
Regulatory Affairs Manager
3 days ago
Key Responsibilities:Dossier Preparation & Review: o Prepare and review CTD/eCTD/non-CTD dossiers for new product registrations, renewals, and variations for RoW markets (e.g., Africa, Southeast Asia, CIS, LATAM).Ensure dossiers are in line with current regulatory guidelines and client expectations.Regulatory Submissions & Approvals: o Coordinate with agents for regulatory submission and queries.Track and manage timelines for submissions and approvals to ensure compliance with project milestones.Regulatory Intelligence & Compliance: o Monitor changes in regulatory guidelines and keep relevant stakeholders informed.Ensure all submissions and regulatory strategies align with applicable national and international regulations.Lifecycle Management: o Manage regulatory documentation for product variations, renewals, packaging/labelling updates, and post-approval changes.Audit & Documentation: o Maintain and update regulatory databases and trackers.
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Regulatory Affairs Specialist
2 weeks ago
Ahmedabad, Gujarat, India Frisch Medical Devices PVT LTD Full timeJob Title: Regulatory Affairs Junior ManagerLocation: At Ahmedabad Office , Near Thaltej Crossroads Department: RA Reports To: RA Head and Regulatory Department at HO /Director Employment Type: Full TimeOffice hours : 9,30 AM to 6 PMWeek of: Sunday and Saturday Half Day Preferred Gender : M/FExperience: Minimum 2 years Job Summary:We are seeking a...
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Regulatory Affairs Specialist
1 day ago
Ahmedabad, Gujarat, India beBeeRegulatoryAffairs Full time ₹ 5,00,000 - ₹ 10,00,000Regulatory Affairs Team Member Job DescriptionAbout the RoleWe are seeking a highly skilled Regulatory Affairs team member to join our project teams. As a key member of the team, you will play a critical role in ensuring compliance with regulatory requirements and contributing to the success of our projects.Key ResponsibilitiesRegulatory Project Plan...
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Senior Manager Regulatory Affairs
3 days ago
Ahmedabad, Gujarat, India United HR Solutions Pvt. Ltd. Full timeDesignation: Regulatory Affairs ManagerIndustry: Medical Devices (Orthopedic devices preferred)Experience required: 10 to 15 YearsLocation: Sanand, AhmedabadCompany overview:A globally‑recognized orthopedic medical device firm founded in 2003, delivering cutting-edge sports‑medicine and extremities implants and instruments across six continentsDriven by...
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Regulatory Affairs Director
17 hours ago
Ahmedabad, Gujarat, India beBeeRegulatory Full time ₹ 30,00,000 - ₹ 40,00,000Job Title: Senior Manager Regulatory AffairsAbout the Role:We are seeking a seasoned senior manager to lead our regulatory affairs team and spearhead compliance strategy for global markets.Key Responsibilities:Compliance Strategy Development: Develop and implement comprehensive regulatory compliance strategies tailored to meet global market...
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Regulatory Affairs Specialist
1 day ago
Ahmedabad, Gujarat, India beBeeRegulatory Full time ₹ 9,00,000 - ₹ 12,00,000Regulatory Affairs Professional">Job Description:As a key member of the regulatory team, you will be responsible for ensuring the timely submission of high-quality regulatory documents and providing strategic guidance to team members.You will interact with various stakeholders across functions including Compliance, Marketing, R&D, Engineering, Manufacturing,...
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Senior Manager Regulatory Affairs
4 days ago
Ahmedabad, Gujarat, India United HR Solutions Pvt. Ltd. Full timeDesignation: Regulatory Affairs Manager Industry: Medical Devices (Orthopedic devices preferred) Experience required: 10 to 15 Years Location: Sanand, Ahmedabad Company overview: A globally‑recognized orthopedic medical device firm founded in 2003, delivering cutting-edge sports‑medicine and extremities implants and instruments across six...
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Senior Manager Regulatory Affairs
3 days ago
Ahmedabad, Gujarat, India beBeeRegulatoryAffairsManager Full time ₹ 9,00,000 - ₹ 12,00,000Key Responsibilities:\Develop Regulatory Strategy: Design, implement, and maintain a comprehensive regulatory compliance strategy to meet global market requirements for products.\Ensure Alignment with Business Goals: Develop and execute plans to align the company's overall business strategy with regulatory objectives.\Lead Global Regulatory Planning:...
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Assistant Regulatory Affairs Manager
4 days ago
Ahmedabad, Gujarat, India Octavius Pharma Pvt. Ltd. Full timeCompany brief Since 1980, Octavius Pharma has been empowering lives through its high quality technologically driven diverse range of products. Over the years, Octavius has expanded its product portfolio & operations in different market segments worldwide. As a global leader in pharmaceutical products and direct compressible granules, we develop products at...
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Regulatory Compliance Manager
2 days ago
Ahmedabad, Gujarat, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 25,00,000Senior Regulatory Affairs SpecialistAbout the Role:We are seeking a Senior Regulatory Affairs Specialist to join our team. In this role, you will be responsible for leading and managing regulatory activities for USFDA submissions, including ANDA preparation, review, and filing.Key Responsibilities:Manage regulatory activities for USFDA submissions, including...
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Regulatory Affairs Manager
2 weeks ago
Ahmedabad, Gujarat, India Red Envelope Consultants Full timeKey Responsibilities:Dossier Preparation & Review: o Prepare and review CTD/eCTD/non-CTD dossiers for new product registrations, renewals, and variations for RoW markets (e.g., Africa, Southeast Asia, CIS, LATAM).Ensure dossiers are in line with current regulatory guidelines and client expectations.Regulatory Submissions & Approvals: o Coordinate with agents...