Sr. Regulatory Affairs

EaseBiz Fintech Solutions

  • Ahmedabad, Gujarat
  • Permanent
  • Full-time
  • 9 days ago
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

EaseBiz Fintech Solutions