Senior Regulatory Compliance Professional

2 days ago


Kottayam, Kerala, India beBeeRegulatory Full time ₹ 10,04,000 - ₹ 14,19,000
Regulatory Affairs Specialist Job Description

The ideal candidate will possess a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and commercialization.

Key Responsibilities:

  • Preparing, reviewing, and submitting regulatory filings to global health authorities
  • Ensuring compliance with international, federal, and local regulatory requirements across pharmaceuticals and medical devices
  • Interacting with regulatory authorities during product submissions, inspections, and audits
  • Developing and maintaining regulatory strategies to support new product development and lifecycle management
  • Reviewing labeling, promotional materials, and product packaging for compliance with applicable regulations

Additional Responsibilities:

  • Maintaining up-to-date knowledge of regulatory changes, guidelines, and industry best practices
  • Supporting quality systems in alignment with ISO 13485, ICH, and FDA QSR standards
  • Collaborating with R&D, Quality, Manufacturing, and Clinical teams to integrate regulatory requirements into product development

Requirements:

  • Strong analytical and problem-solving skills
  • Excellent communication and project management skills
  • Ability to work in a fast-paced environment and prioritize multiple tasks

Benefits:

  • Competitive salary and benefits package
  • Opportunities for career growth and professional development
  • A dynamic and supportive work environment


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