Regulatory Affairs Compliance Manager

1 day ago

Vellore, Tamil Nadu, India beBeeRegulatoryAffairs Full time ₹ 15,00,000 - ₹ 25,00,000
Job Title:

Regulatory Affairs Specialist Med/Pharma

Location: Remote

Position Overview:

We are seeking an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring compliance with applicable regulations (FDA, EMA, CDSCO, MHRA, ISO 13485, ICH guidelines). The ideal candidate will have a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and commercialization.

Key Responsibilities:

  • Prepare, review, and submit regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
  • Ensure compliance with international, federal, and local regulatory requirements across pharmaceuticals and medical devices.
  • Interact with regulatory authorities (FDA, EMA, CDSCO, MHRA, Notified Bodies) 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.
  • Collaborate 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.
Required Skills and Qualifications:

The ideal candidate will possess:

  • Strong experience in regulatory affairs, preferably in pharmaceutical and medical device industries.
  • Excellent knowledge of relevant regulatory guidelines and frameworks (FDA, EMA, CDSCO, MHRA, ISO 13485, ICH).
  • Proven track record of successfully managing regulatory submissions, audits, and inspections.
  • Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
  • Ability to maintain confidentiality and handle sensitive information.
  • Excellent problem-solving and analytical skills, with the ability to think critically and strategically.
Benefits:

This is a remote opportunity that offers:

  • Flexibility to work from anywhere
  • A competitive compensation package
  • Opportunities for career growth and professional development
  • A dynamic and supportive work environment

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