Regulatory Affairs Specialist

6 days ago


Gurgaon, Haryana, India Lifelancer Full time
Job Overview

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Lifelancer, a talent-hiring platform in Life Sciences, Pharma and IT. As an Associate Regulatory Affairs Specialist, you will play a critical role in supporting the Regulatory Affairs function and systems.

This is an entry-level position that requires collaboration with cross-functional teams to direct completion of regulatory requirements for successful new product registrations or changes to existing products. You will prepare and submit documentation needed for global registrations, involving regular high-level analysis and interpretation of government medical device regulation and guidance.

Your key responsibilities will include strategy development, project management of deliverables, and tracking through to completion. Additionally, you will have experience in promotional materials, Veeva training systems, MAP, coordination/routings for approval in US FDA or EU MDR in Medical devices domain.

Responsibilities
  • Support the Regulatory Affairs function and systems
  • Collaborate with cross-functional teams to direct completion of regulatory requirements
  • Prepare and submit documentation needed for global registrations
  • Analyze and interpret government medical device regulation and guidance
  • Develop strategies for successful new product registrations or changes to existing products
  • Manage projects and track deliverables to completion
Requirements

To be successful in this role, you should have experience in:

  • Promotional materials
  • Veeva training systems
  • MEDDAP (Medical Device Data Management Application)
  • MAP (Medical Device Alert System)
  • Coordination/routings for approval in US FDA or EU MDR in Medical devices domain
Benefits

We offer a competitive salary of ₹12-15 lakhs per annum, depending on experience. Our hybrid working model allows for flexibility and work-life balance. We also provide opportunities for professional growth and development.

About Us

Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. We connect talented professionals with opportunities in pharma, biotech, health sciences, healthtech and IT domains. Apply now and take the first step towards your dream career



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