Urgent Requirement For Regulatory Affairs Manager at Zambia, Africa

Dear Candidate,

BioMatrix Healthcare Private Limited, 100% export-oriented company headquartered at Ahmedabad, Gujarat, India, was established in 2007 with a thought of Supporting Life Worldwide. The company is engaged in R&D and manufacturing of oral solids, liquids, and dry syrups. Our manufacturing facility has been accredited by WHO-GMP, successfully completed an EU-GMP audit recently and complies with ANVISA, UKMHRA, and USFDA regulations. With a significant presence in African and CIS regions, we export our products to over 30 countries. We are now planning to expand our presence in Europe, Latin America and South East Asian markets. We have over 850 product registrations with more than 400 products under registrations across Europe, CIS and African countries. We currently have the following opportunity; if interested, kindly get in touch for further process.

Department: International Regulatory Affairs

Qualifications and Skills

B.pharm / M.pharm

• Regulatory Compliance (Mandatory skill): Expertise in maintaining compliance with local and international drug regulatory authorities of Different Countries
• The Zambia Medicines Regulatory Authority (ZAMRA) (Mandatory skill): Thorough understanding and experience with ZAMRA regulatory procedures and policies.

Job Location- Zambia, Lusaka

Roles and Responsibilities

• Overall responsibility for managing regulatory submissions for respecting Zone, query responding and product life-cycle maintenance for the companys portfolio.
• Leading a team of regulatory professionals.
• To plan, prepare and review of high-quality eCTD dossier, with support and guidance, assuring technical congruency and regulatory compliance, meeting agreed-upon timelines.
• Prepare Dossiers for different countries as per CTD and ACTD Format
• Evaluation, Verification & Proper Checking of DMF (Drug Master File) of API, BMR, BPR, Specifications, PDR & Checking of Bioequivalence Study Report (BE Report), Analytical Method Validation (AMV), etc…
• Review Guidelines for First time dossier preparation for any new country & renew application
• Ensuring planning and proper organization of regulatory activities and resources within the team.
• Independent interaction with the company’s overseas client for regulatory-related matters.
• Established a system of recording technical comments from various regulatory teams on change control imitated by R&D or manufacturing plant.