Sr. Regulatory Affairs
Sr. Regulatory Affairs
Posted on :
27-08-2025
Employer Active
1 Vacancy
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Job Description
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
Skills
CTD/ACTD/eCTD, WHO-GMP, ICH, ICH Guidelines, Mentoring , Training
Employment Type
Full Time
Key Skills
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