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7.0 - 11.0 years

0 Lacs

coimbatore, tamil nadu

On-site

In this role, you will be responsible for preparing, reviewing, and finalizing detailed cost estimates for prefab construction projects and tenders. You will need to conduct comprehensive pre- and post-tender document checks to ensure accuracy and compliance. Additionally, you will be required to perform detailed rate analysis for all project components and maintain an up-to-date rate library. Your responsibilities will also include compiling and submitting final costing sets for tenders and projects within stipulated deadlines. It will be crucial for you to ensure that all estimation documents are complete, accurate, and aligned with project requirements. You will need to communicate costing details and key insights to top management for informed decision-making. Furthermore, you will interact with clients to clarify project requirements and provide tailored costing solutions. Coordination with cross-functional teams such as engineering, procurement, and execution for data gathering and validation will also be a key aspect of your role. As a team leader, you will lead and manage the costing team, assigning tasks and ensuring effective workflow. You will also be responsible for mentoring and developing team members to enhance estimation accuracy and efficiency. Qualifications: - Education: Bachelors degree in Civil Engineering, Construction Management, or related field. - Experience: 7+ years in estimation for prefab or modular construction projects. - Technical Skills: Proficiency in estimation software (e.g., Candy, CostX, MS Excel), strong analytical and numerical skills. - Soft Skills: Excellent leadership, communication, and client interaction abilities; strong attention to detail and organizational skills. Reporting Structure: - Reports to: Head of Engineering / Tendering. - Collaborates With: Project Management, Engineering, Procurement, and Client Teams Please note that this is a permanent position and the work location is in person.,

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0.0 - 2.0 years

2 - 4 Lacs

bengaluru

Work from Office

Role & Responsibilities: Ensure compliance with applicable laws, regulations, and guidelines related to the company's products or services. Regulatory Submissions: Prepare, review, and submit regulatory documents to relevant authorities, such as product registrations, notifications. Documentation Management: Maintain accurate and up-to-date regulatory documentation, including product technical files, labeling, and manufacturing records. Collaborate with cross-functional teams to provide regulatory guidance and support during product development stages. Review product specifications and documentation to ensure compliance. Regulatory Liaison: Communicate and interact with regulatory authorities or third-party consultants to address inquiries, resolve issues, or obtain necessary approvals. Regulatory Audits: Assist in preparing for and participating in regulatory audits or inspections. Address any findings or observations and implement corrective actions. Quality Assurance: Participate in quality assurance activities, including conducting internal audits, implementing corrective and preventive actions, and ensuring compliance with quality standards. Risk Management: Assess and mitigate regulatory risks associated with product compliance, labeling, advertising, or post-market surveillance. Cross-functional Collaboration: Collaborate with various departments, such as QA,QC R&D, and marketing, to ensure alignment with regulatory requirements. Regulatory Reporting: Prepare periodic reports on regulatory activities, metrics, or performance indicators for management or regulatory authorities.

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4.0 - 6.0 years

3 - 3 Lacs

kolkata

Work from Office

We are looking for a detail-oriented and proactive Admin Assistant to join our team in Kolkata. The ideal candidate should have strong administrative skills with hands-on experience in handling government tenders and e-marketing portals

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5.0 - 10.0 years

0 - 0 Lacs

pune

Work from Office

We are seeking great talent to help us build The DNA of tech.® Vishay manufactures one of the world's largest portfolios of discrete semiconductors and passive electronic components that are essential to innovative designs in the automotive, industrial, computing, consumer, telecommunications, military, aerospace, and medical markets. We help the world's most in-demand technologies come to life. Every day our products touch your life and the lives of people across the world, though you likely do not know it. Come join us and help us build The DNA of tech.™ Vishay Intertechnology, Inc. is a Fortune 1,000 Company listed on the NYSE (VSH). Learn more at www.Vishay.com. Do you want to help us build the DNA of tech.? Vishay INDIA is currently seeking applicants for Senior Product Compliance Officer responsible for managing all compliance and directive related to product inquiries - REACH, ROHS, IMDS, CDX and BOM CHECK. Job Location: Vishay India (VCIPL) is a wholly owned subsidiary of Vishay Intertechnology Inc, USA. Our state-of-the-art manufacturing unit is in Loni near Pune wherein around 1000 employees are employed. VCIPL has also established a Global IT support center at Magarpatta Cyber City in Pune and Sales offices at Bangalore & Delhi (NCR). What you will be doing: Expertise in product compliance directives/regulations like: ROHS, REACH, PFAS, TSCA, ELV, WEEE, CA Prop 65, POPs, SCIP etc. Expertise in data submission in global product compliance tools like: IMDS, CAMDS, CDX and BOMCHECK. Strong understanding of electronic components (Active, Passive commodities). Interpret and examine customer environmental compliance request on Vishay product portfolio. Distribute customer queries to impacted divisions. Keep track record of all requests and queries. Window contact for customer request and queries. Maintain Online Credentials for Vishay on Customer Website Provide regular updates across Vishay. Should have hands on experience in handling Product Compliance requirements. Good to have hands on experience in handling iPoint software Good to have expertise in Microsoft Excel. Coaching/Guiding other team members on product compliance related topics. What you will bring along: BE/B.Tech in Electronics/Electrical/Chemical/Mechanical or M.Sc. Environmental Science 5 to 7 years relevant experience Excellent coordination and communication skills. Knowledge of Electronic Components Problem-solving skills and the ability to handle pressure. Conversant to work on Microsoft Office. What can we offer you for your talent Vishay offers a comprehensive suite of benefit programs including health care coverage and provides you with resources to help you achieve your personal and professional goals. With us, you'll experience unique career paths, an open and collaborative culture, a stable business that will be there for you, and opportunities to work globally and locally. **Non-Discrimination and Harassment: Vishay is committed to a workplace free of harassment and unlawful discrimination. We do not engage in discrimination or harassment based on race, color, age, gender, sexual orientation, gender identity and expression, ethnicity or national origin, disability, pregnancy, religion, political affiliation, union membership, covered veteran status, protected genetic information or marital status in hiring and employment practices.

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5.0 - 10.0 years

10 - 13 Lacs

bengaluru

Work from Office

Greetings! & very warm welcome to BEST-FIT Recruitment Riders, We are BEST-FIT Recruitment Riders feel immense pleasure to search and provide you with better carrier opportunities to aid you in achieving your aspirations. BEST-FIT Recruitment Rider is a Trusted Emerging Recruitment & Executive Search Partner for Pharmaceutical, Biotech, CRO, Chemicals, Medical Devices & Turnkey Pharma Projects Engineering-Construction Design Sectors. We are searching & recruiting highly qualified professionals for Middle-Senior-Upper-Management and Executive jobs. (Eg: Managers, VP, President, CFO & CEO). Also offering customized recruitment services by Headhunting & Executive Search for Middle & Top management level professionals according to clients specific needs. We are BEST-FIT Recruitment Riders do exactly what our name tells. To know more about us please visit our website: www.bestfitrecruitment.co.in We would like to inform you that presently we have professional career opportunity matching to your profile with one of our esteemed client. Please see the following position summary: Client Name: Australian Global Pharma specialist in Pharmaceutical & Medical Device Position: Assistant Manager - Regulatory Affairs Markets: UK & Europe Products: Solid Oral, Injectable, Topical Location: Bangalore Job Profile: Regulatory Strategy & Planning: Support the development and execution of regulatory strategies for product registration and lifecycle management in the UK market. Assist in regulatory risk assessment and provide input during product development, launch, and post-marketing phases. Stay updated with MHRA and EU regulatory requirements, and ensure integration into company processes. Dossier Preparation & Submission: Prepare, review, and submit high-quality regulatory dossiers including 1. Marketing Authorization Applications (MAA) 2. Post-approval variations (Type IA/IB/II) 3. Renewals 4. Line extensions 5. Clinical Trial Applications (if applicable) 6. Responses to regulatory queries and deficiency letters 7. Compile and maintain product documentation in eCTD, NeeS, or paper format (as required). 8. Coordinate with global teams to obtain required documentation for submission. Product Lifecycle Management: Maintain Marketing Authorisations (MAs) for assigned products in the UK. Ensure that labeling, artwork, and product information (SmPC, PIL, and labels) are compliant with current UK/EU legislation. Monitor timelines and ensure timely submission of periodic safety update reports (PSURs) and risk management plans (RMPs), as applicable. Regulatory Communication: Act as a liaison with the MHRA and other regulatory bodies to facilitate the approval and maintenance of products. Respond to questions and requests from health authorities efficiently and professionally. Cross-functional Collaboration: Work closely with cross-functional teams including R&D, QA, Manufacturing, Supply Chain, Pharmacovigilance, and Medical Affairs. Ensure consistent regulatory input during formulation, scale-up, process validation, and batch release. Regulatory Intelligence & Compliance: Monitor changes in the UK and EU regulatory environment (including post-Brexit developments). Interpret and communicate regulatory updates to internal stakeholders. Ensure regulatory processes are compliant with internal SOPs and global regulatory standards (EMA, ICH, MHRA). Desired Profile: B.Pharm / M.Pharm / M.Sc with 5 to 10 yrs experience in Regulatory Affairs with Pharmaceutical company preferably focused on the UK / EU markets. Experience & knowledge in the preparation of major regulatory submissions & supportive amendments or supplements. Must have exposure in UK or EU. Experience with MHRA submissions is a must. Knowledge of post-Brexit regulatory landscape, including the separation of EU and UK procedure. Proficient in preparing & compiling eCTD/NeeS format dossiers using publishing tools (e.g., Extedo, Lorenz). Strong knowledge of SmPC, PIL, and labeling requirements under UK and EU laws. Familiarity with Common Technical Document (CTD) structure & ICH guidelines. Experience with generic, branded, or biologic drug submissions. Exposure to CP (Centralised Procedure), MRP (Mutual Recognition Procedure), & DCP (Decentralised Procedure) is a plus. Working knowledge of Quality Management Systems (QMS) & pharmacovigilance frameworks. Certification or training in regulatory affairs (e.g., from RAPS or TOPRA). Excellent communication & interpersonal skills. Strong analytical & problem-solving abilities. Meticulous attention to detail. Ability to manage multiple priorities and work under pressure. Recruiter Details: BEST - FIT Recruitment Riders G-7, Amrit Complex, Opp: Mahavir Jain Vidhyalaya & Jain Derasar, R.V. Desai Road, Near Goyagate Circle, Vadodara-390001, Gujarat, India Mobile: 09722052906, 09722042906 E-Mail: career@bfrr.in Website: www.bestfitrecruitment.co.in

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7.0 - 11.0 years

8 - 12 Lacs

pune

Work from Office

Job Description Pharma Regulatory Affairs Manager Location: Pune, Maharashtra Department: Regulatory Affairs Reports To: Head – Regulatory Affairs / Senior Leadership Job Overview We are seeking a highly skilled and experienced Pharma Regulatory Affairs Manager to ensure compliance with global regulatory requirements and to support the successful development, approval, and commercialization of pharmaceutical products. The ideal candidate will bring deep expertise in regulatory affairs, strong leadership in navigating complex regulatory landscapes, and the ability to collaborate effectively with internal teams and regulatory authorities. Key Responsibilities Develop and implement regulatory strategies to ensure compliance with international and regional regulations . Prepare, review, and submit regulatory documents in line with global requirements (US, EU, and emerging markets). Liaise with regulatory authorities to address queries and obtain timely approvals. Monitor evolving regulatory guidelines and industry trends , assessing their impact on product development and commercialization. Partner with R&D, Quality, Clinical, and Legal teams to provide regulatory insights throughout the product lifecycle. Support documentation for clinical trials , including protocols, investigator brochures, and informed consent forms. Conduct risk assessments and provide recommendations for safety reporting and compliance obligations. Participate in audits and inspections , driving corrective and preventive actions as needed. Provide regulatory training and guidance to internal stakeholders to enhance compliance awareness. Qualifications & Requirements Education: Bachelor’s degree in Pharmacy or a related scientific field (Master’s preferred). Experience: 7 - 8 years in pharmaceutical regulatory affairs within a global organization. Strong knowledge of FDA regulations (21 CFR Part 11), ICH guidelines, EMA, and regional market requirements . Demonstrated success in regulatory submissions leading to product approvals. Proven project management skills , with the ability to manage multiple projects in a dynamic environment. Excellent written and verbal communication skills for engaging internal teams and external authorities. Strong analytical, problem-solving, and decision-making abilities. Proficiency in regulatory information management systems and related tools.

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6.0 - 10.0 years

4 - 15 Lacs

vadodara

Work from Office

Compilation and submission of eCTD dossier for new product (Finished) application & post approval submission Query response, PAS,CBE and annual report, drug listing Review of artwork and submission of labelling section Maintain product life cycle.

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3.0 - 6.0 years

1 - 5 Lacs

bengaluru

Work from Office

Unlock Your Potential in the UK P&C Insurance Domain at ReSource Pro India! Join Our Dynamic Team at ReSource Pro India! Are you ready to elevate your career in the UK Property and Casualty (UK P&C) Insurance sector? We're on the hunt for passionate professionals with the following expertise: Experience Required: 3 - 6 years Core Expertise: Experienced in UK Specialty Insurance and Reinsurance and deep understanding of UK-specific terms: 1. Reinsurance structures (including treaty, lineslip, quota share, etc.) 2. Specialty lines knowledge (e.g., marine, finance, professions, etc.) Soft Skills: 1. Analytical skills and Good judgment ability 2. Detail-oriented: Careful checking to avoid mistakes 3. Fast learner: Can quickly master new knowledge and skills Why Choose Us? Innovative Environment: Be part of a forward-thinking team that values creativity and innovation. Career Growth: Enjoy numerous opportunities for professional development and advancement. Collaborative Culture: Thrive in a supportive and team-oriented workplace. Ready to Make an Impact? If your skills match our needs, wed love to connect with you! Send your resume to Prashanth_Honnachari@Resourcepro.in Seize this opportunity to shape the future of the insurance industry with us! Were excited to welcome you to our team!

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2.0 - 6.0 years

0 Lacs

chennai, tamil nadu

On-site

You will be responsible for preparing Traffic Management Plans and deploying Traffic Marshals. This includes creating Daily Traffic Reports and liaising with the Client to address any Traffic Management Issues. You will also need to submit Monthly/Quarterly Traffic Management Plans. Additionally, you will be coordinating with internal departments to schedule work and ensure proper traffic management. It is essential to understand the L&T Heavy Civil Infrastructure IC EHS Integrated Management System (IMS) and guarantee its implementation across project operations. You are expected to familiarize yourself with and promote the L&T L.I.F.E. (Live Injury Free Each day) program and Zero Harm Vision. In case of witnessing unsafe practices, you should halt work immediately and advocate for a proactive "Commitment to Action" approach. Furthermore, you will need to advise the Project Head on any deficiencies within the EHS IMS, EHS plans, and the execution of the system.,

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10.0 - 15.0 years

15 - 20 Lacs

vadodara

Work from Office

Job description Alembic Pharmaceuticals Ltd is looking for a Regulatory Affairs professional for the position of Manager based at our Corporate Office - Vadodara, Gujarat. Job Criteria: B.Pharm or M.Pharm qualification having experience between 10-15yrs. with dossier submission experience in South East Asia (Malaysia, Philippines, Thailand, Vietnam , Singapore, Lebonon, Hongkong, Brunei and Middle-East (UAE,/soudi,Iraq) Experience of regulatory submissions and life cycle management of SEA and MENA region. Interested candidate can share cv on creyesha.macwan@alembic.co.in

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4.0 - 6.0 years

8 - 10 Lacs

bengaluru

Hybrid

• Develop and review content for various regulatory documents; ensure quality as per setegulatory standards and compliance requirement. • Good understanding of global regulatory dossier formats and ACTD/CTD/NeeS/paper dossier format. • Candidate will need to author and/or review clinical and non-clinical documents under Module 2, 4 and 5 of eCTD, and Part III and Part IV of ACTD for submission to the Health Authorities in EU and APAC markets, respectively. Key requirement: • Good medical/pharma/scientific knowledge that can be applied in developing content for regulatory documents • Experienced in the development and review of clinical and non-clinical documents under Module 2, 4 and 5 of eCTD, and Part III and Part IV of ACTD, for submission to the regulatory authority in EU and APAC regions, respectively • Good understanding of clinical trial and product life cycle EDUCATION: MBBS/PhD/MDS/BDS/MPharm/PharmD/BPharm/MSc EXPERIENCE: 4 to 6 years of Regulatory Writing/Reviewing experience LOCATION: Bangalore (Office-based/Hybrid) SKILLS: • Good communication skills (Written and Oral) • MS Office (Excel and Power point) PRINCIPAL RESPONSIBILITIES & ACCOUNTABILITIES: • Broad Area-1: Develop Content to Meet High CSAT Independently (Simple and Complex Projects) o Responsible for developing new drafts/updating existing content/review with quality, accuracy, timelines, and efforts, independently (Protocol, Informed Consent Form [ICF], Investigators Brochure [IB], clinical and non-clinical documents under Modules 2, 4 and 5 of eCTD and, Part III and IV of ACTD) o Responsible to run and review literature searches in various databases and screening articles to obtain required information for content development o Good knowledge of various regulatory guidelines and regulatory dossiers related to regulatory content development o Conduct quality checks to ensure the accuracy and consistency of data included in documents o Build expertise in extracting information from textbooks, authentic websites and articles for different deliverables and therapeutic areas o Demonstrate good technical competence on how to search the internet and books for referencing, copyrights, and plagiarism o Follow the best practices while executing projects in the team with regard to processes, communication (internal and external), documentation and technical requirements like language, grammar, style, content search, summarizing, data conflicts and referencing o Analyze challenges/limitations in content development and provide logical, unbiased, and rational recommendations for modifying quality standards or introducing newer ones o Work with internal stakeholders for project execution and actively participate in team meetings and client meetings from a content perspective • Broad Area-2: Review Content of Team Members o Review the content prepared by junior team members. Validate the authenticity of the content by performing data fact check o Guide team members on content client requirements and quality aspects of content development for different deliverables development (including but not limited to Protocols, IBs, ICF, clinical and non-clinical documents under Modules 2, 4 and 5 of eCTD and, Part III and IV of ACTD), o Guide team members to develop content outlines for different target groups that are accurate, clinically relevant, reflecting the most recent medical advances and in accordance with established content development practices, in collaboration with clients and team leads • Broad area-3: Process Adherence and Compliance o Be aware of all organizational, divisional, and client-related policies and procedures related to quality, information security and data privacy o Responsible to strictly adhere to quality standards for various deliverables as decided by the business unit or client o Responsible to maintain confidentiality and copyright rules for various deliverables/clients and company norms o Follow all the security rules with regard to various standards like ISMS, ISO, CMMI and client guidelines • Broad Area-4: Self-Development o Support in developing technical training programs for other team members relevant to the job o Responsible to complete client-specific training, if applicable o Responsible to build expertise in assigned deliverables through self-learning and formal trainings and stay abreast with current trends in the respective areas o Learn the basic skills to manage teams o Participate in and contribute to various continuous improvement initiatives or company driven initiatives Interested Candidate Please Apply - India.hr@infinitysts.com

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0.0 - 2.0 years

5 - 7 Lacs

bengaluru

Work from Office

Overview About Role: We have an exciting role of Junior Editor Analyst to drive and translate creative and contemporary ideas to solid design and impact. You will have a key role in design and deployment of creative campaigns with our global clients, including many Fortune 50 companies. About Omnicom Global Solutions Omnicom Global Solutions (OGS) is an agile innovation hub of Omnicom Group, a leading global marketing and corporate communications company. Guided by the principles of Knowledge, Innovation, and Transformation, OGS is designed to deliver scalable, customized, and contextualized solutions that meet the evolving needs of our Practice Areas within Omnicom. OGS India plays a key role for our group companies and global agencies by providing stellar products, solutions, and services in the areas of Creative Services, Technology, Marketing Science (Data & Analytics), Advanced Analytics, Market Research, Business Support Services, Media Services, and Project Management. We currently have 4000+ awesome colleagues in OGS India who are committed to solving our clients’ pressing business issues. We are growing rapidly and looking for talented professionals like you to be part of this journey. Let us build this, together! Why Omnicom Health (OH) At Omnicom Health, you’re not just starting a job—you’re becoming part of something bigger. As one of the largest and most specialized global healthcare networks, we’re dedicated to building the ideas and solutions of tomorrow. Your career here is about growth, impact, and the chance to shape the future of healthcare. Every day, the work you do will contribute to a greater cause, making a real difference in people’s lives About our Agency Biolumina Biolumina is an oncology-focused, customer-agnostic, curiosity-driven communications agency. Biolumina is a full-service, omnichannel agency delivering customized, data-driven solutions for oncology brands. Our curiosity propels us to uncover truths and discover opportunities through a deep understanding of the science, the disease, and the key stakeholders and their emotional journeys. As a result, we build brand experiences that go beyond the rational to change behaviour and create brand loyalty Know more at: https://www.biolumina.com/who-we-are Responsibilities Ensure that agency submissions to the medical/legal reviewers of our respective clients are accurate by doing the tagging and linking of the references cited in our promotional pieces in each client’s respective online system. Complete any necessary pre-work for FUSE submissions. Develop an in-depth knowledge of submissions platforms (Veeva, FUSE, etc), includes attending periodic training sessions. Attend meetings related to submissions, if necessary. Prioritize and manage multiple tasks independently while meeting deadlines. Project professional, positive attitude toward all Agency members. Uphold Biolumina’s editorial and quality standards in client deliverables. When submissions work is not available, assist with light proofreading tasks under supervision." Qualifications Graduate / Postgraduate

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5.0 - 10.0 years

0 - 0 Lacs

pune

Work from Office

We are seeking great talent to help us build The DNA of tech.® Vishay manufactures one of the world's largest portfolios of discrete semiconductors and passive electronic components that are essential to innovative designs in the automotive, industrial, computing, consumer, telecommunications, military, aerospace, and medical markets. We help the world's most in-demand technologies come to life. Every day our products touch your life and the lives of people across the world, though you likely do not know it. Come join us and help us build The DNA of tech.™ Vishay Intertechnology, Inc. is a Fortune 1,000 Company listed on the NYSE (VSH). Learn more at www.Vishay.com. Do you want to help us build the DNA of tech.? Vishay INDIA is currently seeking applicants for Senior Product Compliance Officer responsible for managing all compliance and directive related to product inquiries - REACH, ROHS, IMDS, CDX and BOM CHECK. Job Location: Vishay India (VCIPL) is a wholly owned subsidiary of Vishay Intertechnology Inc, USA. Our state-of-the-art manufacturing unit is in Loni near Pune wherein around 1000 employees are employed. VCIPL has also established a Global IT support center at Magarpatta Cyber City in Pune and Sales offices at Bangalore & Delhi (NCR). What you will be doing: Expertise in product compliance directives/regulations like: ROHS, REACH, PFAS, TSCA, ELV, WEEE, CA Prop 65, POPs, SCIP etc. Expertise in data submission in global product compliance tools like: IMDS, CAMDS, CDX and BOMCHECK. Strong understanding of electronic components (Active, Passive commodities). Interpret and examine customer environmental compliance request on Vishay product portfolio. Distribute customer queries to impacted divisions. Keep track record of all requests and queries. Window contact for customer request and queries. Maintain Online Credentials for Vishay on Customer Website Provide regular updates across Vishay. Should have hands on experience in handling Product Compliance requirements. Good to have hands on experience in handling iPoint software Good to have expertise in Microsoft Excel. Coaching/Guiding other team members on product compliance related topics. What you will bring along: BE/B.Tech in Electronics/Electrical/Chemical/Mechanical or M.Sc. Environmental Science 5 to 7 years relevant experience Excellent coordination and communication skills. Knowledge of Electronic Components Problem-solving skills and the ability to handle pressure. Conversant to work on Microsoft Office. What can we offer you for your talent Vishay offers a comprehensive suite of benefit programs including health care coverage and provides you with resources to help you achieve your personal and professional goals. With us, you'll experience unique career paths, an open and collaborative culture, a stable business that will be there for you, and opportunities to work globally and locally. **Non-Discrimination and Harassment: Vishay is committed to a workplace free of harassment and unlawful discrimination. We do not engage in discrimination or harassment based on race, color, age, gender, sexual orientation, gender identity and expression, ethnicity or national origin, disability, pregnancy, religion, political affiliation, union membership, covered veteran status, protected genetic information or marital status in hiring and employment practices.

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4.0 - 8.0 years

0 Lacs

karnataka

On-site

As a Biostatistician at our organization, you will play a crucial role in contributing to cross-functional development teams, aiding in trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions. Your responsibilities will involve collaborating with various team members including the Global Biometric Sciences Biostatistics Lead, medical monitor, protocol manager, data manager, PK scientist, and other study/indication team members. Your role will require you to provide strategic and scientific input at the indication/protocol/integrated analysis level, thereby enhancing the understanding of the asset under study, improving development decisions, and increasing the chances of regulatory and market success. Stakeholder management will be a significant part of your responsibilities, involving interactions with business partners within your team, as well as external vendors, key opinion leaders, and regulatory agencies. You will need to extend your expertise beyond biostatistics by delving into the medical literature and regulatory documents to gain a comprehensive understanding of the clinical, regulatory, and commercial landscape. Additionally, you will contribute to the development strategy to ensure effective and safe utilization of the product. Driving the design of innovative and efficient clinical trials, selecting study populations, and endpoints, and translating scientific questions into statistical terms will be among your key tasks. Your role will involve challenging collaborator assumptions based on facts, providing insights, and ensuring that all analyses conducted have clearly articulated hypotheses associated with them. Effective communication with clinical and regulatory partners, as well as external opinion leaders, will be essential. You will also be responsible for authoring and/or reviewing various study-level documents such as protocol synopsis, statistical analysis plan, clinical study reports, and publications. Compliance with organizational processes and standards, ensuring quality deliverables, and collaborating with clinicians and medical writers to prepare summaries of results will be part of your routine tasks. You will lead the development and execution of statistical aspects for multiple or complex studies independently, as well as play a crucial role in filing activities and defending protocols and Statistical Analysis Plans (SAPs) at reviews. To excel in this role, you must keep abreast of state-of-the-art applied statistical methodology, understand CDISC standards and implementation guides, and ensure quality in all planning, design, and execution of assignments associated with the assigned protocol or project. Your ability to drive alignment at the study team level and provide statistical consultation for ad hoc analysis requests will be key to your success in this position.,

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1.0 - 5.0 years

0 Lacs

jaipur, rajasthan

On-site

As a Document Collection Executive, your primary responsibility will be to visit clients for document collection, submission, or obtaining signatures on required forms. You will be tasked with handling loan-related documentation, which includes checking, collecting, and organizing KYC documents, income proofs, agreements, and other necessary paperwork. It is crucial to ensure that all documents are complete, accurate, and compliant with both company and bank requirements. Your role will also require you to maintain a proper digital filing system for all documentation and ensure timely submission and retrieval of documents as per set deadlines. To excel in this role, you must possess a bike with a valid driving license as you will be required to travel within the city for client visits. While prior knowledge of loan documents and the KYC process is preferred, individuals with basic understanding can also be considered. Strong communication and follow-up skills are essential for effective client interactions. Being punctual, responsible, and organized are key qualities that will contribute to your success in this role. This is a full-time position with a fixed day shift schedule. The work location will involve in-person interactions with clients.,

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3.0 - 5.0 years

4 - 5 Lacs

Gurugram

Hybrid

Job Responsibility - Inspection Ordering: Order property and casualty inspections based on underwriting guidelines. Identify exposures, hazards and any underwriting concern to assist underwriters Assign inspections to appropriate field inspectors or third-party vendors. Track inspection progress and ensure timely completion. Liaise with underwriters, agents, and inspectors to clarify inspection requirements. Maintain accurate records of inspection orders, calculate replacement cost, reports, and follow-ups. Review inspection reports for completeness and escalate discrepancies. Ensure inspections meet regulatory and company standards. Monitor performance and provide feedback for improvement. Assist in developing and updating inspection procedures and workflows. o Ensure complete adherence to defined Service Level Agreements: Productivity Turn-around-time Accuracy Timely maintenance of the various work trackers Qualifications: Experience in property and casualty inspection coordination. Strong organizational and multitasking skills. Good communication and customer service abilities. Familiarity with insurance underwriting processes and inspection tools. Proficiency in Microsoft Office and insurance management systems. Experience working with third-party inspection vendors. Ability to interpret inspection findings and relay relevant information to underwriting team Preferred candidate profile Understand end-to-end insurance business Analyze and input data into systems / databases Process requests basis various rules (both subjective and objective judgement involved) Operate process and ensure complete adherence to defined Service Level Agreements Uphold Productivity, Turn-around-time, Accuracy Timely maintenance of the various work trackers Analyzes and synthesizes information/makes decisions based on policies Responsible and dedicated to meet the clients expectations Plans tasks and organizes own work Prioritizes tasks in order of importance Keeps the team informed about work-related activities

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2.0 - 3.0 years

3 - 4 Lacs

Gurugram

Work from Office

Job Responsibility - Inspection Ordering under Property & Casuality Insurance Order property and casualty inspections based on underwriting guidelines. Identify exposures, hazards and any underwriting concern to assist underwriters Assign inspections to appropriate field inspectors or third-party vendors. Track inspection progress and ensure timely completion. Liaise with underwriters, agents, and inspectors to clarify inspection requirements. Maintain accurate records of inspection orders, calculate replacement cost, reports, and follow-ups. Review inspection reports for completeness and escalate discrepancies. Ensure inspections meet regulatory and company standards. Monitor performance and provide feedback for improvement. Assist in developing and updating inspection procedures and workflows. o Ensure complete adherence to defined Service Level Agreements: Productivity Turn-around-time Accuracy Timely maintenance of the various work trackers Qualifications: Experience in property and casualty inspection coordination. Strong organizational and multitasking skills. Good communication and customer service abilities. Familiarity with insurance underwriting processes and inspection tools. Proficiency in Microsoft Office and insurance management systems. Experience working with third-party inspection vendors. Ability to interpret inspection findings and relay relevant information to underwriting team. Job - Inspection Ordering under Property & Casuality Insurance Understand end-to-end insurance business Analyze and input data into systems / databases Process requests basis various rules (both subjective and objective judgement involved) • Operate process and ensure complete adherence to defined Service Level Agreements • Uphold Productivity, Turn-around-time, Accuracy Timely maintenance of the various work trackers Analyzes and synthesizes information/makes decisions based on policies Responsible and dedicated to meet the clients expectations Plans tasks and organizes own work Prioritizes tasks in order of importance Keeps the team informed about work-related activities

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2.0 - 4.0 years

5 - 7 Lacs

Bengaluru

Work from Office

Overview About Role: We have an exciting role of Submission Specialist to drive and translate creative and contemporary ideas to solid design and impact. You will have a key role in design and deployment of creative campaigns with our global clients, including many Fortune 50 companies. About Omnicom Global Solutions Omnicom Global Solutions (OGS) is an agile innovation hub of Omnicom Group, a leading global marketing and corporate communications company. Guided by the principles of Knowledge, Innovation, and Transformation, OGS is designed to deliver scalable, customized, and contextualized solutions that meet the evolving needs of our Practice Areas within Omnicom. OGS India plays a key role for our group companies and global agencies by providing stellar products, solutions, and services in the areas of Creative Services, Technology, Marketing Science (Data & Analytics), Advanced Analytics, Market Research, Business Support Services, Media Services, and Project Management. We currently have 4000+ awesome colleagues in OGS India who are committed to solving our clients’ pressing business issues. We are growing rapidly and looking for talented professionals like you to be part of this journey. Let us build this, together! Why Omnicom Health (OH) At Omnicom Health, you’re not just starting a job—you’re becoming part of something bigger. As one of the largest and most specialized global healthcare networks, we’re dedicated to building the ideas and solutions of tomorrow. Your career here is about growth, impact, and the chance to shape the future of healthcare. Every day, the work you do will contribute to a greater cause, making a real difference in people’s lives About our Agency Patients & Purpose No One Knows Patients Better. As the health marketing industry’s premier patient agency, patients are at the heart of everything we do. For over 20 years, we’ve been transforming the health consumer experience through digital innovation, data mastery, unparalleled insights, and breakthrough creative, all with the purpose of making patients better. Know more at: https://www.patientsandpurpose.com/ Responsibilities Ensure that agency submissions to the medical/legal reviewers of our respective clients are accurate by completing the tagging and linking of the references cited in our promotional pieces in each client’s respective online system (i.e., Veeva, FUSE) Complete any necessary pre-work required for submissions Develop an in-depth knowledge of submissions platforms (Veeva, FUSE, etc) Demonstrate ability to set priorities while handling multiple projects Project professional, positive attitude toward all Agency members Uphold Agency quality standards in servicing our clients If no submissions work available, may be called upon to do light proofreading under the close supervision of a Managing Editor or Editorial Supervisor Attend meetings related to submissions, if necessary Qualifications Any Graduate/ Postgraduate with 1 to 5 Years of experience

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4.0 - 6.0 years

4 - 6 Lacs

Pune

Work from Office

Aware about PPAP documentation, Process flow diagram, Process control plan, Fabrication , welding, Fluid transmission part, hydraulic tube and pipe, casting and Required Candidate profile Machining parts process awareness. Metallurgy report understanding. MSA, SPC awareness. Daily , weekly and monthly basis report submissions.

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3.0 - 7.0 years

0 Lacs

haryana

On-site

As a Regulatory Affairs Specialist, you will play a crucial role in supporting the product lifecycle through obsolescence. Your responsibilities will include assessing changes made to the device post-launch to determine the regulatory impact of these changes on current clearance. You will ensure regulatory compliance by conducting thorough assessments and submitting the necessary documentation for product clearances and approvals from regulatory bodies such as the FDA and Notified Bodies. In this role, you will support new product development for both domestic and international release by contributing to the development and updating of regulatory strategy based on regulatory changes. You will be seen as a valuable resource within the regulatory team, working with minimum supervision but keeping senior staff informed of your progress. Your tasks will involve developing and applying a basic understanding of regulatory frameworks, requirements, legislation, processes, and procedures. You will manage projects, write reports, coordinate regulatory activities, and execute regulatory assignments that are broad in nature. Additionally, you will assist in the development and review of standard operating procedures (SOPs) and contribute to regulatory strategy updates. You will provide regulatory input for new product development and product lifecycle planning, evaluate the regulatory impact of proposed changes to launched products, and investigate the regulatory history and background related to specific classes, diseases, therapeutics, or diagnostics for regulatory assessment. Your role will also involve determining and communicating submission and approval requirements to relevant stakeholders. To qualify for this position, you must have a Bachelor's or Master's degree in Regulatory Affairs, Engineering, or a related discipline. A minimum of 3-5 years of experience in a similar role within an R&D environment is preferred. Experience with post-market activities and change management will be advantageous, and holding an RAC Certification is also preferred. If you are looking to join a dynamic team where you can leverage your regulatory expertise to drive compliance and contribute to the successful launch of new products, this role may be the perfect fit for you. Apply now and be part of a team that is dedicated to ensuring regulatory excellence and innovation in the medical device industry.,

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0.0 - 1.0 years

1 - 2 Lacs

Pune, Karve Road

Work from Office

Key Responsibilities: Pick up parcels / documents from specified client locations Ensure timely and safe delivery of documents to clients / business locations. Submit visa applications to the relevant embassy or visa processing center as per the guidelines of the seniors Ensure timely and proper submission as per standard procedures. Plan the schedules beforehand to avoid last minute hassle Communicate politely and professionally with clients / submission counters Ensure accurate labeling, packaging of the documents for the courier Handling courier documents with care and ensuring safe, undamaged delivery. Submission of the courier documents on a timely basis Support inventory management by updating stock levels of stationary materials, required materials Handle basic queries or direct them to appropriate support staff. Maintain accurate records of deliveries and collections. Submit daily reports to the senior authorities Provide administrative support to senior administrative staff Ensure the vehicle is well-maintained, clean, fueled and report any issues or damages immediately. Adhere to traffic rules and company safety guidelines. Ensure the office premises are clean, organized, and properly maintained. Assisting the office teammates for scanning, printing or any other day to day work Any other work assigned by the organization on a timely basis. Good verbal and written communication skills Ability to manage multiple client cases with attention to detail Problem-solving mindset with a focus on customer satisfaction Team player with the ability to work independently when needed Willingness to learn, adapt, and grow within a fast-paced environment.

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6.0 - 10.0 years

5 - 6 Lacs

Pune

Work from Office

Role & responsibilities Scrutinize the proposal with authorities follow up for sanctions. Check the drawings before scrutinizing. Knowledge of rules & regulations UDPCR as well as SRA Drafting submission drawings Preferred candidate profile Minimum 7 yrs experience in Liaison department with knowledge of UDPCR & SRA rules & regulations.

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3.0 - 5.0 years

3 - 6 Lacs

Mysore, Karnataka, India

On-site

Experience in Electrical design Preparation, submission / monitoring of techno - commercial offers for power distribution & special transformers as per customer satisfactions To attend the technical discussion meetings at the customer place during the tender and order stage. Designing of Power Transformers from 3.15 MVA to 50 MVA up to Voltage Class 220 KV & distribution and converter duty transformers from 20KVA to 3 MVA up to 33KV. Quick response to customer s clarifications & revision of offers when raised by customers. Follow up with branches for close looping of offers submitted & Co - ordination with branches on conversion of offer into orders, etc... Submission of Effective offers based on customer requirement & reasonable price offering with new design concepts keeping in view of the competitors. Effective training for sub ordinates for making optimum designs & effective offers. Maintenance of records as per ISO 9001 requirement.

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2.0 - 6.0 years

4 - 6 Lacs

Vadodara

Work from Office

Prepare, compile & submit dossiers for product registration, variations & renewals to regulatory authorities.Ensure compliance with current regulations, guidelines & standards for pharmaceutical products.Knowledge of CTD/ACTD format is must.

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2.0 - 4.0 years

3 - 4 Lacs

Mumbai, Mumbai Suburban, Mumbai (All Areas)

Work from Office

2–4 years of experience in the US Insurance domain. Support US Account Managers with: Loss run ordering, cancellations, reinstatements Premium comparisons, invoicing, quoting, and rating Use of systems like AMS360, ImageRight, Applied EPIC, Nexsure

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