331 Usfda Jobs - Page 4

Job Title: Manager / Sr. Manager Engineering (Projects) Location : Central India (Greenfield Project) Responsibilities- Overall experience in USFDA Injectable Plants, handling Qualification of HVAC, Designing, Installation, Commissioning Clean Utilities Black Utilities Overall, In charge of Piping, Utilities & HVAC Systems for installations at Site. Based on the received drawings & documents, assign work and timelines and ensures the implementation of the same. Ensure collection of data; do analysis to achieve relevant construction quality and safety. Help overcome constraints, work out alternatives to the design in case of difficulties Retention of records in respective area. Preparation & completeness of documentation for Qualifications. Give final acceptance of construction quality for piping and utilities. Review measurements sheets. Ensure schedule updates in primavera and send progress reports in terms of schedule work quantity, progress, constraints, snaps and etc. Coordination with Boiler Inspector and other statutory agencies Execute construction quality audits for piping and utilities. Responsible for construction quality; finishes, Operations, Performance and safety at site. He will report quantity variation and scope change Educational Qualification Bachelor's degree in Mechanical Engineering Experience : Tenure : 14 to 17 Years ( Pharmaceutical Industry with Injectable experience mandatory)

WALKIN DRIVE - REGULATORY AFFAIRS @ BARODA (FORMULATIONS) DATE : SUNDAY, 13TH JULY 2025 || TIME : 9.30 AM VENUE : SUN PHARMACEUTICAL INDUSTRIES LIMITED, NEAR AKSHAR CHOWK, SUN PHARMA ROAD, TANDALJA, VADODARA - 390012| DEPARTMENT : REGULATORY AFFAIRS - US MARKET | LABELLING | PLANT RA EXPERIENCE RANGE : 2-8 YEARS GRADE ; EXECUTIVE / SR EXECUTIVE JD: FOR US MARKET ; 1) Compilation , review of dossier for US , EU , AU, Canada & IL market (ORALS/NON ORALS) 2) Review of query response prepared and compiled by regulatory associates 3) Review of all the documents received from stake holder for dossier compilation , Query response and Life cycle management FOR LABELING: 1) Preparation and reviewing of labeling for ANDA and/or NDA applications and labeling query responses in accordance with the USFDA regulations. 2) Preparation of Structured Product Labeling (SPL) for drug listing in accordance with the associated applications and USFDA regulations FOR PLANT RA 1. Participates in activities related to new product registration/ new filing, re-registration, sample, queries of regulatory agency and variation filing. 2. Product life cycle management: review the Change control and provide final variation category. And arrange documents for Filing. And Activities related to variation management. 3. Approval package (Emerging Market): Co-ordination with corporate regulatory and plant team for impact analysis of proposed change against approved package and filing of variation whenever applicable Candidates having above experience can walk-in with their updated resume and relevant documents . Those unable to attend interview may share their cvs to : HR.Tandalja@sunpharma.com Disclaimer - Sun Pharma does not seek payment of any kind from a prospective candidates for employment with company or authorize any agency or any individual to collect or charge payment for recruitment. Please be cautious while dealing with any recruitment agency or anyone asking you to pay money representing himself to be part of Sun Pharma.

Long Description Annual maintenance contract preparation and preventive maintenance of QC instrument as per approved procedure. Breakdown handling of QC instrument as per approved procedure. Upkeep the records for preventive maintenance and breakdown in SAP. Qualification of New instruments with complete documentation. To participate in failure investigations related to instrument malfunctions. To impart training to the analysts for instrument maintenance and troubleshooting. Co-ordination with service engineer for service/ breakdown related activities To maintain good laboratory practices and discipline in respective work area. Actively taking part in cGMP, training and SOP training as and when required. Supporting for calibration and validation activity of Thermolab Make instruments. Competencies Innovation & Creativity Result Orientation Collaboration Customer Centricity Developing Talent Stakeholder Management Strategic Agility Process Excellence Education Graduation in Instrumentation Work Experience 5 to 7 years

At Allucent , we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a to Submissions Senior Publisher to join our A-team (hybrid). The Submissions Senior Publishe are responsible for preparation, compilation, and publication of electronic common technical documents (eCTD) and other regulatory submissions for investigational, new, and marketed drugs and devices. The Submissions Sr. Publisher has an increasing level of responsibility and is highly knowledgeable and experienced with complex types of submissions across different regulatory regions and Health Authority communications. In this role your key tasks will include: Manages submission timelines and activities for assigned projects to meet or exceed required deadlines Performs the formatting, compilation, and publication of regulatory submissions to meet or exceed sponsor and agency requirements and expectations Increases skills, knowledge and experience of increasingly complex documents, applications and submission types, amendments to existing applications for lifecycle management purposes. Develops knowledge and experience of submissions across different regulatory regions as corporate needs dictate Learns and keeps abreast of updates to regulatory guidance, law, and best practice related to job functionality. Mentors less experienced Publishers and Submissions Specialists Assists with development and presentation of internal and sponsor training. With increasing knowledge and experience, manages and oversees submission processes. May interact with project teams to educate sponsors on technical requirements for submissions. With increasing knowledge and experience participates in submissions software evaluation, selection, and validation. Assists with or leads development and improvement of internal best practices and standards for regulatory operations activities. Interacts with regulatory agency technical counterparts to resolve issues and Participates in interdepartmental communications to assist with compliance with regulations pertaining to eCTD and other submission types. Submissions Senior Publisher with direct line reports. Provides training to direct reports on current and new regulatory requirements for submissions/ Actively manages direct reports including development and performance management and Assists with evaluation of line report utilization and capacity. Actively participates in and leads staff learning & development within regulatory operations. Manages submissions team workload to meet or exceed sponsor deadlines. Coaches, mentors, and develops reports on collaborative consulting. Submissions Senior Publisher with or without direct line reports. Actively supports staff learning & development within the company. Provides guidance and advises Consulting Project Leads, and/or Project Teams on submissions requirements. Participates in meetings with clients to discuss submissions requirements. Provides mentorship to team members o Acts professionally with peers and clients, knows business etiquette. Draft and contribute as Subject Matter Expert (SME) in the field of Publishing activities to the evaluation/improvement of processes and procedures within the Quality Management System. Assure good communication and relationships with (future) clients Provides regulatory operations input to proposals and bids. Actively manages, develops, and strengthens client relationships, drives repeat business. Contributes and take part in client evaluations, visits and bid defenses. To be successful you will possess: B.S., M.S., Ph.D., or equivalent degree, in a scientific area preferred, and equivalent combination of relevant experience. Strong regulatory knowledge of drug, biolo

Education Graduation in Pharmacy Long Description The person should have knowledge in Manufacturing equipments. He should have exposure in equipment’s such as FBE,Fette/KORSCH M/C & auto coater M/C He should be able to handle equipment trouble shoot in Manufacturing department. He should have exposure in regulatory organization . He must have faced the USFDA ,MHRA & other regulatory audits. He should have the exposure in Caliber QAMS, elog, track wise ,SAP ,WIND ,CDAS & other software. He should have the exposure in process simplification/optimization ,SABA ,elog & SCADA. Competencies Work Experience 3-6 years work experience in Fette compression machine

Role & responsibilities Dossier Preparation in CTD/ACTD/Country Specific Formats 2. Re-registration and Renewal Application 3. Variation Application 4. Queries Handling 5. DMF Activity 6. Artwork Review (Carton/Foil/Label/Insert/Shipper) 7. Pack Insert Preparation as per Country Guideline 8. Documents and Sample Collection Activity from F&D, QA, QC and Store department for registration requirement. 9. Documents Review Knowledge: Pharmaceutical Development Report, Process Validation Protocol & Report, Excipients Specifications/MOA, Finished Product Specification/MOA, Packing Material Specification/MOA, COA, Stability Study Protocol & Report, MFR, BMR, BPR, Clinical/Non Clinical Literature Search Strategy, AMV, CDP, BE Study. Experience Required: CDSCO , USFDA, EUGMP, NAFDAC Dosage Form Experience Required: Tablets, Capsules, Oral Powder (Sachet), External Preparation (Gel & Cream), Injections, Infusions, Suspension, Syrup, Oral Drops, Suppositories.

Regulatory Affairs Executive ( for Cosmetic Industry ) Kheda, Gujarat 3–5 Years Experience CTC up to 6 LPA Strong knowledge of global cosmetic regulations (EU/USA/ASEAN/Gulf) Expertise in labeling, claims review, and documentation

To follow safety rules in the premises according to the company norms. Operation and Cleaning of glove integrity and filter integrity testers. Responsible to perform the in process checks during operation. Responsible for Dispensing, checking and receiving of PPM from warehouse on need basis. To ensure cleaning and storage of change parts as per the procedures. To maintain the BMRs and other log books in the compounding area as per cGMP and SOP Cleaning and maintenance of compounding area as per GMP and SOP Operation and cleaning of dynamic pass box in compounding area Responsible for Cleaning and sanitization of drain points in compounding area Responsible for manufacturing and supervising of Media fill and Drug products batches as per BMR To carry out CIP & SIP of the vessels related to compounding and flitration area. Responsible for operation, calibration and cleaning of weighing balance, pH meter, DO meter and conductivity meter, Compounding isolator, Manufacturing and filtration vessels, Heating & cooling skid, Air shower. Table mounted LAF and ceiling mounted LAF, Filter integrity tester, Sonicator , TFF, Homogenizer, Lipid extruder, Fogger, Heating magnetic stirrer with thermometer, SART system, Strip chart recorder Preparation and periodic revision of SOPs related to compounding area. Responsible for the co-ordination with cross functional departments like QA,QC, warehouse Engineering, HR and administration for the day to day activities. Activities other than defined in the job responsibility are to be done, as per the requirement of HOD, by following HODs instructions and guidance.

Industry: Payments/ Financial Services business Functional Area: Payments and Financial Services Role: Senior Manager Reporting to :Director Legal Key Skills: Drafting, vetting, and negotiating agreements, Providing legaladvice, Product counselling, Interpreting regulations and providing guidance to internal teams, Risk identification and Management. Experience: Minimum 10+years experience, including experience inPayments/ FinancialServices/ FinTech (required). Education University Degree in law. A Masters Degree in Law is not mandatory, but will be an added advantage. Location: Bangalore PRIMARY RESPONSIBILITIES : Business Reviewing existing products, as well as new products/ features, with the lens of ensuring they are in line with applicable laws and critical industry practices. Providing legal guidance to, and working closely with Compliance, Business and other stakeholders, in this regard. Drafting, reviewing, negotiating, and closing contracts (relating to the payments/ financial services business, banking contracts etc.) with the internal and external stakeholders, with a view to protect the organization against any legal exposure and to minimize liability. Provision of legal advice in framing/ review of policies, and other internal and external documents. Staying updated on the regulatory environment; identify, interpret, and analyse existing and new legislations/ amendments/ notifications that may impact business; and basis its applicability and implications, bring it to the notice of appropriate internal functions as required. Advise and assist all stakeholders including Compliance and Business on both, ongoing legal risks and anticipated/ new legal risks arising by virtue of new laws or regulations. Internal process Adhere to timelines in reviewing and vetting all documentations, including agreements. Follow up with internal stakeholders, including business leads,for time bound closure of agreements;provide advice in course corrections; escalate when required. Monitor the timelines for submission of applications pertaining to licences (new and renewals) to regulatory authorities and ensure timely escalation where required. Learning Maintain a database on applicable laws comprising FAQs, dos anddontsas a ready reference. Keep a track on the latest lawsand notifications (including all notifications issued by the RBI), and proactively advise the management and business about such laws/ amendments and its implication on business, and accordingly suggest changes in process/ procedure. PhonePe Full Time Employee Benefits (Not applicable for Intern or Contract Roles) Insurance Benefits - Medical Insurance, Critical Illness Insurance, Accidental Insurance, Life Insurance Wellness Program - Employee Assistance Program, Onsite Medical Center, Emergency Support System Parental Support - Maternity Benefit, Paternity Benefit Program, Adoption Assistance Program, Day-care Support Program Mobility Benefits - Relocation benefits, Transfer Support Policy, Travel Policy Retirement Benefits - Employee PF Contribution, Flexible PF Contribution, Gratuity, NPS, Leave Encashment Other Benefits - Higher Education Assistance, Car Lease, Salary Advance Policy Working at PhonePe is a rewarding experience! Great people, a work environment that thrives on creativity, the opportunity to take on roles beyond a defined job description are just some of the reasons you should work with us. Read more about PhonePe on our blog. Life at PhonePe PhonePe in the news

Educational Bachelor of Engineering,BTech,Master Of Engineering,MTech Service Line Engineering Services Responsibilities A day in the life of an Infoscion As part of the Infosys delivery team, your primary role would be to interface with the client for quality assurance, issue resolution and ensuring high customer satisfaction. You will understand requirements, create and review designs, validate the architecture and ensure high levels of service offerings to clients in the technology domain. You will participate in project estimation, provide inputs for solution delivery, conduct technical risk planning, perform code reviews and unit test plan reviews. You will lead and guide your teams towards developing optimized high quality code deliverables, continual knowledge management and adherence to the organizational guidelines and processes. You would be a key contributor to building efficient programs/ systems and if you think you fit right in to help our clients navigate their next in their digital transformation journey, this is the place for you!If you think you fit right in to help our clients navigate their next in their digital transformation journey, this is the place for you! Technical and Professional : Primary Skills: CTQ, QMS, ISO 13485, Design Documentation, CAPA, DHF Preferred Skills: Technology-CAD-CAD - Others

Role & responsibilities :- Hands on experience for BMR, Process validation report, Stability Protocol, Sampling Plan, Knowledge about GDP initiation and closure of Change control, deviation in GMP. Having good knowledge of guidelines SUPAC, cGMP, Compliance, ICH Q1A,Q2,Q7, Q8,Q9, A10, Q13. Knowledge about GAP assessment between sending unit and receiving unit equipment / instrument / documents. Hands on experience with Advanced Microsoft Word, Power point and excel Effective communication and Co-ordination with CFT. Sound Scale up/down knowledge Calculation, forecasting, Risk assessment etc. Plan Lab scale experiments and perform. Preferred candidate profile :- Must Have Experience in Tech Transfer Department Documentation. M. Pharma in Pharmaceutics Proficiency in MS- Word, Excel, PowerPoint Perks and benefits :- As per Company Standard

Key Responsibilities: Quality Systems Management: Implement and maintain Good Manufacturing Practices (GMP) in compliance with regulatory requirements (e.g., WHO, USFDA, MHRA). Ensure all processes and systems meet regulatory, corporate, and client quality standards. Manage and monitor the quality management system (QMS), including change control, deviations, CAPA, and risk assessments. Documentation & Compliance: Prepare, review, and update Standard Operating Procedures (SOPs) and quality assurance policies. Conduct internal audits and coordinate external audits and regulatory inspections. Maintain and ensure timely submission of quality documentation, including batch records, validation protocols, and reports. Product Quality Oversight: Perform in-process checks during manufacturing and packaging to ensure adherence to specifications. Review and approve batch records and certificates of analysis (COA) before product release. Investigate non-conformances and implement corrective and preventive actions (CAPA). Validation & Qualification: Support validation activities for equipment, processes, and cleaning procedures. Participate in qualification of facilities, utilities, and equipment. Training & Team Collaboration: Train staff on quality-related topics, including GMP and compliance requirements. Collaborate with cross-functional teams, including production, R&D, and regulatory affairs, to ensure quality objectives are met. Regulatory Compliance: Stay updated on current pharmaceutical regulations and quality guidelines. Ensure adherence to regulatory requirements for product registrations and submissions. Qualifications: Bachelors or Master’s degree in Pharmacy or a related field. Certification in GMP, ISO 9001, or other relevant quality standards is an advantage. 2 to 4 years of experience in quality assurance in the pharmaceutical industry. Key Skills: Strong knowledge of GMP, GLP, and regulatory requirements (e.g., FDA, EMEA). Excellent documentation and analytical skills. Proficiency in quality tools and techniques, including root cause analysis and CAPA. Attention to detail and problem-solving abilities. Effective communication and interpersonal skills.

Oversee all QA activities related to API manufacturing in line with cGMP and regulatory standards. Review and approve manufacturing and analytical documents including MBMRs, BPRs, validation protocols and reports. Lead handling of QMS activities. Required Candidate profile Strong knowledge of QMS, cGMP, ICH, WHO guidelines,Audit handling and documentation expertise,Leadership and team coordination,Proficiency in handling TrackWise / MasterControl or similar systems

Participate in internal and external audits (USFDA, EDQM, WHO, MHRA, etc.),Ensure compliance with GMP, ICH, and regulatory guidelines in API manufacturing.Conduct in-process checks and ensure batch release activities are done per quality procedures. Required Candidate profile Experience of QMS software Exposure to regulatory audits and good Manufacturing practices. Strong communication and documentation skills. Sound knowledge of regulatory guidelines ICH, WHO, USFDA

Responsible for formulation and process development of oral immediate-release dosage forms, including oral film and tablet formulations. Troubleshoot and problem-solve unresolved or new formula issue

Studies, and process optimization as per regulatory guidelines (USFDA, EU, WHO). Prepare and review development reports, PDRs, BMRs, MFCs, and technology transfer documents. Collaborate with cross-functional teams (QA, QC, RA, Production).

Manager Mobility Industrial Join our team in Strategy & Consulting to find endless opportunities and solve our clients' toughest challenges, as you work with exceptional people, the latest tech and leading companies across industries. Practice: Transportation and Logistics, Industrial Consulting, S&C Global Network (GN) I Areas of Work: Mobility & Transport Solutions| Level: Manager | Location: Delhi, Gurgaon, Mumbai, Bangalore, Pune, Hyderabad | Explore an Exciting Career at Accenture Are you a problem solver driven by impactful resultsDo you enjoy working on transformation strategies for global clientsDoes a collaborative and inclusive workplace energize you Then, Accenture Strategy & Consulting is where your potential can reach new heights. The Practice A brief Sketch Transportation and Logistics team within S&C GN Industrial Practice brings extensive expertise in driving operational efficiency and digital transformation across global mobility ecosystems. We specialize in digital transformations, end-to-end supply chain optimization, freight and fleet management, route planning and optimization, transportation management systems (TMS) implementation, mobility-as-a-service (MaaS), shared & autonomous mobility services, asset management, process automation and digitization, sustainability initiatives, advanced analytics and data-driven insights, IoT and asset tracking solutions, and industry benchmarking and best practices. Our approach leverages advanced technology to optimize logistics operations, reduce costs, and enhance customer satisfaction, positioning our clients at the forefront of the logistics and transportation industry. Globally, Accenture helps our clients crafting robust transport strategies, driving operational efficiencies, and achieving sustainability goals in logistics. We work on a range of projects, from long-term transformational system integration to short-term agile engagements, supporting our clients with: Mobility Strategy and Transformation: Work with clients to define the vision and roadmap for the future of mobility, focusing on on-demand services, shared & autonomous mobility models, and the seamless integration of mobility services through MaaS platforms. Smart Stations and Terminals Ideation: Lead efforts in designing and developing smart infrastructure solutions for both rail and multimodal hubs that incorporate IoT, digital ticketing, and predictive analytics to improve efficiency, customer experience, and sustainability Enhance Customer Experience: Help clients develop and deploy autonomous rail technologies, on-demand mobility services, multimodal transport systems (e.g., buses, ferries, rail), and high-speed rail systems that enhance flexibility, accessibility, and speed, while improving overall passenger satisfaction and reducing congestion Fleet Electrification: Accelerating adoption of sustainable, electric-powered fleets for various modes of transport including buses and rails, ensuring compliance with environmental regulations Sustainability Mobility :Partner with clients to transition fleets to electric-powered systems, implement energy-efficient routes, and support the adoption of sustainable practices that reduce carbon emissions and ensure compliance with evolving environmental regulations Bring your best skills forward to excel in the role: Skills in one or more of the following areas: Urban Mobility Expertise: In-depth knowledge of multi-modal transport systems (rail, bus, ferry), including high-speed rails, fleet electrification, and shared & autonomous mobility services. Mobility-as-a-Service (MaaS): Experience in integrating on-demand mobility services into existing transport infrastructures, creating seamless connections between multiple modes of transport. Fleet Electrification: Expertise in transitioning fleets (buses, rail) to electric systems, optimizing energy consumption, and reducing emissions. Smart Infrastructure: Knowledge in designing smart infrastructure solutions, smart stations, and bus/ ferry/ air terminals that incorporate the latest digital technologies to enhance efficiency and improve passenger experience. Autonomous and On-Demand Mobility Solutions: Familiarity with the integration of autonomous vehicles and on-demand rail services within existing mobility networks. Sustainability and Green Mobility: Strong understanding of sustainable practices in the rail sector and knowledge of how to implement green mobility strategies in line with industry standards and regulations. Advanced Analytics and IoT Solutions: Ability to leverage IoT, predictive analytics, and data-driven insights to optimize transport operations and asset management. Other required skills: Leadership and Team Development - Ability to lead, mentor, and develop teams, fostering collaboration and creating an environment of growth and continuous learning Stakeholder Management - Manage mid-level to senior client leadership and lead conversations Communication and Presentation - Plan and deliver well-structured oral and written communications Structured Problem Solving - Help identify and structure key client challenges into hypotheses and conduct analyses to address the challenges Program management skill with an ability to coordinate cross-functional teams, manage project timelines, and drive successful delivery within scope and budget Cross-cultural competence with an ability to thrive in a dynamic environment Your experience counts! MBA from a Tier 1 or Tier 2 school, or extensive industry experience in mobility services or consulting. 8+ years of progressive experience in mobility solutions, fleet electrification, and MaaS integration. Experience with smart infrstructure, autonomous mobility, and on-demand services. Certifications in Project Management (e.g., PMP, Prince2) and Agile methodologies are an advantage. Familiarity with Agile practices (e.g., Scrum, Kanban) and tools like JIRA to manage projects effectively. Experience in strategy and business/technology consulting role conversant with process improvement, cost optimization, customer analytics and experience management etc. Experience in value architecting, business case preparation, value realization Experience in Digital, New IT, Cloud & Core modernization, Cloud transformation processes, transforming legacy to the cloud, Agile transformation, RPA, AI/ML strategy implementation and use cases Knowledge of design thinking workshops and innovation Experience in large data analysis, data driven consulting, BI and analytics, reporting, dashboarding, visualization tools like PowerBI, Tableau For Experienced candidates, experience of team Management Coach and mentor team members in projects, on asset development, BDs and overall professional development Whats in it for you An opportunity to work on transformative projects with key G2000 clients Potential to Co-create with leaders in strategy, industry experts, enterprise function practitioners and, business intelligence professionals to shape and recommend innovative solutions that leverage emerging technologies. Ability to embed responsible business into everythingfrom how you service your clients to how you operate as a responsible professional. Personalized training modules to develop your strategy & consulting acumen to grow your skills, industry knowledge and capabilities Opportunity to thrive in a culture that is committed to accelerate equality for all. Engage in boundaryless collaboration across the entire organization. About Accenture: www.accenture.com About Accenture Strategy & Consulting: Accenture Strategy shapes our clients future, combining deep business insight with the understanding of how technology will impact industry and business models. Our focus on issues such as digital disruption, redefining competitiveness, operating and business models as well as the workforce of the future helps our clients find future value and growth in a digital world. Today, digital is changing the way organizations engage with their employees, business partners, customers, and communities. This is our unique differentiator. S&C Global Network (GN) a distributed management consulting organization that provides management consulting and strategy expertise across the client lifecycle. Our S&C Global Network (GN) teams complement our in-country teams to deliver cutting-edge expertise and measurable value to clients all around the world. come and be a part of our team. Qualification Years of Exp: 8+ years

The Red Hat Payroll team for Europe, the Middle East, and Africa (EMEA) is looking for a Payroll Analyst to join us in India. This role, you'll join a team that supports 31 Red Hat locations across EMEA. You will work in a fast-paced and complex environment that is deadline-driven. You'll report to the EMEA payroll manager and be responsible for ensuring the payroll is processed in an accurate and timely manner. What will you do: Prepare monthly payroll bureau submissions and review bureau-prepared payrolls for completeness and accuracy Process payments like net salaries to employees, tax payments, pension payments, etc. Manage month-end reporting of payroll general ledger Manage vacation accrual Manage annual returns and other statutory filings as they relate to payroll, payroll taxes, and benefits Ensure all restricted stock unit information is processed through the relevant country payroll Complete the monthly input and reconciliation process to ensure that payrolls are adequately checked each month and variances are corrected in a timely manner Maintain control over all documentation and processes in line with Sarbanes-Oxley (SOX) requirements Work with internal and external auditors as needed to ensure the integrity of payroll information Develop and maintain good working relationships with the payroll vendor and internal departments What will you bring: 8+ years experience processing high volume payrolls within a multinational environment; experience with organizations with 1000+ employees Awareness of statutory legislation and procedures relating to the EMEA payroll Ability to work on your own in a fast-paced environment to deliver results with a focus on accuracy and attention to detail Excellent English verbal and written communication skills Experience working under strict deadlines and ensuring compliance with company policies Interpersonal and teamwork skills Ability to translate business needs into pragmatic solutions and implement them Comfortable handling the ambiguity that occasionally arises in a global organization in a multi-country environment Solid Microsoft Excel and computer literacy skills Third-level qualification is a plus About Red Hat Red Hat is the worlds leading provider of enterprise open source software solutions, using a community-powered approach to deliver high-performing Linux, cloud, container, and Kubernetes technologies. Spread across 40+ countries, our associates work flexibly across work environments, from in-office, to office-flex, to fully remote, depending on the requirements of their role. Red Hatters are encouraged to bring their best ideas, no matter their title or tenure. We're a leader in open source because of our open and inclusive environment. We hire creative, passionate people ready to contribute their ideas, help solve complex problems, and make an impact. Inclusion at Red Hat Red Hats culture is built on the open source principles of transparency, collaboration, and inclusion, where the best ideas can come from anywhere and anyone. When this is realized, it empowers people from different backgrounds, perspectives, and experiences to come together to share ideas, challenge the status quo, and drive innovation. Our aspiration is that everyone experiences this culture with equal opportunity and access, and that all voices are not only heard but also celebrated. We hope you will join our celebration, and we welcome and encourage applicants from all the beautiful dimensions that compose our global village. Equal Opportunity Policy (EEO) Red Hat is proud to be an equal opportunity workplace and an affirmative action employer. We review applications for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, ancestry, citizenship, age, veteran status, genetic information, physical or mental disability, medical condition, marital status, or any other basis prohibited by law. Red Hat supports individuals with disabilities and provides reasonable accommodations to job applicants. If you need assistance completing our online job application, email application-assistance@redhat.com . General inquiries, such as those regarding the status of a job application, will not receive a reply.

Walk-in at Matoda Were currently recruiting for multiple positions at our SANAND manufacturing facility. If any role aligns with your experience, please bring your updated resume and walk in during the scheduled drive. Please find our current job requirements and venue details mentioned. Requirement : Injectable Manufacturing & Visual Inspection Aseptic operations/ QMS / SKID / Multi-vessel / SVP / Visual Inspector (Senior Officer / Officer / Associate) Experience - 01 to 05 Years Qualification - B. Pharmacy/ M Pharmacy / Msc /Bsc / Diploma / ITI Time and Venue : 12th June 2025, 09:30 Hrs to 14:00 Hrs SATURDAY ______________________________________________________ INTAS, Matoda facility Plot No. 457, 458 Sarkhej Bavla Highway, Matoda Village, Sanand, Taluka, Ahmedabad, Gujarat 382210 ______________________________________________________ We would be pleased if you forward or refer any of your colleagues matching the desired job roles. *Having relevant qualification only can attend the scheduled walk-in.

Walk-in at Matoda Were currently recruiting for multiple positions at our SANAND manufacturing facility. If any role aligns with your experience, please bring your updated resume and walk in during the scheduled drive. Please find our current job requirements and venue details mentioned. Requirement : Injectable Manufacturing & Visual Inspection Aseptic operations/ QMS / SKID / Multi-vessel / SVP / Visual Inspector (Senior Officer / Officer / Associate) Experience - 01 to 05 Years Qualification - B. Pharmacy/ M Pharmacy / Msc /Bsc / Diploma / ITI Time and Venue : 12th JULY 2025, 09:30 Hrs to 14:00 Hrs SATURDAY ______________________________________________________ INTAS, Matoda facility Plot No. 457, 458 Sarkhej Bavla Highway, Matoda Village, Sanand, Taluka, Ahmedabad, Gujarat 382210 ______________________________________________________ We would be pleased if you forward or refer any of your colleagues matching the desired job roles. *Having relevant qualification only can attend the scheduled walk-in.

KEY RESPONSIBILITIES: Delegating and directing service tasks, monitoring the progress of current projects, and managing service team members to ensure the team's objectives and sales goals are met. Handling customer complaints or concerns quickly and professionally to maintain good customer relationships and ensure repeat customers. Assisting with or performing administrative tasks, such as managing and updating invoices, processing new orders, and tracking inventory. Setting up and maintaining a service desk and evaluating its efficiency. Resolving service desk problems and improving service methods to increase the service desk's productivity and customer service. Monitoring department issues and client complaints to create methods to lessen recurring issues. Ensuring First Response Time, Complaint Handle Time, First Contact resolution are within the prescribed limits as directed by the Management. Auditing work and customer service to ensure the company's high standards, efficiency, and productivity goals are met. Ensuring Quality Standards as per ISO 9001, ISO 13485, CE MDD/MDR, USFDA, CDSCO standards and any other applicable standards and systems. Maintaining strong relationships with manufacturers, dealers, and sales representatives. Helping to train new employees in company procedures. Maintaining a strong working knowledge of industry regulations, restrictions, and laws, ensuring the company's adherence to these regulations, and remaining current on the industry's standards and new innovations, materials, tools, and processes.

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and rating, research and education, policies and procedures, quality assurance, patient services, and public relationsCoordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for Adaptable and flexibleResults orientationWritten and verbal communicationCommitment to qualityProcess-orientation Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Preparation and reviewing of labeling for ANDA and/or NDA applications and labeling query responses in accordance with the USFDA regulations. Preparation of Structured Product Labeling (SPL) for drug listing in accordance with the associated applications and USFDA regulations. Preparation, reviewing, timely submission and coordination of implementation of labeling based on FDA notifications and/or RLD labeling updates. Coordination of labeling related activities with cross functional teams for timely launch of products. Regulatory submission and filings, coordinating final labeling implementation and maintaining labeling artworks using various softwares. Communication with third parties or private label distributors to gather needs and requirements of changes/labeling development. Evaluation and coordinating with departments for REMS requirement for applications.

" Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, and Generics & APIs, comprising Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma. JGL in India has Research & Development units at Noida and Mysore. It has two manufacturing facilities one at Mysore, Karnataka and another at Roorkee, Uttarakhand, engaged in APIs and Dosage manufacturing, respectively. The manufacturing location at Mysore is spread over 69 acres and it s a USFDA approved site engaged in manufacturing of APIs, and caters to the sales worldwide. API portfolio focusses on Lifestyle driven Therapeutic Areas (CVS, CNS) and targets complex and newly approved molecules. The company is the market leader in four APIs and is amongst the top three players for another three APIs in its portfolio helping it maintain a high contribution margin. The manufacturing location at Roorkee, Uttarakhand is state of the art facility and is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA. This business focusses on B2B model for EU, Canada and emerging markets. Both manufacturing units are backward- integrated and are supported by around 500 research and development professionals based at Noida and Mysore. R&D works on Development of new products in API, Solid Dosage Formulations of Oral Solid, Sterile Injectable, Semi-Solids Ointments, Creams and Liquids. All BA/BE studies are done In house at our 80 Bed facility which is inspected and having approvals /certifications from The Drugs Controller General (India) and has global regulatory accreditations including USFDA, EMEA, ANVISA (Brazil), INFRAMED (Portugal Authority), NPRA(Malaysia), AGES MEA (Austria) for GCP and NABL, CAP accreditations for Path lab services. JGL s full-fledged Regulatory Affairs & IPR professionals ensures unique portfolio of patents and product filings in regulatory and non-regulatory market. Revenue of Jubilant Pharma is constantly increasing and during the Financial Year 2018 -19 it was INR 53,240 Million as compared to INR 39,950 Million during the Financial Year 2017-18. Kindly refer www.jubilantpharma.com for more information about organization. ",

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Analyst Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 3 to 5 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The incumbent will perform the regulatory operations tasks of bookmarking and hyper linking for granular components (documents) of submission in accordance with ICH guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components.Collect, collate and evaluate the scientific data gathered as part of R & D. Advise on legal and scientific restraints and requirements. Ensure the organization`s products comply with current regulations. Example; Build regulatory submission strategy, author CMC documents, and health authority packages etc. What are we looking for Adaptable and flexibleCommitment to qualityHands-on experience with trouble-shootingAgility for quick learningAbility to work well in a team Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy,Master of Pharmacy