Compliance Expert

5 days ago

Gulbarga, Karnataka, India beBeeRegulatory Full time ₹ 18,00,000 - ₹ 25,00,000

Regulatory Affairs Specialist Job Description

  • Job Overview:

We are seeking an experienced Regulatory Affairs professional to join our team.

  • Key Responsibilities:
  • Prepare, review, and submit regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
  • Evaluate international, federal, and local regulatory requirements for pharmaceuticals and medical devices.
  • Collaborate 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.
  • Work closely 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.
  • Requirements:
  • Expertise in both pharmaceutical and medical device regulatory compliance.
  • Strong understanding of regulatory requirements across global health authorities.
  • Excellent communication and collaboration skills.
  • Ability to work effectively in a team environment.
  • Strong problem-solving and analytical skills.
  • Proficiency in Microsoft Office Suite.
  • Ability to maintain confidentiality and handle sensitive information.
  • Adaptability and flexibility in a fast-paced environment.
  • Strong attention to detail and ability to multitask.
  • Benefits:
  • Competitive salary and benefits package.
  • Opportunities for career growth and professional development.
  • Collaborative and dynamic work environment.
  • Recognition and rewards for outstanding performance.

If you are a motivated and detail-oriented individual with a passion for regulatory affairs, we encourage you to apply for this exciting opportunity.

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