
Regulatory Affairs IT Architect
1 day ago
Senior 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 solutions that bring competitive advantages. Responsibilities: Develop architectural solutions for Regulatory Affairs. Utilize architecture patterns to suggest optimal technical platform utilization. Ensure designs adhere to architectural roadmap and support software/service development, execution, and operations. Engage internal and vendor project teams to explain proposed Architecture. Maintain and evolve Architecture tools and platforms, principles, policies, and standards. Ensure user experience is considered when designing new solutions and services. Provide input to project proposals related to new technologies/innovations. Liaise with vendors and Novartis internal IT teams to ensure accurate interpretation and implementation of technical requirements. Requirements: Multi-national global experience in interacting with senior management. Experience in Regulatory Affairs business processes is a plus. Bachelor's degree in engineering or pharmaceutical discipline. Advanced degree (MBA, MS) and related accreditations are desirable. 12+ years of IT solution architecting experience with excellent communication skills. Key Skills: Budget Management, Business Acumen, Influencing Skills, Performance Management, Risk Management, Service Delivery Management, Strategic Planning, Waterfall Model
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Regulatory Affairs
4 weeks ago
Hyderabad, India Clininfotech Full timeWe are seeking a Regulatory Affairs Executive Freshers To Work in the MNC For Hyderabad LocationThe ideal candidate should have hands-on experience in compiling and reviewing ACTD and CTD dossiers for various regulatory submissions. Required Candidate profile B.Pharm & M.Pharm With Knowledge of Regulatory Affairs CTD ECTD DMF and Regulatory Guidelines are...
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Regulatory Affairs
2 weeks ago
Hyderabad, India LEE PHARMA LTD Full timeManaging regulatory affairs of the organization its subsidiaries/associates Liaising with regulatory bodies like State and Central FDA,DCI Well conversant with Drug law/feed supplement regulation Co-ordination with purchase, marketing departments Preparation of Applicant part and Restricted part DMFs (USDMF, EUDMF and ROW). **Salary**: From ₹171,172.50...
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Executive Regulatory Affairs
1 day 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 Manager
7 days 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
4 days ago
Hyderabad, India Cellix Bio Full timeHere, everyone matters and you will be a vital contributor to our inspiring, bold mission. You will help make an impact on people’s lives and change futures every day. We are equally committed to bringing out your best and fostering a collaborative workplace built on trust and respect. We empower our people to take charge of their potential. We offer...
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Regulatory Affairs Manager
2 weeks ago
Hyderabad, Telangana, India Revio Therapeutics Full time ₹ 12,00,000 - ₹ 24,00,000 per yearRole DescriptionRevio Therapeutics is seeking a seasoned Regulatory Affairs Manager with 10–15 years of experience to oversee all regulatory activities across development and registration of our 505(b)(2)/Hybrid programs. This role requires deep understanding of US FDA regulations, guidances as well as for other regulated markets. The candidate should have...
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Regulatory Affairs Manager
1 week 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 _ US Market
4 weeks ago
Hyderabad, India BVR People Consulting Full timeGreetings We are seeking experienced professionals in Regulatory Affairs US Market (CMC, Module 3) with expertise in Formulation, for our Hyderabad-based R&D Centre. Regulatory Affairs US Market (CMC) with strong exposure to ANDA/NDA submissions and post-approval changes. Key Responsibilities: Hands-on experience in US Regulatory Affairs for ANDA & NDA...
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Regulatory Affairs _ US Market
5 days ago
Hyderabad, Telangana, India BVR People Consulting Full time ₹ 9,00,000 - ₹ 12,00,000 per yearGreetingsWe are seeking experienced professionals in Regulatory Affairs US Market (CMC, Module 3) with expertise in Formulation, for our Hyderabad-based R&D Centre.Regulatory Affairs US Market (CMC) with strong exposure to ANDA/NDA submissions and post-approval changes.Key Responsibilities:Hands-on experience in US Regulatory Affairs for ANDA & NDA (Approved...
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Regulatory Affairs Assistant
2 weeks ago
Hyderabad, India Gamut HR Solutions Full timeCompany Overview Gamut HR Solutions, headquartered in Hyderabad, is dedicated to connecting individuals with the right jobs. With a tight-knit team of 2-10 employees, our focus is on providing personalized employment solutions. Discover more about us at . Job Overview We are seeking a Mid-Level Regulatory Affairs Assistant to join our team full-time in...