▷ (15h Left) DRC Specialist
2 days ago
Job Description Role- DRC Specialist This position is responsible for effective operational and regulatory support to Sandoz as well as to regional/global organizations for assigned regulatory submission and maintenance activities, including preparation and submission of regulatory dossiers, maintenance of regulatory databases and archives and artwork-related activities. Job Description Your Key Responsibilities: Your responsibilities include, but not limited to: - Is responsible for implementing regulatory strategy and managing operational activities for assigned medium regions. Provides input into global regulatory strategy and contributes to Regulatory Functional Plan (RFP) and Seed Document, or their equivalents, including identification of gaps or risks in global strategic plan for assigned regions. - Partners with regions to align on regulatory strategy in order to fulfil business objectives. Implements RFP across assigned regions. 1/3. Determines requirements and sets objectives for Health Authority (HA) interactions with DRA GPT representative and/or GTAL. - Facilitates preparation and finalization of briefing books and contributes to preparation of summary documents. Develops and implements plans for timely response to HA requests and coordinates responses. - May serve as local HA liaison depending on location (e.g., FDA or EMA). Drives coordination, planning, and submission of dossiers in assigned regions worldwide. Review of global dossier summary documents. Develops and implements plans to avoid/minimize clock stops during submission review. - Reviews, approves and submits Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs). Reviews and submits Risk Management Plans. May lead negotiations for regional approvals independently or with DRA GPT representative and/or GTAL. - Responsible for facilitating timely submission and approval of dossier with HAs under the guidance of the DRA GPT representative and/or GTAL. Erroneous decisions result in critical delays and modifications to projects or operations; cause substantial expenditure of additional time, human resources, and funds; and jeopardize future business activity. Contributes to and often leads the development of departmental goals and objectives. What you ll bring to the role: Essential Requirements: - Minimum 5+ years of experience in Regulatory Affairs - Produces high quality strategic project documentation and presentations; no late changes in strategy due to inadequate prior evaluation. - No delays in approvals of clinical studies, global registration dossiers or variations due to late or inadequate submission documentation on matters within RA CMC control. - Delivers reliable, timely and accurate information / communication about project specific issues within own department and to key stakeholders -RA CMC regulatory documentation follows Sandoz guidelines and meets regulatory guidelines. - Provides high quality regulatory evaluation and strategic advice on time (change control, etc.); regulatory compliance met in all compliance systems. - Maintains collaborative partnerships with stakeholders
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▷ 15h Left: sourcing specialist
2 weeks ago
hyderabad, India Randstad Full timeSourcing Specialist about randstad enterpriseAs the leading global talent solutions provider, Randstad Enterprise enables companies to create sustainable business value andagility by keeping people at the heart of their organizations. Part of Randstad N.V., we combine unmatched talent data and marketinsights with smart technologies and deep people expertise....
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▷ 15h Left: Business Development Specialist
3 weeks ago
Hyderabad, India Farsight Technologies Full timeJob Code: CETE/0026: Business Development Specialist Experience: 2–5 Years Location: Hyderabad, Telangana (Work from Office) CTC Range: ₹6 LPA – ₹10 LPA (based on experience & performance) 💼 About the Role Farsight Technologies is expanding its SaaS business and we’re looking for a Business Development Specialist who can drive growth through...
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Senior Physical Design Engineer
4 weeks ago
Hyderabad, India MosChip® Full timeResponsibilities: Top-level floor planning, PG Planning, partitioning, placement, scan-chain-reordering, clock tree synthesis, timing optimization, SI aware routing, timing analysis/closure, and ECO tasks (timing and functional ECOs), SI closure, design rule checks (DRC), and Logical vs. Schematic (LVS) checks, Antenna checks. Worked on 65nm or lower node...
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Hyderabad, India PeopleLink Unified Communications Pvt Ltd Full timeThis is a remote position Hi Do you have good knowledge on Shopify and Amazon USA If yes Apply for Freelance Part time eCommerce Specialist and work from your home About Us PeopleLink is a leading Audio Video Collaborations Solution provider company You can visit us at for more details Role Overview As a Freelance eCommerce Specialist you will be responsible...
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Hyderabad, India Credgenics Full timeThe Information Technology Specialist is responsible for overseeing the design, implementation, security, and maintenance of an organization's network infrastructure. This role ensures optimal performance, reliability, and security of all network systems while leading a team of IT professionals. The ideal candidate possesses strong leadership,...
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▷ 15h Left! Senior It Recruiter
3 weeks ago
Hyderabad, India Allegis Global Solutions Full timeYour Role Reporting into the Business Manager or Senior Business Manager, you will assist in driving best practice across the recruitment lifecycle and strive to be an ambassador for the Allegis Global Solutions brand at every interaction. This is an individual contributor role. The key focus for the Senior Recruitment Relationship Manager is to lead the...
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▷ 15h Left! Motion Graphic Designer T2
2 weeks ago
Hyderabad, India McDonald's Full timeAbout McDonald's: One of the world's largest employers with locations in more than 100 countries, McDonald's Corporation has corporate opportunities in Hyderabad. Our global offices serve as dynamic innovation and operations hubs, designed to expand McDonald's global talent base and in-house expertise. Our new office in Hyderabad will bring together...
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▷ 15h Left! Specialist
1 week ago
Hyderabad, India TP Full timeMarket segmentation and target profiling. Mapping the SME buyer journey. Creating sales scripts and pitch decks. Implementing CRM workflows and automation. Conducting training sessions for sales representatives. Monitoring KPIs such as lead-to-sale ratio, average deal size, and customer lifetime value. Expected Outcomes: Increased sales efficiency and...
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(15h Left) Zoho Developer
3 weeks ago
Hyderabad, India Learnall - Zoho Premium Partner Full timeCompany Description With a stellar 8-year legacy as a Zoho Partner, Learnall stands as a pioneer in crafting tailored and comprehensive solutions for clients. Our expertise extends across a diverse spectrum of Zoho Projects, including Zoho Books, CRM, Analytics, and other pivotal products. We bring a strategic edge to every project, ensuring seamless...
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▷ 3 Days Left! Layout/Mask designer
2 weeks ago
Hyderabad, India SysTechCorp Inc Full timeJobTitle : Layout/Mask Designer 3_INR Location : Bangalore Role and Responsibilities: • Responsible for Design and development of critical analog, mixed-signal, custom digital block and full chip level integration support. • Perform layout verification like LVS/DRC/Antenna, quality check and documentation. • Responsible for on-time delivery of...
