Regulatory Affairs Specialist
4 days ago
Key Responsibilities:
- Regulatory Expertise: 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 (MOH) queries for dossiers submitted in the relevant territories.
- Compliance: 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.
- Documentation: Maintain comprehensive records of technical documentation, product registrations, and related expenses.
- Team Management: Lead and manage the regulatory affairs team, ensuring deadlines and regulatory goals are met.
Requirements:
- 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.
- Solid organizational skills for maintaining technical documentation and tracking expenses.
- Team management experience, with the ability to lead, mentor, and develop a high-performing team.
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.
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