Compliance Specialist

3 days ago

Malappuram, Kerala, India beBeeRegulatory Full time ₹ 80,00,000 - ₹ 1,99,99,999

Key Player in Regulatory Compliance.

As a crucial member of our team, you will play a pivotal role in ensuring the regulatory compliance of pharmaceutical and medical device products. Your expertise will be instrumental in preparing, reviewing, and submitting regulatory documentation to ensure seamless product development, registration, and commercialization.

Main Responsibilities:
  • Regulatory Filings: Prepare, review, and submit regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications, to ensure timely and accurate submissions.
  • Compliance Management: Ensure adherence to international, federal, and local regulatory requirements across pharmaceuticals and medical devices, staying up-to-date with changing regulations and guidelines.
  • Regulatory Authority Interactions: Engage with regulatory authorities (FDA, EMA, CDSCO, MHRA, Notified Bodies) during product submissions, inspections, and audits, resolving any queries or deficiencies promptly.
  • Regulatory Strategies: Develop and maintain regulatory strategies to support new product development and lifecycle management, aligning with organizational goals and objectives.
  • Labeling and Promotional Materials: Review labeling, promotional materials, and product packaging for compliance with applicable regulations, ensuring accuracy and consistency.

You will work closely with R&D, Quality, Manufacturing, and Clinical teams to integrate regulatory requirements into product development, ensuring seamless execution and quality delivery. If you have a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration, we encourage you to apply for this exciting opportunity to shape the future of healthcare products.

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