Manager- Regulatory Affairs-International

Role Overview: As a Manager- Regulatory Affairs-International, your primary purpose will be to manage and oversee the preparation, review, and timely submission of regulatory dossiers in CTD and ACTD formats for international markets. You will ensure ongoing regulatory compliance and support product lifecycle management across ROW and emerging markets. Key Responsibilities: - Prepare and review Common Technical Document (CTD) and ASEAN Common Technical Document (ACTD) dossiers. - Coordinate with manufacturing sites and R&D to gather necessary data and documents for regulatory submissions. - Ensure plant compliance with regulatory requirements and facilitate timely implementation of changes. - Meet monthly regulatory submission targets and respond to queries within specified timelines. - Perform gap analysis and regularly update master regulatory data. - Review regulatory-related documents including Change Controls, Stability Protocols, Clinical Trial Protocols, and Artwork. - Gather feedback from international markets on variations and ensure their timely submission. - Manage dossier renewals and maintain up-to-date master documentation. - Conduct regular follow-ups with manufacturing units for required documentation and participate in review meetings. - Track, compile, and review documents for upcoming product filings in ROW and emerging markets. Qualifications Required: - Education: M.Pharm / M.Sc. in Biotechnology or related field - Experience: Minimum 6-8 years of experience in Regulatory Affairs, with a strong focus on international market submissions - Technical Knowledge & Skills: - Expertise in CTD, ACTD, and eCTD dossier formats - In-depth knowledge of ICH guidelines and regulatory validation requirements - Familiarity with international regulatory filings including USFDA, EMA, WHO Prequalification, and MCC (South Africa) - Experience in handling regulatory submissions for biological and biotech products - Exposure to both in-licensing and out-licensing of regulatory dossiers Additional Company Details: The company focuses on effective time management, attention to detail, problem-solving skills, cross-functional collaborations, strong communication skills, and team leadership in a collaborative environment.,