
Expert Regulatory Compliance Professional
4 days ago
Job Title: Regulatory Affairs Specialist
Job SummaryWe are seeking an experienced Regulatory Affairs Specialist to join our team. In this role, you will be responsible for managing the regulatory process for Pharmaceutical Finished Formulations across various regions.
Main Responsibilities:- Manage the regulatory process for Pharmaceutical Finished Formulations across CIS, LATAM, and Africa
- Dossier Management: Compile and review ACTD and CTD dossiers to ensure accuracy and compliance
- MOH Query Response: Address and respond to any Ministry of Health queries for dossiers submitted in the relevant territories
- Compliance Review: Review product artworks and samples to ensure compliance with regulatory requirements
- International Coordination: Liaise with international agents for dossier submission, follow-up, and product registration
- Proven expertise in the regulatory field of pharmaceutical finished formulations for CIS, LATAM, and African markets
- Experience in compiling and reviewing ACTD and CTD dossiers
- Proficiency in handling MOH queries and ensuring timely responses
- Strong attention to detail in checking product artwork and samples for regulatory compliance
- Ability to effectively coordinate with international agents and manage the dossier submission and registration processes
This role offers a challenging and rewarding career opportunity for individuals with a strong background in regulatory affairs. If you are passionate about working in a dynamic environment and have the skills to succeed in this role, we encourage you to apply.
Preferred Qualifications:- Bachelor's or Master's degree in Pharmacy, Regulatory Affairs, or a related field
- Minimum 5 years of experience in regulatory affairs in the pharmaceutical industry
- Strong understanding of international regulatory requirements for CIS, LATAM, and Africa regions
- Excellent communication and coordination skills with cross-functional teams and international agents
We are a leading organization in the pharmaceutical industry, committed to delivering high-quality products and services. Our team is dedicated to excellence and innovation, and we are looking for talented individuals who share our values.
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