This position requires a proactive individual with a keen eye for detail and a thorough understanding of regulatory guidelines.
Key Responsibilities
- Provide robust support to the regulatory affairs department, operating effectively at a senior executive level.
- Manage project timelines efficiently to ensure successful and prompt delivery of all regulatory tasks.
- Oversee and maintain comprehensive documentation pertinent to regulatory affairs processes.
- Conduct technical reviews of product documents received from clients for registration purposes.
- Perform thorough gap analysis on documents and data required for dossier preparation.
- Draft and meticulously review dossiers for drug substances, drug products, and administrative sections.
- Regularly update and enhance the regulatory guidelines knowledge database to ensure compliance with the latest regulations.
- Collaborate effectively with cross-functional teams to ensure all regulatory requirements are met throughout the dossier submission and product lifecycle management processes.
- Prepare and review comprehensive responses to deficiency letters issued by health authorities during the evaluation of marketing authorization and drug registration procedures.
- Execute regulatory submission procedures for key international markets, including the US (ANDA), Europe, and other Rest of the World (ROW) markets.
Required Qualifications & Experience
- Education: Postgraduate degree (M.Pharma) in any specialization.
- Experience: A minimum of 2 to 6 years of relevant experience in Regulatory Affairs within the pharmaceutical industry.
Walk-in Interview Details
We are conducting a walk-in interview drive for this position. Interested candidates meeting the qualifications are encouraged to attend:
- Dates: 16th August – 21st August
- Time: 9:30 AM – 5:30 PM
- Venue: Pharmazone, 401 Safalya Elegance, Science City Road, Sola.
Contact Information
For any queries or further information, please contact our HR Team at 9512540023.
