Job Posting: Regulatory Affairs Specialist at Molex
About the Company:
Phillips Medisize, part of Molex, specializes in the design, development, and delivery of advanced drug delivery devices and connected health solutions. Serving leading pharmaceutical companies worldwide, we offer innovative and integrated solutions from strategy to launch. Our new Global Innovation and Development Center in Bangalore, India, is poised for growth in the Asian region.
Position Name:
Regulatory Affairs Specialist
Organization:
Molex
Location:
Bangalore
Salary:
₹45,000 – ₹115,000 per month
Experience:
5+ years
Qualifications:
- B.Pharm, M.Pharm, Pharm.D, MSc, BSc, Life Sciences
What You Will Do:
| Task | Description |
|---|---|
| Regulatory Strategy | Participate in the development of regulatory submission and approval strategies for multiple countries. |
| Regulatory Awareness | Maintain awareness and understanding of new and existing regulatory requirements. |
| Requirements Identification | Support identification of applicable regulatory requirements, their impact, and interpretation. |
| Strategy Execution | Execute regulatory strategies by applying requirements and generating necessary documentation. |
| Compliance Review | Review and ensure compliance of technical documentation. |
| Submission Preparation | Assemble regulatory submission packages and support the submission process. |
| Stakeholder Interaction | Interact with customers and regulatory authorities to ensure regulatory approval/clearance. |
| Documentation Maintenance | Maintain technical documentation to ensure continuous product conformity and approval. |
| Team Collaboration | Contribute to alignment between development, risk, usability, clinical, testing, and manufacturing teams. |
Meta Description:
Join Molex as a Regulatory Affairs Specialist in Bangalore. Experienced candidates apply now for a rewarding career.