Senior Regulatory Affairs Specialist

2 days ago

Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 25,00,000
Regulatory Affairs Manager Job Summary

This is a high-profile position responsible for leading the submission of annual reports, facility registrations, and product renewals. The successful candidate will also oversee staff members and act as a primary point of contact for specific submission execution or annual reporting tasks.

Key Responsibilities:
  • Lead the preparation and submission of annual reports, facility registrations, and product renewals to ensure compliance with regulatory requirements
  • Oversee and coordinate the work of staff members involved in regulatory submissions, providing guidance and support as needed
  • Interact with authors/reviewers and subject matter experts to deliver CMC documents required for regulatory submissions
  • Develop and implement submission content plans for CMC submissions, ensuring timely and accurate delivery
  • Coordinate the preparation and collection of CMC country-specific documents, ensuring accuracy and completeness
  • Document and archive CMC and/or Device submissions and related communications in a document management system
  • Establish and maintain CMC product and/or Device timelines at the direction of product lead
  • Interface with the regulatory operations team to ensure seamless communication and collaboration
Requirements:
  • A Doctorate degree OR Master's degree with 5 years of minimum experience in manufacturing, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Bachelor's degree with 7 years of minimum experience in manufacturing, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry
  • Preferred Qualifications: BS degree in Life Science, experience managing or overseeing staff members, experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development

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