Senior Regulatory Affairs Professional

3 days ago

Jamnagar, Gujarat, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 20,00,000
Regulatory Compliance Expert

We are seeking an accomplished professional with expertise in pharmaceutical and medical device regulatory compliance.

  • Prepared, reviewed, and submitted regulatory filings for various products, ensuring adherence to international, federal, and local regulations.
  • Maintained knowledge of regulatory requirements, guidelines, and industry best practices to ensure organizational compliance.

The ideal candidate will possess a strong background in regulatory submissions, product lifecycle management, and collaboration with cross-functional teams to support product development and commercialization.

Maintaining up-to-date knowledge of regulatory changes is crucial. Key responsibilities include:

  1. Developing and maintaining regulatory strategies to support new product development and lifecycle management.
  2. Reviewing labeling, promotional materials, and product packaging for compliance with applicable regulations.
  3. Collaborating with R&D, Quality, Manufacturing, and Clinical teams to integrate regulatory requirements into product development.
  4. Responding to regulatory queries, deficiency letters, and inspection findings.

This role involves working closely with global health authorities (FDA, EMA, CDSCO, MHRA) and ensuring compliance with applicable regulations. A strong understanding of regulatory submissions, product lifecycle management, and collaboration is required.

Benefits:

  • Opportunity to work on complex regulatory projects.
  • Collaborative team environment.
  • Professional growth and development.

About the Role:

This position requires a high level of technical expertise, attention to detail, and excellent communication skills. If you are a motivated professional looking to make a meaningful contribution, we encourage you to apply.

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