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Regulatory Compliance Specialist

3 weeks ago

Ajmer, Rajasthan, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 25,00,000

Job Opportunity:

We are seeking a highly skilled Regulatory Compliance Specialist to join our team.

The role involves preparing, reviewing, and submitting regulatory documents to global health authorities, ensuring adherence to applicable regulations.

Key Responsibilities:

  • Regulatory Filing: Prepare, review, and submit regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
  • Compliance Oversight: Ensure compliance with international, federal, and local regulatory requirements across pharmaceuticals and medical devices.
  • Regulatory Liaison: Interact with regulatory authorities during product submissions, inspections, and audits.
  • Strategic Planning: Develop and maintain regulatory strategies to support new product development and lifecycle management.

Maintain up-to-date knowledge of regulatory changes, guidelines, and industry best practices to ensure organizational compliance. Collaborate with cross-functional teams to integrate regulatory requirements into product development.

Skill Requirements:

  • Proven experience in regulatory affairs with expertise in pharmaceutical and medical device regulatory compliance.
  • Excellent communication and interpersonal skills.
  • Able to work in a fast-paced environment with multiple priorities and deadlines.