224 Fda Jobs - Page 4

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

Job Description Overall Single Point of Contact for Quality IT Projects (such as LIMS, Chromatography, QAMS, EDMS, LMS etc.) Finalization of URS in alignment with sites (India + Global). Harmonization of system and processes in line with regulatory requirements and compliances. Testing and Validation of IT applications in line with URS for QA/ QC/ Common applications. Keeping organization up to date on the requirement for smart QA/ QC. Defining SOP and training of personnel. Supporting operational team. Keeping senior management updated on the organization status. Keeping senior management updated on the organization status. Facing Regulatory Audits at site as and when required. Keeping sites ready for all time audits. Work Experience 18 to 20 Years Education Post Graduation Masters in Science Competencies 1. Strategic Agility 2. Innovation & Creativity 3. Customer Centricity 4. Developing Talent 5. Result Orientation 6. Process Excellence 7. Collaboration 8. Stakeholder Management Budgets/Cost Control

Role & responsibilities Prepares the submissions (ANDAs, amendments, supplements including labeling, annual reports) to support commercial business and to be-in compliance to FDA regulations. Review CMC submission documents from regulatory perspective to meet scientific and technical requirements for acceptability and approvability by FDA. Escalate the review findings for a timely resolution. Leads labeling development for product launches and ensures that all labeling meets company and US regulating health authority specifications. Initiate/Review change control process and coordinate with other departments to ensure timely implementation. Prepare, review and submit eCTD submissions. Collaborates with Regulatory Affairs on submission and implementation strategy for labeling. Create and revise labeling. Proofread and verify all labeling to ensure accuracy and conformity with US FDA regulations. Prepare final printed labeling for FDA submissions (e.g. PDF, SPL, PLR format). Perform Drug listing. Preferred candidate profile Strong understanding of FDA, ICH, CMC and labeling requirements through all phases of development and life-cycle of the product. Proven proficiency with relevant FDA/ICH regulations & guidelines for labeling development, implementation, and compliance requirements, and applies understanding to business situations. Proven effectiveness with stakeholders in the labeling system from content development through commercial supply. Actively supports the systems, processes, and operations for development of and changes to labeling, and assures compliance to those procedures.

Skills: Technical experience with JD Edwards EnterpriseOne (8.12, 9.0, 9.1, 9.2) using the development toolsets. Need technical consultant not a functional consultant. Should have worked on at least one full cycle of JD Edwards Project implementation / Upgrade / Support with an experience in design and development of Oracle JD Edwards Enterprise One 9.1 and above, modules/suites In depth knowledge and expertise in Integration and Interops using BSSV , REST call/ Orchestrators, EDIs, Real Time Event (RTE),Batch Interface, Point to Point Integrations. Excellent business communication skills, negotiation skills, and presentation skills Expertise and hands-on of JDE ( preferably 9.2 ) technical tool set like ERW, FDA, RDA, Named Event Rules, C Business Function programming, Table Conversion, Workflow, BSSV , UDOs, One view report , CAFE 1, E1 pages, BI Publisher, Orchestrator. Understanding of JD Edwards applications, data, tables, and related systems, to create functional designs and technical specifications, for reports, conversions and integrations.

Support and Maintenance of customers Adobe Campaign Classic platform Responsible for handling tickets in Production environment Perform RCA on recurring issue and provide permanent fixes Monitoring of the workflow and taking corrective actions Coordination of system-related activities between user and multiple technical teams Responsible for the upkeep and maintenance of Adobe Campaign application servers and coordination with DBA's Understanding integration of Adobe with other applications. Primary Skills 4 to 5 years of support and development experience with Adobe Campaign Classic (Neolane) Experience in working with different Adobe Campaign modules, like; Message Centre, Content Manager, FDA, etc. Knowledge and experience with the following programming languagesHTML, XML, JavaScript and SQL Knowledge and experience of integrating Adobe Campaign with other system Basic knowledge on SQL and Unix Good communication and interpersonal skill and willing to travel if required as this roles involves directly working with end customer. Secondary Skills Good to have Adobe Campaign Classic Developer Expert certification

Knowledge of about Preparation of Dossier. Sound knowledge of about semi regulated and regulated markets like USFDA , EU , MHRA , TGA , ANVISA , Canadian market. Knowledge of addressing regulatory deficiencies. Exposure to regulatory audits. Review of DMF. Knowledge of filling the products to semi regulated markets and regulated markets. Location Hyderabad Apply to Job Send your resume to

Role & responsibilities Regulatory Affairs Associate Description: The Regulatory Affairs Associate I assist other members of Regulatory Affairs Management (RAM) and the Regulatory Therapy Area (TA) in obtaining and maintaining licences and applications in accordance with agreed regulatory strategy and client standards. The Regulatory Affairs Associate I is an individual contributor who applies regulatory domain knowledge and may work under supervision. Accountabilities/Responsibilities: Document management including uploading and tracking regulatory files and systems according to established CLIENTprocedures and regulatory requirements Planning, preparing and executing simple submissions, and assisting with the preparation and planning of regulatory dispatches Be the interface with health authority (HA) and their systems for designated regulatory tasks e.g., management of user fees, receipt of incoming FDA correspondence, ordering EudraCT number, EudraLink support, use of HA portals Responsible for the ordering and tracking of specific regulatory requirements such as registration samples, certificates of pharmaceutical products, legal documentation, e.g., letters of authorisation, power of attorney, translations of regulatory documentation Provide support across the group for assigned non-drug project roles & responsibilities e.g., function as a designated point of contact or superuser Provide guidance and knowledge sharing within the RAM skill group If required, support in activities such as scheduling of regulatory submissions, PBRERs, etc. Minimum Requirements Education and Experience Relevant qualification and/or experience in science Minimum 5 years of experience from biopharmaceutical industry, or other relevant experience Proficient verbal and written English Project management skills Experience in document management and tracking databases Preferred Experience Some regulatory/medical/technical experience Knowledge of CLIENTbusiness and processes Some knowledge of CLIENT”submissions, compilation, publishing and approval processes, standards, systems and tools Experience of collaborating with people from locations outside of India, especially Europe and/or USA Skills and Capabilities Good written and verbal communication skills in English Cultural awareness Proficiency with common document management tools Ability to work independently and as part of a team Focus on continuous improvement and knowledge sharing Internal and External Contacts/Customers Lead RPM and members of the Global Regulatory Execution Team (GRET) and Global Regulatory Strategy Team (GRST) Other R&D skill groups, e.g., GRO, Operations Regulatory, Patient Safety, Reg TA (GRL & Regional Leads) Marketing companies Health authorities External collaboration partners “client” Legal “CLIENT”vendors for translation, document authentication, etc. Interested candidate Kindly drop your updated resume to below mail id Nithya_kumar@persolkelly.com Regards, Nithya CONFIDENTIAL NOTE: By submitting your resume or personal data, you acknowledge reading and agreeing to our Privacy Policy. You hereby provide voluntary consent to the collection, use, processing, and disclosure of your data by us and our affiliates, in line with the Privacy Policy. and applicable laws. If you wish to withdraw your consent or have any concerns, you may submit a request to our designated consent manager, as outlined in our Privacy Policy. We prioritize your privacy. SECURITY NOTE: We at PERSOLKELLY India or our representatives, do not ask job seekers for fees, personal banking information, or payments through unofficial channels. Official communications will only come from @persolkelly.com. Report any suspicious activity to Contactus_in@persolkelly.com. Click here to find out how you can safeguard yourself from job scams

Design and execute manual test plans, test cases, and exploratory tests across web and mobile platforms (React, Flutter). Validate regression, integration, UI/UX, and backend flows with deep attention to clinical user paths and edge cases. Maintain traceability from user stories to test artifacts , ensuring FDA audit readiness. Perform root cause analysis in collaboration with developers; help triage and verify defects in dev and staging. Review release readiness by participating in sprint ceremonies and QA sign-offs. Ensure test artifacts, screenshots, and logs are well-maintained in compliance with documentation standards . Must-Have Skills 35 years in manual testing with a strong track record in healthcare, fintech, or similarly regulated domains . Hands-on experience testing web and mobile apps , particularly React and/or Flutter UIs. Solid grasp of test case design , exploratory testing, and regression planning. Experience with bug tracking, test management tools , and version control (e.g., Jira, TestRail, Git). Strong understanding of software development lifecycle (SDLC) and Agile methodologies. Comfort with documenting test results , logs, and user flows for compliance traceability. Nice-to-Have Familiarity with BDD tools (Cucumber/Gherkin). Exposure to FDA, HIPAA, or ISO 13485 compliance workflows . Experience working alongside automation pipelines or CI tools (e.g., Azure DevOps). Working knowledge of API testing (Postman, Swagger) and basic scripting.

Role & responsibilities : As a Regulatory Professional, the ideal candidate will be responsible to plan, prepare and submit high quality files to the authorities achieving fast approvals. The professional, act as an ambassador for assigned medical devices/device part of combination products. This role involves planning, coordinating and executing the regulatory tasks as required for existing device products in accordance with the Global Regulatory Device Strategy for the defined area of responsibility in collaboration with manager and colleagues. Preferred candidate profile

We are looking for a skilled Regulatory Engineer with 4 to 8 years of experience to join our team at Apptad Technologies Pvt Ltd. The ideal candidate will have a strong background in regulatory affairs and excellent analytical skills. Roles and Responsibility Develop and implement regulatory strategies to ensure compliance with industry standards. Collaborate with cross-functional teams to identify and mitigate regulatory risks. Conduct thorough analysis of regulatory requirements and develop effective solutions. Prepare and submit regulatory documents to relevant authorities. Monitor and report on regulatory changes that may impact the company. Provide training and guidance to internal stakeholders on regulatory matters. Job Strong knowledge of regulatory affairs and industry standards. Excellent analytical and problem-solving skills. Ability to work effectively in a team environment. Effective communication and interpersonal skills. Strong attention to detail and organizational skills. Familiarity with regulatory software and systems. Experience working in an employment firm or recruitment services firm is preferred. For more information, please contact us at 6566508.

Good understanding for regulations and policies issued by India, US FDA and EU, and ability to interpret international regulatory requirements. Excellent written, organizational, and communication skills is required, and have a flexible Required Candidate profile RA role in medical device,US FDA,EU Bachelor degree in Medical,Mechanical,Electric Life Science/other healthcare related majors 8yrs exp for RA role in medical device/pharmaceutical industry

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere For 70 years, our team has driven meaningful innovations in kidney care As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients? that is what Vantive aspires to deliver We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us At Vantive, you will become part of a community of people who are focused, courageous and dont settle for the mediocre Each of us is driven to help improve patientslives worldwide Join us in advancing our mission to extend lives and expand possibilities Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere For 70 years, our team has driven meaningful innovations in kidney care As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients? that is what Vantive aspires to deliver We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us At Vantive, you will become part of a community of people who are focused, courageous and dont settle for the mediocre Each of us is driven to help improve patientslives worldwide Join us in advancing our mission to extend lives and expand possibilities Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere For 70 years, our team has driven meaningful innovations in kidney care As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients? that is what Vantive aspires to deliver We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us At Vantive, you will become part of a community of people who are focused, courageous and dont settle for the mediocre Each of us is driven to help improve patientslives worldwide Join us in advancing our mission to extend lives and expand possibilities Summary A Manager for Acute Device Software will be accountable for the development of products and providing creative solutions associated with the design, development, and sustaining engineering for our new and existing software product portfolio The successful candidate will possess solid ?hands-on? technical/leadership abilities, an excitement and energy for product development, and a passion for their work and the impact it has on meeting the needs of patients Also, expected to deliver to the department vision that aligns with the organization's vision or strategic plan Based on significant technical expertise, reviews and approves complex design concepts and provides general directions to technical staff Utilizes solid understanding of theories and practices of a variety of disciplines to manage complex projects or programs within boundaries of quality, time and budget Acknowledged outside of business unit or division for input on programs of some magnitude Exhibits creativity and innovation in completing divisional and cross-functional/business unit responsibilities Essential Duties And Responsibilities Effectively communicate and realize vision and strategy for the organization that aligns with the business and patient needs Contribute to strategic planning and technical roadmap and accountable for tactical execution of development programs Leverages deep knowledge of software technology/process/therapy domain and budgets to drive solutions and product design realization Create strong engineering culture in team with strong focus on design and architectural thinking Ability to lead technical team in the group ensures clear accountability and operational excellence Foster a collaborative work environment with strong working relationship across business Ensures that succession planning and talent pipeline is in place for the team members across multiple functions and/or technical disciplines Establish processes for effective resource management from planning through execution in close collaboration with program management Experience in managing project teams involving SW architects, Project Leads and SW design/test engineers Good understanding of SDLC process and prior experience in software development and/or testing Demonstrated success in owning/delivering software projects Understanding of Healthcare domain (regulations and standards) and Medical software development process is a plus Create a culture and environment that attracts, develops, retains, and grows diverse and top talent aligned with organizational strategy Ensure effective performance management Demonstrates understanding of and adherence to FDA, ISO and IEC design control procedures, regulations and standards and ensures appropriate design controls are being adhered to during sustaining engineering efforts and new product development Takes ownership for the continuous improvement initiatives within the assigned function in alignment with business needs Identifies and builds technical competencies and system approach to realize all aspects of product development including innovation/ideation Drives effective collaboration with external partners Lead the development and integration of project System deliverables which may cross several disciplines; evaluate alternatives against agreed criteria Coach the team to select solutions, assess risks and for understanding full range of implications across the system Review and analyze proposals to determine if benefits derived and possible applications meet quality, cost and performance with future roadmap and sustenance considered Education And/or Experience Bachelors in Electronics or Computer Science or any other relevant engineering discipline, 12+ years of experience including 2+ yrs of functional leadership experience Comprehensive knowledge and understanding of software Engineering process and product development Experience in responsible for project planning and evacuation throughout the product lifecycle, defining the vision, and working closely to ensure customer satisfaction Must possess knowledge on Hardware-Software Integration test Systems/Software Engineering, Software development & testing Project Management, Quality Auditor Project Planning Product orientation and Risk Management Must be self-motivated, have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience Ability to manage multiple cross-functional teams simultaneously Ability to design and influence outside of immediate scope of responsibility Maintain industry contacts and be involved in industry interest groups Proven track record of management/leadership effectiveness Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information To learn how you can protect yourself, review our Recruitment Fraud Notice Show more Show less

B.Pharm / M.Pharm with 8 to 10 years of experience in Regulatory Affairs. To Review dossier prepared by executives & trainees & submit to client along with artworks for countries like ASIA, LATAM & ROW Market. Follow up with FRD & Microbiology Dept. Required Candidate profile Ensure that a company's products comply as per current ICH & Country Guidelines. To work on Renewals of Registration Certificate for countries. Courier of Legalized Documents such as COPP, FSC, POA. Perks and benefits Negotiable - Depending Upon Candidate & Experience

B.Pharm / M.Pharm with 8 to 10 years of experience in Regulatory Affairs. To Review dossier prepared by executives & trainees & submit to client along with artworks for countries like ASIA, LATAM & ROW Market. Follow up with FRD & Microbiology Dept. Required Candidate profile Ensure that a company's products comply as per current ICH & Country Guidelines. To work on Renewals of Registration Certificate for countries. Courier of Legalized Documents such as COPP, FSC, POA. Perks and benefits Negotiable - Depending Upon Candidate & Experience

B.Pharm / M.Pharm with 8 to 10 years of experience in Regulatory Affairs. To Review dossier prepared by executives & trainees & submit to client along with artworks for countries like ASIA, LATAM & ROW Market. Follow up with FRD & Microbiology Dept. Required Candidate profile Ensure that a company's products comply as per current ICH & Country Guidelines. To work on Renewals of Registration Certificate for countries. Courier of Legalized Documents such as COPP, FSC, POA. Perks and benefits Negotiable - Depending Upon Candidate & Experience

B.Pharm / M.Pharm with 8 to 10 years of experience in Regulatory Affairs. To Review dossier prepared by executives & trainees & submit to client along with artworks for countries like ASIA, LATAM & ROW Market. Follow up with FRD & Microbiology Dept. Required Candidate profile Ensure that a company's products comply as per current ICH & Country Guidelines. To work on Renewals of Registration Certificate for countries. Courier of Legalized Documents such as COPP, FSC, POA. Perks and benefits Negotiable - Depending Upon Candidate & Experience

B.Pharm / M.Pharm with 8 to 10 years of experience in Regulatory Affairs. To Review dossier prepared by executives & trainees & submit to client along with artworks for countries like ASIA, LATAM & ROW Market. Follow up with FRD & Microbiology Dept. Required Candidate profile Ensure that a company's products comply as per current ICH & Country Guidelines. To work on Renewals of Registration Certificate for countries. Courier of Legalized Documents such as COPP, FSC, POA. Perks and benefits Negotiable - Depending Upon Candidate & Experience

B.Pharm / M.Pharm with 8 to 10 years of experience in Regulatory Affairs. To Review dossier prepared by executives & trainees & submit to client along with artworks for countries like ASIA, LATAM & ROW Market. Follow up with FRD & Microbiology Dept. Required Candidate profile Ensure that a company's products comply as per current ICH & Country Guidelines. To work on Renewals of Registration Certificate for countries. Courier of Legalized Documents such as COPP, FSC, POA. Perks and benefits Negotiable - Depending Upon Candidate & Experience

Division Department Sub Department 1 Job Purpose Review the compliance level of site for deficiency response, prepare master validation protocol and report as per company quality policy and applicable regulatory guidelines Key Accountabilities (1/6) Collate, review and provide required work plans on received deficiencies to HO in order to respond to regulatory authorities in a timely manner Collect data from all SPOCs with respect to received work plan for review Escalate any delays in receiving response from unit with respect to work plan Review of collected data for work plan fulfilment Send data to HO for compilation of deficiency response Take follow up with HO to receive updated dossier for product updates Review Master Validation protocol and report for timely execution of validation batches and timely submission of documents in order to response for deficiencies Review master validation protocol and report within timeline Check major observation in other units documents also for improvement of validation documents at site Synchronize all units Validation documents for improvement of all units Key Accountabilities (2/6) Review annual product quality review report at units for completeness and data correctness to ensure compliance to cGMP requirements and audit readiness Collect APQR timely with units for review Review data with supporting documents for data authentication Check major observation with other units for improvement of documents at site Review, upkeep and issue regulated market technical agreements at site for execution of batches as per customer requirement Review and compile received technical agreements for comments Provide guidance for execution of batches and handling events as per customer requirement Provide training in department to improve awareness in audit and compliance with licencing department Take follow up with HO for providing fresh TA and pending TAs for products Key Accountabilities (3/6) Receive and distribute approval certificate, dossiers (TDP & RAP) and development report at unit for execution of new products smoothly Receive and check approval certificate, dossiers (TDP & RAP) and development report for distribution at site Update site on receipt of documents for handling execution of customer or market specific batches Coordinate with auditors and site teams for regulatory and customer inspection/ audit at site to meet regulatory expectation and acquire GMP approvals Prepare final draft of compliance to audit observation and check whether it is in line with cGMP requirement to avoid regulatory action and continual improvements Inspect audit prerequisites to support and prepare for external audits Coordinate with Units for preliminary draft response and prepare final draft within timeline Follow up for closure of compliance commitments Provide adequate, errorless and timely compliance to CQA Monitor implementation of CAPA derived in compliance by assessing current regulatory requirements and inspecting its effectiveness review Prepare and submit EPA annual production application for getting the establishment registration of unit V Key Accountabilities (4/6) Collect, compile and review raw data and finalise the same for timely submission of MHRA, UK interim update document to corporate as per agency requirement by tracking interim updates at a site level, for risk based inspection planning Coordinate with units for all the raw data, its review and finalization before submission to corporate Prepare pre-inspection compliance report after announcement of MHRA audit Drive continuous improvement initiatives in CQA to facilitate adherence to cGMP Review warning letters received by competitors, analyse the current scenario to ascertain gap and prepare an action plan to prevent such an occurrence at site Review audit observations received by other Cipla sites, analyse the current scenario to ascertain gap and prepare an action plan to prevent such an occurrence at site Participate in internal team for conducting self-inspection, report preparation, submission and compliance review, to evaluate adherence to cGMP Prepare and update procedures in line with current GMP requirements Key Accountabilities (5/6) Execute on time and errorless submissions by reviewing product license, all certificates for product registration and tender , staff approvals and other applications to adhere to legal requirements Collect, review and finalize applications for: Additional Product COPP Test License Renewal of drugs manufacturing license and WHO GMP certificate All certificates for product registration and tender Alcohol Quota FDA Staff Approval Site Layout Approval Submit and process above application to FDA (district, state, CDSCO) for time bound receipt of approval Communicate with FDA to resolve queries and follow ups to monitor status of application Review, maintain and distribute approved certificates to concerned stakeholders at site Track the consumption of alcohol quota allotted by state FDA under subsidized scheme as per the plan to manage optimum level of alcohol availability for smooth functioning of site Track the status of FDA approved staff at site to adhere to Drug and Cosmetic Act Track the status of quantity specific product license to monitor dispatch of such products and renewal of license in compliance to DCGI NOC condition Key Accountabilities (6/6) Support in CDSCO and state FDA inspection to be GMP compliant and getting product licence, FDA stall approvals by ensuring cross functional interaction Inspect audit prerequisites to support and prepare for CDSCO and state FDA audits Coordinate with Units for preliminary draft response and prepare final draft within timeline Follow up for closure of compliance commitments Provide adequate, errorless and timely compliance to CQA Monitor implementation of CAPA derived in compliance by assessing current regulatory requirements and inspecting its effectiveness review Major Challenges Delay in receiving data for allotted work plans from units may impact whole process of deficiency response hence to overcome this situation we are in continue follow up with units for timely response Major observation handling in validation documents impact on registration batch execution, leading to delay in filing of product hence to overcome this situation we share and resolve each observation with units timely with resolving strategy Lack of detailed compliance with appropriate root cause from user department Regular discussion and trainings is provided to unit Liaising with Government officials for availability and timely approvals of applications Key Interactions (1/2) SPOCs of process validation at site for timely review of master validation protocol and reports at the time document received for review (once or twice a month) SPOCs of APQR at site for timely review of APQR (monthly) SPOCs of RA at site for timely receiving of work plan response of deficiencies on (weekly) Unit QA heads in reference to audit readiness and preliminary draft response (need basis) CQA and A&C team for final draft response review (need basis) Key Interactions (2/2) FDA for processing and approval of application (need basis) Dimensions (1/2) Zero overdue compliance of deficiencies 100% adherence to provided timelines for review of documents timely Track and support in Top 07 projects Timely and errorless review of APQR at site Review should not exceeding 15 days from schedule Ensure quality score minimum of 90% for each month Timely and errorless preparation of tech transfer summary for site Data submission to corporate should not go beyond 5th of every month Average 30 audits/ year 100% adherence to timeline of compliance for various regulatory and customer audits No disruption is supply chain because of GMP approvals, product deficiency and product license For FDA: Approximately 150 additional product license 36 test license 40 certificates 290 COPP 5 staff approvals Dimensions (2/2) Key Decisions (1/2) Review observation provided for correctness and improvement of master validation protocol and report documents (To Unit QA) List of pending technical agreements with requirement of fresh TA to HO for regular execution of customer products Review observation provided for correctness and improvement of APQRs and FDA product license applications at site (To unit QA) Recommend to update correct data provided for deficiency response (To HO) Process of identifying root cause for the observation in various inspection and audit (to CFT) Key Decisions (2/2) Education Qualification Pharma/ M Licensing and registration (0-2 years) Relevant Work Experience Sound knowledge of cGMPs and regulatory guidelines and basic knowledge of computer system Show more Show less

Role & responsibilities Responsible for development, implementation, maintenance, and overall success of the companys quality and regulatory programs and strategies, including articulating quality standards and objectives, developing methods to embed quality into the product development and manufacturing processes, establishing vendor relationships and quality standards, and developing and implementing innovative programs to focus employees on improving product quality. Develop, implement, and support a comprehensive regulatory compliance strategy to meet global market requirements for our products and ensure alignment with our overall business strategy. Proactively partner with R&D, Marketing, and other groups to provide regulatory advice and guidance on meeting necessary requirements to place products on global markets. Ensure that regulated processes and systems are always inspection ready. Oversee the performance of internal and external audits. Review, edit, and maintain all departmental policies and procedures, including trainings, CAPAs, ECRs, and ECNs. Oversee the development of employees, talent, processes, and technology necessary to reach annual and long-term objectives as organizational leader for the QA/RA functions Serve as person responsible for regulatory compliance (PRRC). Other duties as assigned. Preferred candidate profile Extensive experience hosting regulatory inspections and interacting with regulators Strong understanding of global registration requirements and demonstrated track record of successful market access. Experience with computer software validation (CSV) and implementation for QMS and ERP software packages, including user requirements gathering and specification development, process workflow documentation, validation script writing, and IQ/OQ/PQ test case execution General understanding of ICH, cGMP, cGDP, FDA, ISO, MDR, Healthcare compliance and applicable regulations and industry standards regarding clinical research and regulation of medical devices Effective manager with ability to mentor and develop members of the QA/RA teams through coaching and effective performance management Proven ability to create culture of accountability and ownership Proven track record with establishing and maintaining strong internal and external partnerships. Must be able to work effectively at all levels in the organization in a matrix environment .and with external partners. Must demonstrate excellent written and verbal communication skills and work well with diverse teams and stakeholders in multiple locations. Must possess the ability to conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities to meet deadlines and prioritize work on multiple projects. Highly independent and self-motivated and integrates well within a team. Physical Demands Ability to travel. Qualifications: Bachelors degree required in a science, engineering field or related discipline. MBA is a plus Experience: 10 years of QMS experience and demonstrated leadership experience. Proficiency with ISO 13485, Good Clinical Practices (GCP), and Quality System Inspection Techniques (QSIT); CFRs parts 210 &211.

As the Product Manager for the Cios Fit Platform, you will be the strategic and operational owner of a unique surgery product platform, which is the only one engineered and made in India in SHS. The Cios Fit is a value-segment medical imaging solution designed for intraoperative use across a range of clinical specialties, including orthopedics, surgery and urology. The product is exported from India to 30+ countries and developing the global footprint and expanding the product platform to new clinical applications is key for the success of the platform. You will lead the product strategy, define market and user requirements, drive execution in R&D and SCM aligned with business goals, clinical needs, and regulatory standards. Your focus will be on ensuring the Cios Fit Platform expands its footprint and features while maintaining outstanding image quality, usability, reliability, and it meet the needs of clinicians and healthcare providers worldwide. Key Responsibilities Own the end-to-end product lifecycle of the Cios Fit Platform, from market analysis and roadmap definition to launch and lifecycle management. Collaborate with R&D, UX, Clinical Affairs, Marketing, Regulatory Affairs, and Service to shape and deliver the product vision. Translate clinical and customer requirements into clear product specifications and priorities. Analyze market trends, customer feedback, and competitive landscape to inform product decisions. Define product positioning, value propositions, and key differentiators in collaboration with the marketing team. Monitor product performance and customer satisfaction to guide improvements and extensions. Support regulatory submissions, risk assessments, and documentation in alignment with medical device regulations (e.g., MDR, FDA, IEC 60601). Lead customer engagements, coordinate customer use tests, product launch events, KOL interviews, site visits, and product demonstrations to gather insights and build advocacy. Coordinate product launch planning, sales enablement, and training for global markets. Regular travelling to Europe, China and other countries is necessary. Qualifications Bachelors or Masters degree in Engineering, Biomedical Engineering, Electrical Engineering, Medical Technology, or related field. 5+ years of experience in product management, ideally within the medical imaging or surgical technology industry. Strong understanding of imaging technologies (e.g., X-ray, fluoroscopy), surgical workflows, and clinical environments. Experience working in regulated medical device environments (MDR, FDA 510(k), ISO 13485). Proven track record of translating user needs into product solutions with measurable clinical and business impact. Excellent communication, leadership, and collaboration skills to work with global, cross-functional teams. Business-fluent English; additional languages are a plus.

Clinical SAS programming Location: Remote Immediate/15 D notice Experience: 10+ years Looking for a candidate who is into Clinical programming and report generation (excluding ADaM, SDTM, and TLF) who will be supporting data management team. (Candidates)clinical programmers play a crucial role in creating accurate reports. However, a significant challenge is that 1 in 3 candidates may be fake. Experience of Creating missing pages, patient profile reports, reconciliation reports Programming: BASE SAS, macros, SQL. Regulatory Knowledge: FDA, EMA, ICH guidelines. Soft Skills: Attention to detail, communication, problem-solving. BASE SAS Certified is Plus candidates should have created SAS reports for DM function.( E.g., missing pages report, reconciliation report, patient profiles etc). Key requirements: 1) SAS Programmers with a minimum of 10 years of experience in clinical SAS programming. Python is good to have skillset. 2) Min 5 years of SAS experience with good understanding of DM and clinical stake holder requirements. Additional details: Responsibilities include (but not limited to) design, development, implementation, and validation of programs created in SAS dashboard applications, to process, analyze and report clinical trial data for review by clinical study teams. Works within established frameworks and ensures high quality is built into own deliverables. Works independently for well-defined scope of work Under guidance, creates catalogue of reports to aid data cleaning activities with moderate scope and medium complexity, but not limited to: Automate manual checks. Automate reconciliation and program edit checks for TPV data to ensure quality. Create tools and repository to minimize data errors at source for collection of lab reference ranges. Program reports to identify missing pages and also detect errors at Subject level. Create reports to measure metrics that can help assess data cleaning status. Create visualizations and dashboards to identify discrepancies in EDC and TPV data. Maintain created catalogue of reports and perform updates based on ongoing changes to requirements. Provide support as required to ensure availability and performance of developed reports and dashboards for both external and internal users Responsible for completion of documentation associated with programming tasks (e.g. peer review, report specifications etc.) in compliance with applicable SOPs Proactively keeps the lead programmers updated on progress of deliveries. Contribute to implementation of cross-functional projects that are part of clinical programming roadmap.

We are seeking a skilled Analyst with hands-on experience in FTIR/Disso/UV/KF/HPLC/GC techniques(Multiple requirements). The candidate should be well versed with Method Development, Method Validation and routine analysis. Required Candidate profile It is on the rolls of Cotecna Life Sciences India Pvt Ltd(Erstwhile Geochem Laboratories) If interested please share profiles on nilesh.kadam@geochem.net.in or any more information call on 9870476784

The Strategy & Consulting Global Network Song Practice| Service | Life Science Manager (Level 7) Join our team of Strategy & Consulting Global Network Song who solve customer facing challenges at clients spanning Sales, Service and Marketing to accelerate business change. Practice: Strategy & Consulting Global Network Song I Areas of Work: Life Science, Service transformation, Contact Center, Platform Enablement viz. Vlocity CPQ, Veeva CRM, Salesforce Health Cloud, etc | Level: Manager | Location: Bengaluru, Gurgaon, Mumbai, Chennai, Kolkata Hyderabad | Years of Exp:8 + years Explore an Exciting Career at Accenture Are you passionate about scaling businesses using in-depth frameworks and techniques to solve customer service challengesDo you want to design, build and implement strategies to enhance business performanceDoes working in an inclusive and collaborative environment spark your interest Then, this is the right place for you! Welcome to a host of exciting global opportunities within Accentures Strategy & Consulting Global Network Song practice. The Practice A Brief Sketch The Strategy & Consulting Global Network Song practice is aligned to the Global Network Song Practice of Accenture and works with clients across their marketing, sales and services functions. As part of the team, you will provide transformation services driven by key offerings like Service Transformation, Marketing Transformation, and Commerce and Sales. These services help our clients become living businesses by optimizing their marketing, sales and customer service strategy, thereby driving cost reduction, revenue enhancement, customer satisfaction and impacting front end business metrics in a positive manner. The Life Science Senior Manager position is within the Service practice of Accenture GN Song. The individual would work at the heart of the top global Pharmaceuticals, Biotechnology and Medical Technology organizations and would collaborate on innovative projects while bringing in deep industry knowledge to enhance Patient and HCP experience. You will work closely with our clients as Consulting Professionals who design, build and implement strategies that can help enhance business performance. As part of leading the project teams, you will drive the following: Consulting & Advisory service Lead a team responsible for designing, developing and implementing plans on delivering consulting services that improve service delivery, customer engagement, operational efficiency, and market success. Aid clients to adopt digital solutions to increase their competitiveness and accelerate GTM. Develop and implement solutions to address client challenges , such as improving patient outcomes, optimizing supply chain management, enhancing regulatory compliance, and accelerating product commercialization. Drive the adoption of technology capabilities while ensuring compliance with pharma industry regulations (e.g., HIPAA, GDPR, FDA, EMA) and data security standards. Assist Life Science clients with their most pressing service transformation problems by offering consulting and advisory services. Create a service transformational plan, close the gap between business and technology , and help clients achieve long-term success by co-creating future-proof, agile and resilient operating models. Develop and oversee Life Science components such as care management, patient journeys, appointment scheduling, and data integrations with other systems. Build and maintain client relationships , both existing and new, by understand client problems, bringing relevant solutions and offerings to the clients and influence improvement objectives Provide solutions to complex business problems /opportunities requiring in-depth knowledge of Patient and HCP dynamics, to optimize business processes and deliver on multi-channel customer service strategy. Data and Analytics driven approach highly essential powered by GenAI orchestration for identification and realization of value for the clients and help in driving measurable outcomes through digital investments at the right pace and scale. Recommend and implement digital solutions (e.g., automation, cloud platforms, AI and machine learning tools) to streamline operations and enhance service delivery. Sales & Business Development Generating new business engagements :Drive new business opportunities by identifying and pursuing new leads, defining GTM strategy, facilitate client discussions and presentations to drive new business and client relationships. Work as an integral part of the clients sales / channel development organization. Work towards driving sales and revenue numbers with a structured, logical and dataoriented approach, conducting Market Opportunity. Own and drive Service transformation RFP/RFI response coming in from Life science customers. Practice Development - Strong consulting and advisory experience in Life Sciences industry with deep industry knowledge and understanding of key trends. Take on leadership role: Support overall growth of practice area through a combination of business development, talent management, oversight of delivery work, and thought leadership. Collaborate with Salesforce, Adobe, Nice, MS Dynamics, Genesys etc. business groups, to enable business capabilities with agility, velocity, and quality while optimizing costs. Lead and motivate teams with diverse skills and backgrounds. Manage and mentor talented teams of consultants and technologists supporting, providing input and guidance into the talent strategy and actively participate in engagement, capability development activities. Experience in working as an advisory lead in designing next gen service transformation solution on digital technologies like Vlocity CPQ, Veeva CRM, Salesforce Health Cloud, Data automation and AI tools. Adept with working knowledge of Gen AI based technologies and tools such as ChatGPT, Gemini, DallE, Midjourney, Anthropic, Amazon Bedrock, LLama etc. Capable of using GenAI within applications such as Salesforce, Adobe and MS Dynamics. Understanding on healthcare delivery models, reimbursement systems (e.g., insurance, public health systems), and patient access programs. Bring your best skills forward to excel at the role: Strong consulting and advisory experience in Life Sciences industry with deep industry knowledge and understanding of key trends. Expertise in patient-centric services, healthcare delivery systems, or operational models in life sciences. Deep understanding of Health Care processes, performance drivers & industry leading practices, regulatory and compliance requirements. Understanding of market access strategies for pharmaceuticals and medical devices, pricing and reimbursement, payer negotiation, health economics, and outcomes research (HEOR). Ability to develop long standing relationships with senior client stakeholders. Experienced in managing large global teams, multi-stakeholder environments and complex digital projects engagements in a global network. Strong program management/ people management skills. Experience working with C level executives. Problem solving and conflict management. Ability to work effectively in a remote, virtual and global environment. Read about us. Whats in it for you An opportunity to work on with key G2000 clients Potential to 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 into everythingfrom how you service your clients to how you operate as a responsible professional. Personalized training modules to develop your to grow your skills, industry knowledge and capabilities Opportunity to thrive in a that is committed to accelerate equality for all. Engage in boundaryless collaboration across the entire organization. Qualification Your experience counts! Minimum 8+ years of relevant experience in Life science industry with good analytical skills along with domain experience. Working knowledge of Veeva CRM or Salesforce Health cloud and AI tools. Implementation experience is a plus. Demonstrated sustained client relations management experience at a C-suite level or operated at a senior management level in the industry role. Familiarity with healthcare technologies such as CRM, Electronic Health Records (EHR), Laboratory Information Management Systems (LIMS), and patient management platforms. Knowledge of allied service transformation capabilities such as speech analytics, workforce management, CX, etc. is a plus. Travel may be required for this role. The amount of travel will vary from 25% to 100% depending on business need and client requirements.

: Job titleBond Analytics Analyst Corporate titleAVP LocationBangalore, India Role Description OverviewBusiness Division Deutsche Banks Corporate Bank (CB) a market leader in cash management, trade finance & lending, securities services and Trust & Agency Services. Focusing on the treasurers and finance departments of corporate and commercial clients and financial institutions across the globe, our universal expertise and global network allows us to offer truly integrated and effective solutions. OverviewBusinessTrust and Agency Service (TAS): With offices in New York, California, London, Frankfurt, Milan, Lisbon, Dublin, Hong Kong, Singapore and Tokyo, the Trust and Agency Services team at Deutsche Bank has long been recognized as a leader in the provision of administrative and fiduciary services to the global debt and equities markets. It supports structures from the simplest to the most complex, covering Asset Backed Securities, CLOs and Managed accounts, Corporate Debt, Escrows, Project Finance, Loan Agency, and Depositary Receipts. OverviewTeam: TAS Analytics group within Corporate Trust business of Deutsche Bank is supporting the Structured Finance products like ABS/MBS/CDOs and other Debt products like Syndicated Loan transactions where DB acts as Trustee and/or Agent. As Trustee and/or Agent, DB is responsible for performing various calculations including but not limited to Bond Payments and Tax Calculations for new and existing bond issuances. Group has exposure to Corporate Trusts business in understanding the Structured Finance and other Debt products and its Analytics requirements along with supporting the CSG activities. The successful candidate will be required to cover European working hours supporting the EMEA/Americas business. Corporate title will depend on the relative experience of candidate. What well offer you 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Accident and Term life Insurance Your key responsibilities Read and interpret governing legal and issuer documents namely Prospectuses/Offering Circulars, Bond Indentures and Pooling and Servicing Agreements, Hedging Agreements, etc. Process and review Bond Payments for MBS, ABS, CDO and similar kinds of structured product deals in an In-House platform (iMAKE) based on the Offering Circulars/Indenture/Pooling & Servicing Agreement and using the best practices followed in the Group. Offer the highest level of customer service by understanding overall deal structure and bond payments to provide internal and external clients with explanations to support cash flow model output. Establish the guidelines for receipt and appropriate format of underlying asset-level collateral that supports bond payments, as well as research and resolve any data accuracy issues. Involvement in ad hoc/special projects which support process improvement and the implementation of technology initiatives. Understand and analyze issues and offer practical solutions. Working independently with a minimal degree of supervision is required to exercise independent judgment. Your skills and experience Bachelor of Science/Engineering or qualified CA/CFA with a high GPA and a minimum of 2 years of professional experience. Previous experience in developing cash flow models, and exposure to securities industry. Must have proven skills in MS Excel and/or MS Access with good scripting skills in VBA. Experience in using SQL Demonstrated ability to handle multiple and often competing projects under tight deadlines and pressure. Must project a Customer/Client service focus. Responsible for supporting efforts to mitigate and control operational risk. Must be organized, focused, and possess strong communication and analytical skills. Demonstrated ability to work and think independently, while supporting team goals/objectives. How well support you About us and our teams Please visit our company website for further information: https://www.db.com/company/company.htm We strive for a culture in which we are empowered to excel together every day. This includes acting responsibly, thinking commercially, taking initiative and working collaboratively. Together we share and celebrate the successes of our people. Together we are Deutsche Bank Group. We welcome applications from all people and promote a positive, fair and inclusive work environment.