Sr. Regulatory Affairs

13 hours ago

Ahmedabad, India EaseBiz FinTech Solutions LLP Full time

Job Description:

A Sr. Regulatory Affairs professional in a Healthcare Pvt. Ltd. is responsible for the preparation, review, and submission of CTD/ACTD/eCTD dossiers, WHO-GMP, ICH, and country-specific requirements for regions such as ROW, LATAM, SEA, Africa, and Pacific. The role involves mentoring junior Regulatory Affairs staff and implementing process improvements to ensure compliance with regulatory standards.

Responsibilities:
  • Prepare, review, and submit CTD/ACTD/eCTD dossiers.
  • Ensure compliance with WHO-GMP, ICH, and country-specific regulatory requirements.
  • Manage regulatory submissions for regions including ROW, LATAM, SEA, Africa, and Pacific.
  • Mentor junior Regulatory Affairs staff.
  • Implement process improvements to enhance regulatory compliance.
Qualifications:
  • Bachelor's or Master's degree in Pharmacy, Life Sciences, or related field.
  • Minimum of 5 years of experience in Regulatory Affairs within the healthcare industry.
  • Strong knowledge of regulatory guidelines and requirements for CTD/ACTD/eCTD submissions.
  • Experience in working with WHO-GMP, ICH, and country-specific regulations.
Skills:
  • Regulatory Affairs Compliance
  • CTD/ACTD/eCTD Submissions
  • WHO-GMP Knowledge
  • ICH Guidelines
  • Process Improvement
  • Mentoring and Training
. Skillset Required: CTD/ACTD/eCTD, WHO-GMP, ICH, ICH Guidelines, Mentoring , Training

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