Job Description

Company OverviewBBioMatrix 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 are grateful that you are interested in working with BioMatrix Healthcare Pt. Ltd. As we are moving further, we have arranged walk-in interview as per the details given below. Kindly go through the details and confirm your availability.Job OverviewWe are seeking a Regulatory Affairs Senior Manager at our Ahmedabad location. This is a full-time position requiring a minimum of 7 years of work experience. The candidate will be responsible for ensuring compliance with drug regulations, leading the regulatory affairs team, and supporting our expansion into new markets.Qualifications and SkillsB.pharm / M.pharm

• Regulatory Compliance (Mandatory skill): Expertise in maintaining compliance with local and international drug regulatory authorities.
• FDA Regulations (Mandatory skill): Thorough understanding and experience with FDA regulatory procedures and policies.

• 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.
• Renewal Application
• Ensuring planning and proper organization of regulatory activities and resources within the team.
• Independent interaction with the companys 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.

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