Senior Pharmaceutical and Medical Device Regulatory Compliance Professional

4 days ago

Nellore, Andhra Pradesh, India beBeeRegulatory Full time ₹ 9,00,000 - ₹ 12,00,000
Regulatory Affairs Specialist

We are seeking a highly skilled Regulatory Affairs professional to lead our pharmaceutical and medical device regulatory compliance efforts.

  • Developed, reviewed, and submitted regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications, ensuring timely and compliant submissions.
  • Collaborated with cross-functional teams to ensure compliance with international, federal, and local regulatory requirements across pharmaceuticals and medical devices.

The ideal candidate will have a strong background in regulatory submissions, product lifecycle management, and strategic planning to support product development, registration, and commercialization.

Key Responsibilities:

  • Prepare, review, and submit regulatory documentation to global health authorities, maintaining a high level of accuracy and attention to detail.
  • Ensure compliance with applicable regulations (FDA, EMA, CDSCO, MHRA, ISO 13485, ICH guidelines) through thorough reviews and assessments.
  • Interact with regulatory authorities during product submissions, inspections, and audits, effectively communicating regulatory strategies and outcomes.
  • Develop and maintain regulatory strategies to support new product development and lifecycle management, aligning with business objectives.
  • Review labeling, promotional materials, and product packaging for compliance, ensuring seamless integration with product launches.
  • Maintain up-to-date knowledge of regulatory changes, guidelines, and industry best practices, applying this expertise to drive regulatory excellence.
  • Support quality systems in alignment with standards, promoting a culture of continuous improvement.
  • Collaborate with R&D, Quality, Manufacturing, and Clinical teams to integrate regulatory requirements, driving project success.
  • Assist in responding to regulatory queries and inspection findings, effectively resolving issues and mitigating risk.

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