13 Mastercontrol Jobs

Company Overview: One Vector is a rapidly growing IT professional services startup specializing in AI/ML, Data Science, Analytics, IT Quality/Compliance, and Pharmacovigilance for biotech companies. Our mission is to empower biotech organizations with cutting-edge solutions and expert insights to drive their success. As we continue our rapid expansion, we are seeking a dynamic and experienced Computer System Validation (CSV) Specialist to join our team. Position Overview: We are seeking a highly skilled and motivated Software Validation Engineer professional to lead and support the validation lifecycle of GxP regulated computerized systems. In this client-facing role, the ideal candidate will have a strong background in computer systems validation (CSV), quality systems, and Software Development Life Cycle (SDLC) principles. This role is pivotal in maintaining the integrity, reliability, and compliance of digital systems supporting manufacturing, laboratory, and business functions for our clients. This candidate will act as a trusted advisor to our clients, guiding them through the complexities of regulatory compliance while also ensuring the effective implementation and ongoing management of their computerized systems and Lifecycle procedures with Data Integrity requirements. Exceptional communication skills and the ability to forge strong relationships with clients are essential for this role. The successful candidate will be strategic, results-oriented, and committed to driving the company's growth in the biotech sector. Key Responsibilities: Lead validation activities across the full lifecycle of GxP systems including planning, testing, deployment, and periodic review. Develop and review validation deliverables such as Validation Plans (VP), User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Traceability Matrices (RTM), Test Protocols (IQ/OQ/PQ), Validation Reports (VR), and DM (Data Migration) Protocol & Scripts. Oversee vendor qualification assessments and documentation reviews and approvals to ensure third-party systems align with client validation expectations and regulatory standards. Guide clients through the validation process to ensure compliance with regulatory standards such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 Conduct risk assessments for computerized systems to identify potential gaps in compliance. Review and identify validation deviations and resolve deviations with appropriate corrective/ preventive actions Develop validation strategy and documentation for cloud-based and SaaS GxP systems, ensuring alignment with client IT controls, cybersecurity policies, and data residency requirements. Provide Quality Review and Assessment of associated change requests related to processes, IT infrastructure, equipment and computer systems. Manage project governance, including providing progress updates of the assigned deliverables, driving timely closures of escalations and facilitating strategic decisions with senior management. Provide recommendations for mitigating risks related to data integrity, security, and system functionality. Develop Standard Operating Procedures (SOPs) and work instructions for clients to support ongoing system use and compliance. Stay updated on regulatory changes in the life sciences industry and advise clients on how these changes impact their QMS software validation efforts. Provide guidance on data integrity principles and ensure alignment with industry standards. Responsible for other duties and projects assigned Qualifications: Required: Bachelor's degree in engineering or scientific discipline. IT Quality Assurance professional with a minimum of 9 years of experience with computerized system validation in Life Sciences industry. Experience validating systems such as LIMS, MES, ERP, QMS, or other laboratory/manufacturing software. Proficiency in authoring, reviewing and executing computer validation documentation (URS, VP, Specification documents, FRA, IQ, OQ, PQ, RTM, VSR). Proven track record of working with regulatory and industry frameworks such as FDA 21 CFR Part 11, EU Annex 11, GAMP 5, SDLC. Ability to work independently and collaboratively across cross-functional teams. Familiarity with audit readiness and experience supporting regulatory inspections or internal audits. Preferred: Master’s degree in a relevant discipline. Experience with QMS software implementation is highly desirable. Experience working with SaaS systems, data integrity programs, and GxP cloud validation strategies. Familiarity and/or industry certification with tools like ARISg database, QMS software platforms such as MasterControl, Veeva Vault QualityDocs/Quality Suite/Safety, paperless validation tools (Kneat, ValGenesis, or similar). Experience of working for US/EU based clients is a plus Show more Show less

Company Description zipp.ai is building AI to improve Food & Drug Quality. We are revolutionizing Quality & GxP compliance for Pharma and Food industries. Our mission is to ensure 100% compliance with Good Manufacturing Practices (GMP) by proactively detecting deviations and analyzing process gaps. We provide innovative solutions to tackle quality and compliance challenges faced by manufacturers, leveraging advanced technology and AI to enhance product quality and operational efficiency. Why Join zipp.ai? Foundational Role: Be one of the first implementation experts in a growing company, with the opportunity to define our customer onboarding and success playbook. High Impact: Your work will directly impact customer satisfaction, retention, and the overall success of zipp.ai. Cutting-Edge Technology: Work at the intersection of AI and the critical Life Sciences compliance domain. Growth & Mentorship: Collaborate directly with an experienced founding team in a fast-paced learning environment. Competitive Compensation: We offer a competitive salary and the potential for equity (ESOPs) as a core team member. Role Description As our SaaS Implementation Consultant, you will be the bridge between our innovative AI platform and our clients' complex GxP environments. You will be responsible for the entire post-sale customer journey, from initial discovery and solution design to configuration, training, and ongoing support. Your work will be critical to ensuring customer success, driving adoption, and building the foundation for long-term partnerships. Key Responsibilities Needs Assessment: Lead discovery workshops with clients to deeply understand their specific GxP processes, quality systems, document hierarchies, and compliance requirements to ensure our solution is tailored to their needs. Solution Design: Plan and architect the end-to-end implementation strategy, including defining configuration specifications, mapping data flows, and planning integrations with existing client systems (e.g., QMS, DMS). Configuration and Testing: Configure our AI platform according to the solution design, including setting up user roles, workflows, and initial rule sets. You will also manage and support User Acceptance Testing (UAT) with the client. Training and Onboarding: Develop and deliver comprehensive training materials and sessions for various user groups, from SMEs and QA to general users, guiding them through a smooth onboarding process. Issue Resolution: Act as the primary technical point of contact for clients during implementation, expertly troubleshooting and resolving any functional or technical issues that arise. Project Management: Manage the implementation project lifecycle from kickoff to go-live, creating project plans, tracking progress against milestones, managing scope, and ensuring deadlines are met. Customer Support & Success: Provide post-go-live support to ensure clients are successfully using the platform, while gathering feedback to share with the product and engineering teams for continuous improvement. Skills & Qualifications We Require Proven experience in a client-facing role, such as SaaS implementation, technical consulting, or solutions architecture. Technical Skills: Solid understanding of SaaS architecture, cloud technologies (e.g., Azure), API integrations, and software development lifecycles. Communication Skills: Exceptional verbal and written communication skills, with the ability to explain complex technical concepts to both technical and non-technical stakeholders. Problem-Solving Skills: A strong analytical and systematic approach to identifying, troubleshooting, and resolving complex issues. Project Management Skills: Demonstrated ability to manage projects, prioritize tasks, manage timelines, and communicate status effectively. Business Acumen: A good understanding of general business processes and the ability to connect technology solutions to tangible business value like efficiency and productivity. What Will Make You Stand Out (Preferred Skills) Experience in the Pharmaceutical, Food, or Medical Device industries. Strong knowledge of GxP regulations (GMP, GCP, etc.) and quality management principles. Quality Assurance professional, or experience with Quality Assurance projects 1-2 years of consulting experience Experience with common Life Sciences systems (e.g., Veeva Vault, MasterControl, TrackWise, LIMS, MES). Prior experience implementing AI/ML-based SaaS products is a significant plus. If you are driven to build intelligent solutions that have a real-world impact on product quality and safety, we would love to hear from you. How to Apply: Please apply directly via LinkedIn or send your resume and a 20-words write-up on "What makes you different from other candidates?" to hr@zipp-ai.com Show more Show less

Documentation Specialist in a clinical research organization Location: City: Hyderabad Department: Regulatory bodies / Quality Assurance / Ethics Committees Reports To: Head of Department Employment Type: Full-Time Gender: Male Job Summary: The Documentation Specialist is responsible for managing, organizing, and maintaining regulatory, clinical, and operational documents in compliance with applicable guidelines and company SOPs and license conditions. This role ensures accuracy, completeness, and timely availability of critical records to support audits, inspections, and operational continuity. Key Responsibilities: Develop, format, and maintain controlled documents (SOPs, protocols, study reports, manuals, etc.) Ensure version control and proper archiving of all documentation. Collaborate with cross-functional teams to obtain necessary approvals and implement document updates. Track and manage documentation workflows using electronic document management systems (EDMS). Prepare regulatory submissions and assist in compiling dossiers for regulatory bodies (e.g., CDSCO, DCGI, USFDA, EMA). Maintain master files for clinical studies and Ethics Committees (EC/IRB). Support internal and external audits by retrieving required documentation promptly. Conduct periodic document reviews and coordinate training record updates for SOP revisions. Maintain confidentiality and data integrity across all records and communication. Qualifications: Pharm-D or PG with Clinical Research Course. Minimum 2-3 years of experience in documentation, preferably in a healthcare, pharmaceutical, or CRO environment. Familiarity with GCP, ICH, and regulatory guidelines. Experience with EDMS (e.g., MasterControl, Veeva Vault) is an advantage. Excellent written and verbal communication skills. Strong attention to detail and organizational abilities. Great in coordination Preferred Skills: Knowledge of regulatory filing formats (e.g., eCTD); SUGAM PORTAL; SAE-Handling; conducting meetings and able to handle multiple clinets on daily basis. able to handle heterogeneric types of research proposals Proficiency in MS Office Suite (Word, Excel, PowerPoint, Outlook). Ability to manage multiple priorities and meet deadlines. Experience in handling Ethics Committee or regulatory submissions is a plus. Job Types: Full-time, Fresher Pay: ₹18,883.04 - ₹21,319.24 per month Benefits: Health insurance Provident Fund Schedule: Day shift Rotational shift Weekend availability Supplemental Pay: Overtime pay Performance bonus Yearly bonus Work Location: In person Application Deadline: 30/06/2025

Position Summary The Senior Regulatory Administrator (SRA) provides essential administration and operational support to the Regulatory Affairs department, overseeing the efficient management and maintenance of regulatory documents within the regulatory systems. This role is pivotal for ensuring that regulatory documentation is accurate, compliant, and submitted in a timely manner to regulatory bodies such as the FDA, EMA, and other international authorities. The SRA supports the department by managing the organization of regulatory documents for submissions, , ensuring compliance with relevant guidelines and regulations. The SRA involves in optimizing processes, mentor team members, and collaborating across departments to enhance our regulatory operational Essential functions of the job include but are not limited to: Upload, organize, and maintain regulatory documents within applicable regulatory authority submissions portals (e.g. Clinical Trial Information System (CTIS), FDA eGateway, Common European Submissions Platform (CESP), etc.). Coordinate the redaction of confidential and proprietary information in regulatory documents, ensuring compliance with global standards. Liaise with external vendors for document redaction services and track the progress of redaction processes. Assist in preparing, formatting, and completeness checking documents for regulatory submissions (e.g., FDA, EMA, and other global regulatory authorities). Support the creation of regulatory submission packages, ensuring adherence to technical guidelines, as advised by Regulatory Manager Provide publishing and technical support for submission documents, including conversion to compliant formats (e.g., PDF, eCTD). Assist under the guidance of Regulatory Manager in auditing and reviewing regulatory submissions for accuracy, completeness, and adherence to submission standards. Maintain current knowledge of evolving regulations and communicate updates to the Regulatory Affairs team. Maintain up-to-date tracking logs for submission timelines, regulatory approvals, and document status. Assist with internal audits and inspections by preparing required regulatory documentation and facilitating communication between stakeholders. Mentor, train and supervise junior Regulatory Administrators by providing guidance and support. Resolve complex issues related to submission document upload, publishing and system functionality. Contribute to planning and process improvement to enhance regulatory operation. Collaborate with cross functional teams. Participate in department meetings to stay informed of regulatory updates, project timelines, and submission requirements. Ensure all activities are conducted in compliance with relevant regulatory guidelines and company policies. Qualifications Minimum Required: Bachelor’s degree, or equivalent experience, Computer literacy (MS Office/ Office 365) Fluent in English, both written and verbal. 3 years in document management Preferred Previous experience in clinical research, regulatory affairs, or a related field, particularly within a CRO, pharmaceutical, or biotech company. Advanced knowledge of CTIS system and experience submitting clinical trial applications under the Clinical Trial Regulation (CTR). Previous Knowledge compiling and publishing, including eCTD. Understanding of global regulatory requirements and guidelines, including FDA, EMA, and other regulatory bodies. Experience with document management systems (e.g., eTMF, Veeva Vault, MasterControl) and electronic submission formats (eCTD). Competencies Strong attention to detail and accuracy in handling regulatory documents. Excellent organizational and time management skills, with the ability to prioritize tasks and meet deadlines. Excellent communication and interpersonal skills, capable of interacting with internal teams and external stakeholders. Ability to work as part of a team Proven ability to resolve complex technical issues efficiently. Significant knowledge of regulatory submission processes and guidelines, including FDA, EMA, ICH, and CTR requirements. Adaptability to work in a fast-paced, evolving regulatory environment. Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Show more Show less

Position Summary The Regulatory Administrator (RA) provides essential administrative and operational support to the Regulatory Affairs department to facilitate the regulatory submissions process. This role is critical to ensuring that regulatory documentation is accurate, compliant, and submitted in a timely manner to regulatory bodies such as the FDA, EMA, and other international authorities. The RA supports the department by managing regulatory submissions, organizing documentation, and ensuring compliance with relevant guidelines and regulations. Essential functions of the job include but are not limited to: Upload, organize, and maintain regulatory documents within applicable regulatory authority submissions portals (e.g. Clinical Trial Information System (CTIS), FDA eGateway, Common European Submissions Platform (CESP), etc.). Coordinate the redaction of confidential and proprietary information in regulatory documents, ensuring compliance with global standards. Liaise with external vendors for document redaction services and track the progress of redaction processes. Assist in preparing, formatting, and completeness checking documents for regulatory submissions (e.g., FDA, EMA, and other global regulatory authorities). Support the creation of regulatory submission packages, ensuring adherence to technical guidelines, as advised by Regulatory Manager Provide publishing and technical support for submission documents, including conversion to compliant formats (e.g., PDF, eCTD). Maintain current knowledge of evolving regulations and communicate updates to the Regulatory Affairs team. Maintain up-to-date tracking logs for submission timelines, regulatory approvals, and document status. Participate in department meetings to stay informed of regulatory updates, project timelines, and submission requirements. Ensure all activities are conducted in compliance with relevant regulatory guidelines and company policies. Qualifications Minimum Required: Bachelor’s degree, or equivalent experience, Computer literacy (MS Office/ Office 365) Fluent in English, both written and verbal. 1-2 years’ experience in document management Preferred Previous experience in clinical research, regulatory affairs, or a related field, particularly within a CRO, pharmaceutical, or biotech company. Familiarity with the CTIS system and experience submitting clinical trial applications under the Clinical Trial Regulation (CTR). Understanding of global regulatory requirements and guidelines, including FDA, EMA, and other regulatory bodies. Experience with document management systems (e.g., eTMF, Veeva Vault, MasterControl) and electronic submission formats (eCTD). Competencies Strong attention to detail and accuracy in handling regulatory documents. Excellent organizational and time management skills, with the ability to prioritize tasks and meet deadlines. Effective communication and interpersonal skills, capable of interacting with internal teams and external stakeholders. Ability to work as part of a team, with a proactive approach to problem-solving. Knowledge of regulatory submission processes and guidelines, including FDA, EMA, ICH, and CTR requirements. Adaptability to work in a fast-paced, evolving regulatory environment Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Show more Show less

Identify/implement process improvement initiatives using Lean,Six Sigma,Kaizen methodologies. Analyze performance metrics/lead root cause analysis (RCA)/corrective action plans. Collaborate cross-functionally to reduce waste/increase efficiency. Required Candidate profile 3--7 years of experience in a quality or process engineering role. Strong understanding of ISO 9001, IATF 16949, and APQP. Hands-on experience with quality tools (5 Why, Fishbone, SPC, MSA, etc.).

Position Summary: The Regulatory Administrator (RA) provides essential administrative and operational support to the Regulatory Affairs department to facilitate the regulatory submissions process. This role is critical to ensuring that regulatory documentation is accurate, compliant, and submitted in a timely manner to regulatory bodies such as the FDA, EMA, and other international authorities. The RA supports the department by managing regulatory submissions, organizing documentation, and ensuring compliance with relevant guidelines and regulations. Essential functions of the job include but are not limited to: Upload, organize, and maintain regulatory documents within applicable regulatory authority submissions portals (e.g. Clinical Trial Information System (CTIS), FDA eGateway, Common European Submissions Platform (CESP), etc.). Coordinate the redaction of confidential and proprietary information in regulatory documents, ensuring compliance with global standards. Liaise with external vendors for document redaction services and track the progress of redaction processes. Assist in preparing, formatting, and completeness checking documents for regulatory submissions (e.g., FDA, EMA, and other global regulatory authorities). Support the creation of regulatory submission packages, ensuring adherence to technical guidelines, as advised by Regulatory Manager Provide publishing and technical support for submission documents, including conversion to compliant formats (e.g., PDF, eCTD). Maintain current knowledge of evolving regulations and communicate updates to the Regulatory Affairs team. Maintain up-to-date tracking logs for submission timelines, regulatory approvals, and document status. Participate in department meetings to stay informed of regulatory updates, project timelines, and submission requirements. Ensure all activities are conducted in compliance with relevant regulatory guidelines and company policies. Qualifications: Minimum Required: Bachelor’s degree, or equivalent experience, Computer literacy (MS Office/ Office 365) Fluent in English, both written and verbal. 1-2 years’ experience in document management Preferred: Previous experience in clinical research, regulatory affairs, or a related field, particularly within a CRO, pharmaceutical, or biotech company. Familiarity with the CTIS system and experience submitting clinical trial applications under the Clinical Trial Regulation (CTR). Understanding of global regulatory requirements and guidelines, including FDA, EMA, and other regulatory bodies. Experience with document management systems (e.g., eTMF, Veeva Vault, MasterControl) and electronic submission formats (eCTD). Competencies Strong attention to detail and accuracy in handling regulatory documents. Excellent organizational and time management skills, with the ability to prioritize tasks and meet deadlines. Effective communication and interpersonal skills, capable of interacting with internal teams and external stakeholders. Ability to work as part of a team, with a proactive approach to problem-solving. Knowledge of regulatory submission processes and guidelines, including FDA, EMA, ICH, and CTR requirements. Adaptability to work in a fast-paced, evolving regulatory environment Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Show more Show less

Job Purpose: To ensure effective and timely management of product complaints by receiving, documenting, investigating, analyzing, and resolving product-related complaints in compliance with applicable regulatory requirements (e.g., ISO 13485, FDA 21 CFR Part 820, MDR). The role supports continuous improvement of product quality and customer satisfaction. Key Responsibilities: Receive and log product complaints from customers, sales team, or regulatory bodies in the complaint management system. Acknowledge receipt of complaints and communicate resolution timelines to complainants. Evaluate the complaint to determine if it qualifies as a reportable event per regulatory requirements. Coordinate with cross-functional teams (R&D, Quality, Manufacturing, etc.) to investigate root cause(s). Ensure timely and accurate completion of complaint investigations, CAPA initiation (if required), and closure within defined timelines. Document complaint details, investigation findings, corrective actions, and outcomes. Communicate findings and resolutions to stakeholders and customers. Generate monthly/quarterly complaint trend reports and risk assessments. Support external/internal audits and regulatory inspections by providing complaint-related documentation. Maintain compliance with company SOPs, ISO standards, and regulatory requirements. Recommend preventive actions and contribute to quality improvement initiatives. Required Qualifications and Skills: Bachelor’s degree in Pharmacy, Science, Biomedical Engineering, or equivalent field. 3+ years of experience in product complaint handling, preferably in the medical device or pharmaceutical industry. Knowledge of ISO 13485, FDA regulations, MDR, and other global regulatory requirements. Strong analytical, problem-solving, and documentation skills. Familiarity with complaint management software or QMS tools (e.g., TrackWise, MasterControl, etc.). Excellent communication skills – written and verbal. Attention to detail and a commitment to quality and compliance. Preferred Qualifications: Certification in Quality Management Systems or Regulatory Affairs. Experience in root cause analysis tools (e.g., 5 Whys, Fishbone, FMEA). Exposure to CAPA, NC, and audit handling processes. Show more Show less

Bangalore Karnataka India Job Type: Regular Full-time Division: Precision for Medicine Business Unit: Clinical Solutions Requisition Number: 5565 Position Summary: The Senior Regulatory Administrator (SRA) provides essential administration and operational support to the Regulatory Affairs department, overseeing the efficient management and maintenance of regulatory documents within the regulatory systems. This role is pivotal for ensuring that regulatory documentation is accurate, compliant, and submitted in a timely manner to regulatory bodies such as the FDA, EMA, and other international authorities. The SRA supports the department by managing the organization of regulatory documents for submissions, , ensuring compliance with relevant guidelines and regulations. The SRA involves in optimizing processes, mentor team members, and collaborating across departments to enhance our regulatory operational Essential functions of the job include but are not limited to: Upload, organize, and maintain regulatory documents within applicable regulatory authority submissions portals (e.g. Clinical Trial Information System (CTIS), FDA eGateway, Common European Submissions Platform (CESP), etc.). Coordinate the redaction of confidential and proprietary information in regulatory documents, ensuring compliance with global standards. Liaise with external vendors for document redaction services and track the progress of redaction processes. Assist in preparing, formatting, and completeness checking documents for regulatory submissions (e.g., FDA, EMA, and other global regulatory authorities). Support the creation of regulatory submission packages, ensuring adherence to technical guidelines, as advised by Regulatory Manager Provide publishing and technical support for submission documents, including conversion to compliant formats (e.g., PDF, eCTD). Assist under the guidance of Regulatory Manager in auditing and reviewing regulatory submissions for accuracy, completeness, and adherence to submission standards. Maintain current knowledge of evolving regulations and communicate updates to the Regulatory Affairs team. Maintain up-to-date tracking logs for submission timelines, regulatory approvals, and document status. Assist with internal audits and inspections by preparing required regulatory documentation and facilitating communication between stakeholders. Mentor, train and supervise junior Regulatory Administrators by providing guidance and support. Resolve complex issues related to submission document upload, publishing and system functionality. Contribute to planning and process improvement to enhance regulatory operation. Collaborate with cross functional teams. Participate in department meetings to stay informed of regulatory updates, project timelines, and submission requirements. Ensure all activities are conducted in compliance with relevant regulatory guidelines and company policies. Qualifications: Minimum Required: Bachelor’s degree, or equivalent experience, Computer literacy (MS Office/ Office 365) Fluent in English, both written and verbal. 3 years in document management Preferred: Previous experience in clinical research, regulatory affairs, or a related field, particularly within a CRO, pharmaceutical, or biotech company. Advanced knowledge of CTIS system and experience submitting clinical trial applications under the Clinical Trial Regulation (CTR). Previous Knowledge compiling and publishing, including eCTD. Understanding of global regulatory requirements and guidelines, including FDA, EMA, and other regulatory bodies. Experience with document management systems (e.g., eTMF, Veeva Vault, MasterControl) and electronic submission formats (eCTD). Competencies Strong attention to detail and accuracy in handling regulatory documents. Excellent organizational and time management skills, with the ability to prioritize tasks and meet deadlines. Excellent communication and interpersonal skills, capable of interacting with internal teams and external stakeholders. Ability to work as part of a team Proven ability to resolve complex technical issues efficiently. Significant knowledge of regulatory submission processes and guidelines, including FDA, EMA, ICH, and CTR requirements. Adaptability to work in a fast-paced, evolving regulatory environment. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Any data provided as a part of this application will be stored in accordance with our Privacy Policy. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2021 Precision Medicine Group, LLC. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.

Bangalore Karnataka India Job Type: Regular Full-time Division: Precision for Medicine Business Unit: Clinical Solutions Requisition Number: 5566 Position Summary: The Regulatory Administrator (RA) provides essential administrative and operational support to the Regulatory Affairs department to facilitate the regulatory submissions process. This role is critical to ensuring that regulatory documentation is accurate, compliant, and submitted in a timely manner to regulatory bodies such as the FDA, EMA, and other international authorities. The RA supports the department by managing regulatory submissions, organizing documentation, and ensuring compliance with relevant guidelines and regulations. Essential functions of the job include but are not limited to: Upload, organize, and maintain regulatory documents within applicable regulatory authority submissions portals (e.g. Clinical Trial Information System (CTIS), FDA eGateway, Common European Submissions Platform (CESP), etc.). Coordinate the redaction of confidential and proprietary information in regulatory documents, ensuring compliance with global standards. Liaise with external vendors for document redaction services and track the progress of redaction processes. Assist in preparing, formatting, and completeness checking documents for regulatory submissions (e.g., FDA, EMA, and other global regulatory authorities). Support the creation of regulatory submission packages, ensuring adherence to technical guidelines, as advised by Regulatory Manager Provide publishing and technical support for submission documents, including conversion to compliant formats (e.g., PDF, eCTD). Maintain current knowledge of evolving regulations and communicate updates to the Regulatory Affairs team. Maintain up-to-date tracking logs for submission timelines, regulatory approvals, and document status. Participate in department meetings to stay informed of regulatory updates, project timelines, and submission requirements. Ensure all activities are conducted in compliance with relevant regulatory guidelines and company policies. Qualifications: Minimum Required: Bachelor’s degree, or equivalent experience, Computer literacy (MS Office/ Office 365) Fluent in English, both written and verbal. 1-2 years’ experience in document management Preferred: Previous experience in clinical research, regulatory affairs, or a related field, particularly within a CRO, pharmaceutical, or biotech company. Familiarity with the CTIS system and experience submitting clinical trial applications under the Clinical Trial Regulation (CTR). Understanding of global regulatory requirements and guidelines, including FDA, EMA, and other regulatory bodies. Experience with document management systems (e.g., eTMF, Veeva Vault, MasterControl) and electronic submission formats (eCTD). Competencies Strong attention to detail and accuracy in handling regulatory documents. Excellent organizational and time management skills, with the ability to prioritize tasks and meet deadlines. Effective communication and interpersonal skills, capable of interacting with internal teams and external stakeholders. Ability to work as part of a team, with a proactive approach to problem-solving. Knowledge of regulatory submission processes and guidelines, including FDA, EMA, ICH, and CTR requirements. Adaptability to work in a fast-paced, evolving regulatory environment It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Any data provided as a part of this application will be stored in accordance with our Privacy Policy. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2021 Precision Medicine Group, LLC. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.

Responsibilities: a) Provide L1 & L2 technical support for QUMAS users, resolving system issues, access problems, and workflow errors. b) Troubleshoot performance issues, integration errors, and system security vulnerabilities related to QUMAS. c) Work with IT teams to resolve server, database, and network-related issues affecting QUMAS functionality. d) Monitor QUMAS performance, uptime, and security to ensure system reliability. e) Perform software updates, patches, and system configurations as needed. f) Manage user accounts, roles, and access permissions following security and compliance guidelines. g) Monitor electronic signatures, audit trails, and data integrity within the QMS platform. h) Address user inquiries, service requests, and tickets through IT helpdesk systems i) Collaborate with vendors and developers to resolve system bugs and enhance functionalities. Experience: a) Proven experience working with QUMAS or other quality management systems (e.g., MasterControl, Veeva Vault QMS), QUMAS DocCompliance, ProcessCompliance, and Training modules. b) Previous experience in a GxP-compliant environment is highly preferred. c) Experience with document processes, workflows, and standard operating procedures (SOPs) within the QMS platform. d) Experience with generating and analysing reports related to quality management performance, system usage, and compliance status. Skills: a) Strong understanding of document control, regulatory compliance, CAPA, risk management, and workflow automation. b) Experience with SQL databases, Windows/Linux servers, and enterprise system integrations. c) Basic scripting knowledge (PowerShell, Python) is a plus. b) Familiarity with document management systems (DMS) and quality management software. c) Excellent problem-solving skills and ability to troubleshoot technical issues. d) Strong communication and training skills. e) Ability to work both independently and collaboratively with cross-functional teams. Show more Show less

Position Summary: The Regulatory Administrator (RA) provides essential administrative and operational support to the Regulatory Affairs department to facilitate the regulatory submissions process. This role is critical to ensuring that regulatory documentation is accurate, compliant, and submitted in a timely manner to regulatory bodies such as the FDA, EMA, and other international authorities. The RA supports the department by managing regulatory submissions, organizing documentation, and ensuring compliance with relevant guidelines and regulations. Essential functions of the job include but are not limited to: Upload, organize, and maintain regulatory documents within applicable regulatory authority submissions portals (e.g. Clinical Trial Information System (CTIS), FDA eGateway, Common European Submissions Platform (CESP), etc.). Coordinate the redaction of confidential and proprietary information in regulatory documents, ensuring compliance with global standards. Liaise with external vendors for document redaction services and track the progress of redaction processes. Assist in preparing, formatting, and completeness checking documents for regulatory submissions (e.g., FDA, EMA, and other global regulatory authorities). Support the creation of regulatory submission packages, ensuring adherence to technical guidelines, as advised by Regulatory Manager Provide publishing and technical support for submission documents, including conversion to compliant formats (e.g., PDF, eCTD). Maintain current knowledge of evolving regulations and communicate updates to the Regulatory Affairs team. Maintain up-to-date tracking logs for submission timelines, regulatory approvals, and document status. Participate in department meetings to stay informed of regulatory updates, project timelines, and submission requirements. Ensure all activities are conducted in compliance with relevant regulatory guidelines and company policies. Qualifications: Minimum Required: Bachelor's degree, or equivalent experience, Computer literacy (MS Office/ Office 365) Fluent in English, both written and verbal. 1-2 years' experience in document management Preferred: Previous experience in clinical research, regulatory affairs, or a related field, particularly within a CRO, pharmaceutical, or biotech company. Familiarity with the CTIS system and experience submitting clinical trial applications under the Clinical Trial Regulation (CTR). Understanding of global regulatory requirements and guidelines, including FDA, EMA, and other regulatory bodies. Experience with document management systems (e.g., eTMF, Veeva Vault, MasterControl) and electronic submission formats (eCTD). Competencies Strong attention to detail and accuracy in handling regulatory documents. Excellent organizational and time management skills, with the ability to prioritize tasks and meet deadlines. Effective communication and interpersonal skills, capable of interacting with internal teams and external stakeholders. Ability to work as part of a team, with a proactive approach to problem-solving. Knowledge of regulatory submission processes and guidelines, including FDA, EMA, ICH, and CTR requirements. Adaptability to work in a fast-paced, evolving regulatory environment Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Position Summary: The Regulatory Administrator (RA) provides essential administrative and operational support to the Regulatory Affairs department to facilitate the regulatory submissions process. This role is critical to ensuring that regulatory documentation is accurate, compliant, and submitted in a timely manner to regulatory bodies such as the FDA, EMA, and other international authorities. The RA supports the department by managing regulatory submissions, organizing documentation, and ensuring compliance with relevant guidelines and regulations. Essential functions of the job include but are not limited to: Upload, organize, and maintain regulatory documents within applicable regulatory authority submissions portals (e.g. Clinical Trial Information System (CTIS), FDA eGateway, Common European Submissions Platform (CESP), etc.). Coordinate the redaction of confidential and proprietary information in regulatory documents, ensuring compliance with global standards. Liaise with external vendors for document redaction services and track the progress of redaction processes. Assist in preparing, formatting, and completeness checking documents for regulatory submissions (e.g., FDA, EMA, and other global regulatory authorities). Support the creation of regulatory submission packages, ensuring adherence to technical guidelines, as advised by Regulatory Manager Provide publishing and technical support for submission documents, including conversion to compliant formats (e.g., PDF, eCTD). Maintain current knowledge of evolving regulations and communicate updates to the Regulatory Affairs team. Maintain up-to-date tracking logs for submission timelines, regulatory approvals, and document status. Participate in department meetings to stay informed of regulatory updates, project timelines, and submission requirements. Ensure all activities are conducted in compliance with relevant regulatory guidelines and company policies. Qualifications: Minimum Required: Bachelor's degree, or equivalent experience, Computer literacy (MS Office/ Office 365) Fluent in English, both written and verbal. 1-2 years' experience in document management Preferred: Previous experience in clinical research, regulatory affairs, or a related field, particularly within a CRO, pharmaceutical, or biotech company. Familiarity with the CTIS system and experience submitting clinical trial applications under the Clinical Trial Regulation (CTR). Understanding of global regulatory requirements and guidelines, including FDA, EMA, and other regulatory bodies. Experience with document management systems (e.g., eTMF, Veeva Vault, MasterControl) and electronic submission formats (eCTD). Competencies Strong attention to detail and accuracy in handling regulatory documents. Excellent organizational and time management skills, with the ability to prioritize tasks and meet deadlines. Effective communication and interpersonal skills, capable of interacting with internal teams and external stakeholders. Ability to work as part of a team, with a proactive approach to problem-solving. Knowledge of regulatory submission processes and guidelines, including FDA, EMA, ICH, and CTR requirements. Adaptability to work in a fast-paced, evolving regulatory environment Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.