Regulatory Affairs Executive
1 week ago
Regulatory Affairs Executive : (BKM) is seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approval from the regulated market. In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks, eCTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like Extedo, Lorenz, Veeva Vault RIM Job Responsibility : Prepare, compile, and review eCTD dossiers for submissions (e.G., ANDA/NDA /MAA/ANDS). Coordinate with cross-functional teams (QA, QC, R&D, Manufacturing, Packaging) for accurate documentation. Submit applications to US FDA, HC, EMA, and other authorities in compliance with regional requirements. Compile and validate submissions using tools such as Extedo, Lorenz docuBridge, or equivalent. Ensure completeness and technical accuracy of eCTD sequences. Troubleshoot validation issues before final submission. Prepare and manage post-approval changes (CMC variations, labeling updates, packaging changes). Submit supplements, amendments, and variations in accordance with regulatory guidelines (FDA’s PAS, EMA's Type IA/IB/II). Collaborate with internal departments to gather data and draft scientifically sound responses. Stay updated with changes in FDA, EMA, and ICH guidelines. Maintain regulatory databases, submission trackers, and approval records. Participate in audits and support regulatory inspections. Required Qualification & Skills: Bachelor's / Master’s degree in Pharmacy or related field. 1.5 – 2 years of relevant experience in Regulatory Affairs for regulated markets (Health Canada/US/EU) In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks. Strong understanding of dossier structure, eCTD publishing, and submission timelines.
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Regulatory Affairs Executive
3 weeks ago
Ahmedabad, India BKM Health Pvt Ltd Full timeRegulatory Affairs Executive :(BKM) is seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approval from the regulated market. In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks, eCTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like...
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Regulatory Affairs Executive
3 weeks ago
Ahmedabad, India BKM Health Pvt Ltd Full timeRegulatory Affairs Executive :(BKM) is seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approval from the regulated market. In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks, eCTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like...
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Regulatory Affairs Executive
3 weeks ago
Ahmedabad, India BKM Health Pvt Ltd Full timeRegulatory Affairs Executive :(BKM) is seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approval from the regulated market. In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks, eCTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like...
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Regulatory Affairs Executive
1 week ago
Ahmedabad, India BKM Health Pvt Ltd Full timeRegulatory Affairs Executive :(BKM) is seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approval from the regulated market. In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks, eCTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like...
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Regulatory affairs executive
3 weeks ago
Ahmedabad, India BKM Health Pvt Ltd Full timeRegulatory Affairs Executive :(BKM) is seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approval from the regulated market. In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks, e CTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like...
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Regulatory Affairs Executive
3 weeks ago
Ahmedabad, India BKM Health Pvt Ltd Full timeRegulatory Affairs Executive : (BKM) is seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approval from the regulated market. In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks, eCTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like...
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Regulatory Affairs
3 days ago
Ahmedabad, Gujarat, India Medipharma Konnect Full timeWe are hiring Regulatory Affairs (RA) Executive / Manager for a leading Pharma company in Ahmedabad. The candidate will be responsible for dossier preparation, product registration, regulatory submissions, and maintaining compliance with international guidelines (ROW / LATAM / Africa). Must have hands-on experience in RA documentation for pharma...
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Regulatory Affairs Executive
2 weeks ago
Ahmedabad, Gujarat, India, Gujarat BKM Health Pvt Ltd Full timeRegulatory Affairs Executive :(BKM) is seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approval from the regulated market. In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks, eCTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like...
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Regulatory Affairs Executive
6 days ago
Ahmedabad, Gujarat, India CLAPS Industries Private Limited Full timeCompany DescriptionCLAPS Industries Private Limited is a global pharmaceutical company, founded by a visionary team of seasoned professionals from the pharmaceutical and healthcare sectors. Focused on delivering high-quality healthcare products and services worldwide, CLAPS empowers accessibility through affordable and effective medications. The company has...
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Regulatory Affairs
6 days ago
Ahmedabad, Gujarat, India VHA Biopharma Private Limited Full timeCompany DescriptionJaidev Pharma Placement is a renowned recruitment agency with a proven track record of over two decades in Pharmaceutical Sales, hiring, recruitment, and training across India. We specialize in providing tailored human resources solutions to help organizations achieve their goals while supporting employees' career growth. Our expertise...
