Compliance Expert

12 hours ago

Vadodara, Gujarat, India beBeeRegulatory Full time ₹ 80,00,000 - ₹ 1,20,00,000

Job Title: Regulatory Compliance Expert

Location: Remote

 

Job Description:

We are seeking an experienced professional with expertise in pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring compliance with applicable regulations.

Key Responsibilities:

  • Prepared, reviewed, and submitted regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
  • Ensured compliance with international, federal, and local regulatory requirements across pharmaceuticals and medical devices.
  • Interacted with regulatory authorities during product submissions, inspections, and audits.
  • Developed and maintained regulatory strategies to support new product development and lifecycle management.
  • Reviewed labeling, promotional materials, and product packaging for compliance with applicable regulations.
  • Maintained up-to-date knowledge of regulatory changes, guidelines, and industry best practices to ensure organizational compliance.
  • Supported quality systems in alignment with ISO 13485, ICH, and FDA QSR standards.
  • Collaborated with R&D, Quality, Manufacturing, and Clinical teams to integrate regulatory requirements into product development.
  • Assisted in responding to regulatory queries, deficiency letters, and inspection findings.
  • Managed regulatory documentation archives and maintained compliance records for audits and inspections.

 

Required Skills and Qualifications:

• Experience in regulatory affairs with a strong background in pharmaceutical and medical device regulatory compliance.

• Strong knowledge of regulatory requirements and guidelines (FDA, EMA, CDSCO, MHRA, ISO 13485, ICH).

• Excellent communication and collaboration skills.

• Ability to work independently and as part of a team.

 

Benefits:

• Opportunity to work on challenging projects and develop your career.

• Collaborative and dynamic work environment.

• Competitive salary and benefits package.

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