Global Regulatory Affairs Solution Lead
3 weeks ago
Job Overview Our organization is seeking a seasoned professional to serve as a consultant and advisor, offering expert guidance to enhance complex global business processes, products, and services. The successful candidate will lead both the strategic and operational implementation of Veeva Vault capabilities in the Regulatory area. Key Responsibilities Project Leadership & Planning: Develop and manage detailed project plans, ensuring alignment with overall program timelines and objectives. Testing & Quality Assurance: Design and implement comprehensive test strategies, automate test cases (e.g., using TOSCA), and ensure compliance with regulatory standards. Oversee test execution, defect tracking, and periodic regression releases. Data Migration & Integrity: Lead data migration activities, including data cleansing, transformation, validation, and post-migration quality checks to ensure accuracy and completeness. Required Skills and Qualifications Expertise in data management, data modeling, and data analysis. Strong understanding of GxP, CSV, and regulatory standards. Ability to design and implement effective testing and quality assurance strategies. Excellent leadership and communication skills. Desirable Requirements: 12+ years of IT experience, preferably in cutover, testing, and migration. Specialized expertise in regulatory affairs, data management, and quality assurance.
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Regulatory Affairs IT Architect
4 weeks ago
Hyderabad, India beBeeTechnical Full timeSenior Technical Solution Specialist Create innovative IT solutions and services to meet quality and performance requirements and technical constraints. About the Role This position requires a consultant and advisor to improve complex global business processes, products, and services in Regulatory Affairs. Lead technical activities for transformative...
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Regulatory Affairs Manager
2 weeks ago
Hyderabad, Telangana, India Amgen Inc Full time ₹ 1,20,000 - ₹ 2,40,000 per yearJob Summary: Amgen is seeking a Manager, Regulatory Affairs CMC Data Automation to shape the future of regulatory affairs by driving digital transformation and automation within CMC submissions. At Amgen, we are committed to innovation and excellence in regulatory science, offering a dynamic work environment where expertise in automation and AI can make a...
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Regulatory Affairs Associate Director
2 weeks ago
Hyderabad, Telangana, India Amgen Inc Full time ₹ 20,00,000 - ₹ 25,00,000 per yearRole description:Amgen is seeking a Regulatory Affairs Associate Director supporting lifecycle management for approved, mature products across all Amgen Therapeutic Areas. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and life cycle management of all Amgen molecules. In this...
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Executive Regulatory Affairs
7 days ago
Hyderabad, Telangana, India Jodas Expoim Full time ₹ 5,00,000 - ₹ 12,00,000 per yearJob Title: Regulatory Affairs ExecutiveDepartment: Regulatory AffairsLocation: HyderabadExperience: 1-5 YearsIndustry: Pharmaceuticals (Injectables / OSD)About Jodas ExpoimJodas Expoim is a fast-growing, global pharmaceutical company committed to delivering high-quality, affordable medicines. We focus on complex injectables and are driven by innovation,...
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Regulatory Affairs Specialist
5 days ago
Hyderabad, India Dr. Reddy's Laboratories Full timeJob Summary We are seeking a detail-oriented Specialist in Regulatory Affairs primarily focusing on Oligonucleotides typically has a role that involves ensuring compliance with regulatory requirements for these products. Responsibilities include managing chemistry, manufacturing, and controls (CMC) documentation for DMF submission, addressing deficiency...
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Regulatory Affairs Manager
2 weeks ago
Hyderabad, Telangana, India Amgen Technology Private Limited Full time ₹ 40,00,000 - ₹ 1,20,00,000 per yearRegulatory Affairs Manager (CMC) Career CategoryInformation Systems Job Description The RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of...
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Regulatory Affairs Specialist
2 weeks ago
Hyderabad, Telangana, India Medtronic Full time ₹ 5,00,000 - ₹ 12,00,000 per yearAt Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the LifeRegulatory Affairs Specialist In this exciting role as a Regulatory Affair Specialist, you will...
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Hyderabad, India ArtiXio Full timeAbout the Role We are looking for a Regulatory Affairs Lead/ Project Manager to join our dynamic team. The ideal candidate is a passionate regulatory professional with hands-on experience in preparing and submitting applications to Health Authorities in Asia, LATAM, or other international markets. This role requires strong leadership, high attention to...
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Senior Regulatory Affairs Specialist
3 days ago
Hyderabad, Telangana, India Dyaz Innovate Full time ₹ 8,00,000 - ₹ 24,00,000 per yearCompany DescriptionDyaz Innovate is a software company with its flagship product, DyazRIMS, which supports the entire regulatory compliance process. The company is committed to enhancing regulatory processes for clients globally and promotes an engaging and supportive work environment.Role DescriptionThis is a full-timeon-siterole for a Senior Regulatory...
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Hyderabad, India Dr. Reddy's Laboratories Full timeJob SummaryWe are seeking a detail-oriented Specialist in Regulatory Affairs primarily focusing on Oligonucleotides typically has a role that involves ensuring compliance with regulatory requirements for these products. Responsibilities include managing chemistry, manufacturing, and controls (CMC) documentation for DMF submission, addressing deficiency...