Regulatory Affairs Executive
5 days 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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Global Regulatory Compliance Specialist
1 week ago
bhavnagar, India beBeeRegulatoryAffairs Full timeRegulatory Affairs Professional RoleThis is a key position within our organization, responsible for overseeing regulatory submissions across multiple countries and product lines.
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Senior Regulatory Affairs Specialist
2 weeks ago
bhavnagar, India beBeeCompliance Full timeRegulatory Compliance OfficerKey aspects of this role involve maintaining company registration and licenses, providing support to all business units, managing Know Your Customer (KYC) and Anti-Money Laundering (AML) matters.Maintain registration and license;Provide compliance support to all business units;Manage KYC and AML matters, to implement controls...
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Bhavnagar, India Cadila Pharmaceuticals Limited Full timeAbout the Role Cadila Pharmaceuticals is seeking a dynamic and visionary Associate Vice President (AVP) – New Product Development to lead the strategic evaluation, development, and execution of innovative product opportunities across therapeutic segments. This senior leadership role will play a pivotal part in shaping the company’s growth trajectory...
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Assistant Manager
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Company Secretary Intern or Inter
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Bhavnagar, India FinGuru India Full timeAbout FinGuru Services India Pvt. Ltd. FinGuru Services India Pvt. Ltd. is a fast-growing financial services and consulting firm committed to delivering comprehensive solutions across investment advisory, taxation, compliance, and financial management. We pride ourselves on a culture of learning, collaboration, and professional growth. Our mission is to...
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Bhavnagar, India Amrit Cement Limited Full timeJob Description – Sr. Environment Executive / Sr. Officer / Sr. EngineerDepartment: EHSPosition Title: Sr. Executive / Sr. Officer / Sr. Engineer – EnvironmentReports to: Manager / HOD – Plant HeadLocation: Meghalaya – PlantExperience: 4–5 YearsIndustry Preference: Cement Industry (Preferred) / Heavy Industry / Manufacturing Plant1. Job ObjectiveTo...
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Senior Executive
4 weeks ago
Bhavnagar, India Amrit Cement Limited Full timeJob Description – Sr. Environment Executive / Sr. Officer / Sr. EngineerDepartment: EHSPosition Title: Sr. Executive / Sr. Officer / Sr. Engineer – EnvironmentReports to: Manager / HOD – Plant HeadLocation: Meghalaya – PlantExperience: 4–5 YearsIndustry Preference: Cement Industry (Preferred) / Heavy Industry / Manufacturing Plant1. Job ObjectiveTo...
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Senior Executive
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Bhavnagar, India LUPIN Full timeWe are seeking a skilled CSV SME to lead and manage Computer System Validation CSV activities in compliance with GxP cGMP and global regulatory standards GAMP5 21 CFR Part 11 EU Annex-11 WHO Annex-5 The ideal candidate will ensure robust validation documentation and lifecycle management of GxP computerized systems across Quality R D and Manufacturing domains...
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Senior QA Executive
1 week ago
bhavnagar, India Adrta Technologies Private Limited Full timeThe Senior QA Executive / Senior QA Associate ensures that the company's pharma software products meet GxP, 21 CFR Part 11, Annex 11, GAMP 5, and overall industry QA standards. This role acts as a key bridge between software development teams and pharma quality teams to ensure the product is compliant, validated, and audit-ready.Key Responsibilities- Review...
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Executive Assistant
2 weeks ago
Bhavnagar, India Jobted IN C2 Full timePosition Executive Assistant to CEO Qualificaiton Any Graduate Experience 3-5 yrs Joining Immediately Job Locaiton Changodar Ahmedabad Industry Pharma company Salary upto 45 K p m Objective To provide high-level administrative and operational support to the Managing Director MD or CEO ensuring effective coordination communication and execution of business...
