Regulatory Affairs Specialist – eCTD Submissions

6 days ago

Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 28,00,000
Regulatory Affairs CMC Professional

The role of a Regulatory Affairs CMC Professional involves supporting US FDA submissions and lifecycle management activities.

Key Responsibilities:

  • Preparation, review, and compilation of regulatory submissions (ANDAs, NDAs, supplements, amendments, deficiency responses, annual reports, PADER) in eCTD format are crucial aspects of the job.
  • Maintenance of compliance with US FDA and ICH requirements, including post-approval regulatory filing deadlines, is essential.
  • A key function is the authorship and review of high-quality CMC documentation, Module 3, and Module 2.3 Quality Overall Summary (QoS).
  • Labelling component management, evaluation, and approval for changes to approved products for regulatory impact are significant responsibilities.
  • Tech document review, such as specifications, analytical procedures, batch records, method validation reports, and stability data, requires attention to detail.
  • Supporting regulatory strategy by identifying critical issues, responding to FDA queries, and ensuring timely submission of responses is vital.
  • Change control reviews from global manufacturing partners for regulatory impact assessment are necessary.
  • Staying current with FDA guidance, ICH regulations, pharmacopoeial requirements, and industry updates is important.

Requirements:

  • A Bachelor's/Master's degree in Pharmacy, Life Sciences, or related field is required.
  • Experience in Regulatory Affairs, preferably with US FDA submissions, typically ranges from 3 to 7 years.
  • Strong knowledge of eCTD submissions, CMC requirements, and US labeling is expected.
  • Excellent oral and written communication skills are essential.
  • The ability to work independently and in a team environment is necessary.
  • Proficiency in Microsoft Office Suite with Microsoft Word and Excel is required.
  • Attention to detail, excellent communication, and cross-functional collaboration skills are essential.

This position offers an opportunity to develop your skills in regulatory affairs, working closely with cross-functional teams to ensure compliance and success in product submissions.

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