Regulatory Executive

Job Description:
We are seeking a skilled Pharma Regulatory Executive with expertise in evaluating, compiling, and responding to queries related to CTD (Common Technical Document) and eCTD (electronic Common Technical Document) dossiers for African markets. The ideal candidate will play a crucial role in ensuring compliance with international regulatory standards and driving the timely approval of pharmaceutical products.

Key Responsibilities:

• Dossier Compilation: Prepare and compile CTD and eCTD dossiers as per African regulatory requirements.
• Dossier Evaluation: Review and evaluate regulatory documentation to ensure accuracy, completeness, and compliance.
• Query Handling: Analyze and respond to regulatory authority queries efficiently and within deadlines.
• Compliance: Stay updated with regulatory guidelines and ensure all submissions align with current regulatory expectations.
• Collaborate with cross-functional teams, including R&D, QA, and manufacturing, to gather required documentation and resolve regulatory issues.
• Maintain and update regulatory records and documentation.

Required Qualifications and Skills:

• Education: Bachelors or Master’s degree in Pharmacy, Pharmaceutical Sciences, or related fields.
• Experience: 2-5 years of experience in regulatory affairs, specifically in CTD/eCTD dossier preparation for African markets.
• Technical Expertise: Strong understanding of CTD/eCTD formats and African regulatory guidelines – Tanzania, Nigeria, Zambia & Malawi, Cameroun and Mozambique will be given preference.
• Skills: Excellent communication, attention to detail, and organizational skills.
• Tools: Proficiency in English and Additional Languages. Hands on exposure to regulatory submission tools and software is a plus.

What We Offer:

• Competitive salary and benefits package.
• Opportunity to work in a dynamic and growing organization.
• Professional development and learning opportunities.

How to Apply:
Interested candidates can send their updated CVs to IndiaHR@neomedic.in or apply directly through Naukri.com.

Application Deadline: Open till vacancy fullfilled

Company Name: Neomedic India Private Limited