Regulatory Compliance Expert

2 days ago

Lucknow, Uttar Pradesh, India beBeeRegulatoryAffairs Full time ₹ 60,00,000 - ₹ 1,20,00,000

Job Title: Regulatory Affairs Specialist

Description:

We are seeking an accomplished professional to assume a pivotal role in ensuring our products comply with international, federal, and local regulatory requirements. The ideal candidate will possess expertise in both pharmaceutical and medical device regulatory submissions, product lifecycle management, and cross-functional collaboration.

Key Responsibilities:

  • Prepare, review, and submit regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
  • E nsure compliance with relevant regulatory standards across the pharmaceutical and medical devices sectors.
  • Interact with regulatory authorities during product submissions, inspections, and audits.
  • Develop and maintain regulatory strategies to support new product development and lifecycle management.
  • Review labeling, promotional materials, and product packaging for compliance with applicable regulations.
  • Maintain up-to-date knowledge of regulatory changes, guidelines, and industry best practices to ensure organizational compliance.
  • Support quality systems in alignment with ISO 13485, ICH, and FDA QSR standards.
  • Collaborate with R&D, Quality, Manufacturing, and Clinical teams to integrate regulatory requirements into product development.
  • Assist in responding to regulatory queries, deficiency letters, and inspection findings.
  • Manage regulatory documentation archives and maintain compliance records for audits and inspections.

About This Role:

This position offers an exciting opportunity to join a dynamic team dedicated to delivering high-quality products that meet rigorous regulatory standards. As a Regulatory Affairs Specialist, you will play a critical role in shaping our company's regulatory strategy and ensuring compliance with ever-changing regulatory requirements.

What We Offer:

In return for your skills and experience, we offer a competitive compensation package, opportunities for professional growth and development, and a collaborative work environment that values innovation and excellence.

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