Regulatory Affairs CMC Specialist

1 day ago

Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 25,00,000 - ₹ 35,00,000

As a Regulatory Affairs CMC Associate, you will play a key role in supporting US FDA submissions and lifecycle management activities. This dynamic position offers the opportunity to enhance your career while working collaboratively as part of a dedicated team.

Key Responsibilities:
  • Prepare and Review Regulatory Submissions
  • Maintain Compliance with US FDA Requirements
  • Author and Review High-Quality CMC Documentation
  • Manage Labelling Components and Evaluate Changes
  • Review Technical Documents and Support Regulatory Strategy

To succeed in this role, you will stay current with industry updates, including FDA guidance, ICH regulations, and pharmacopoeial requirements. You will work independently and collaboratively, leveraging your skills and experience to drive success.

Required Skills and Qualifications:
  • Proven experience in regulatory affairs, preferably in CMC documentation and submission preparation
  • Strong knowledge of FDA regulations and guidelines
  • Excellent communication and teamwork skills
  • Ability to work under pressure and meet deadlines
  • Experience with labelling components and technical document review

You will have the opportunity to work in a fast-paced environment, collaborating with cross-functional teams to deliver high-quality results. As a successful Regulatory Affairs Associate, you will contribute to the growth and success of our organization.

This is an exciting opportunity to take your career to the next level, working on challenging projects and contributing to the development of new processes and procedures.

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