ResponsibilitiesEngage with Medical Experts (MEs) to educate on medical/scientific information -Ensure appropriate identification/mapping of MEs/ Key Accounts including identification of opportunities to involve MEs when a specific medical need is identified to provide support -Develop and execute ME engagement plans to effectively prioritize and strategically engage MEs aligned with country strategy .Respond to unsolicited requests for information from MEs -Support Novartis clinical research programs, optimize trial execution and provide scientific educational support to potential and actual study sites in collaboration with clinical operations.Facilitate Investigator Initiated Trial (IIT) process upon investigator request -Serve as a medical resource to field matrix colleagues -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)Qualification & Experience      Works within Ethics and Compliance policies -Achievement of annual targets for medical activities.Desirable Requirements:  Operations Management and Execution.Collaborating across boundaries.Skills:Biostatistics.Clinical Practices.Clinical Research.Clinical Study Reports.Curiosity.Customer Relationship Management (CRM) Software.Disease Management.Drug Development.Education.Epidemiology.IT Tools.Medical Information.Medical Research.Medical Writing.Phase Iv Clinical Trial.Product Placement.Scientific Support.

ResponsibilitiesSupport the site and customer related regulatory dossier activities for clinical trial and license applications. Write CMC regulatory dossiers using source documents, ensuring accuracy, completeness, and compliance. Support product lifecycle management activities. Manage regulatory workflows, trackers, and document systems (e.g., Veeva) to ensure timely and controlled submissions. Collaborate with Lonza network Regulatory teams to co-ordinate the regulatory submissions to achieve successful submission outcomes. Qualification & ExpeirenceDegree in Chemistry, Biology, or related Life Sciences discipline Strong knowledge of global regulatory requirements and CMC documentation (clinical and commercial submissions). Experience with Veeva Vault, eCTD publishing, and document management systems.Strong project management skills with the ability to manage multiple priorities and timelines. Excellent communication skills with business fluency in English and ability to influence stakeholders. Collaborative, proactive, and solution-oriented mindset with strong accountability and ownership.

ResponsibilitiesCommissioning & Qualification Lifecycle: Review and approve reports, protocols, and test documentation for commissioning and qualification of facilities, utilities, computerized systems, equipment, and laboratories in line with Lonza standards and regulatory expectations. GMP Design Review: Support the review of GMP design deliverables (flows, zoning, layouts) to ensure compliance. Deviation Management: Ensure discrepancies or deviations related to facilities and utilities are assessed, documented, traceable, and resolved. Periodic Requalification & Validation Maintenance: Review and approve periodic requalification documentation (e.g., freezers, autoclaves, HVAC, biosafety cabinets, cold rooms). Confirm validated state through validation maintenance reports. Review and approve decommissioning documentation as applicable. Quality & Risk Management: Review and support management of quality records (deviations, CAPA, change controls, investigations, product quality review). Maintain high standards of GMP compliance, documentation quality, and technical accuracy. Audit Readiness: Promote and maintain a state of audit readiness across qualification activities. Timely Delivery: Ensure assigned work is delivered within agreed timelines, proactively identifying and escalating risks or delays. Continuous Improvement: Contribute to process improvement initiatives and support implementation of new tools or approaches. Other Duties: Perform additional quality and compliance tasks as assigned. Education & Experience Qualification & ExperienceBachelor’s degree in Chemistry, Biochemistry, Pharmacy, or related scientific field. Minimum 5 years of relevant experience in regulated pharmaceutical industry (engineering, manufacturing, QA, QC). Experience in commissioning, qualification, and validation of manufacturing equipment, facilities, utilities, support systems, laboratory equipment, and computerized systems. Experience in process or cleaning validation beneficial. Proven experience in EMA/FDA regulated environments with strong knowledge of ICH, PIC/S, EU, and US regulatory requirements. Experience in chemical and biological GMP API manufacturing with ability to interpret and implement quality and regulatory requirements. Knowledge of CQV approaches and electronic validation tools (e.g., Kneat Gx).

ResponsibilitiesTranslate technical, operational, and organizational documents across various departments (Quality, Production, Engineering, HR, and Communication) with accuracy, consistency, and in accordance with internal standards. Ensure linguistic quality, clarity, and alignment with site terminology and regulatory expectations. Maintain documentation alignment with approved templates, controlled language, and quality system requirements. Act as the Subject Matter Expert (SME) for translation workflows and tools, supporting teams in the preparation, wording, and structure of documents. Guarantee the timely delivery of translations, proactively managing workload and shifting priorities to meet critical site due dates. Review, edit, and proofread translated content to ensure absolute correctness and compliance. Collaborate closely with team members and Operations to define priorities, secure customer satisfaction, and guarantee readiness for documentation implementation.Qualification & ExpeirenceDegree in Translation, Linguistics, or a related field; or equivalent professional experience in technical translation. Proven experience translating technical documentation, ideally within a pharmaceutical, chemical, or highly regulated GxP environment. Excellent command of German and English (written and spoken) is essential, with the ability to capture complex technical nuances in both languages. Strong attention to detail and a commitment to maintaining consistency across large volumes of documentation.

ResponsibilitiesMonitoringofDP,RHandtemperatureintheirComponentpreparationandsterilizationarea(Autoclave area). ResponsibleforMaintenanceandcleaningofComponentpreparationandsterilizationarea(Autoclave area). TomaintaintheBMRsandotherlogbooksintheComponentpreparationandsterilizationarea (Autoclave area) as per cGMP and SOP. OperationandcleaningofdynamicpassboxinComponentpreparationandsterilizationarea(Autoclave area). CleaningandsanitizationofdrainpointsinComponentpreparationandsterilizationarea(Autoclave area). Preparation,filtrationandissuanceofdisinfectantanddeactivationsolutionstoallthesectionsinthe production area. Operation and cleaning of glove and filters integrity testers Responsible for cleaning and storage of all the filling machine accessories and change parts. Operation and cleaning of table mounted LAF and Ceiling mounted LAF. Operation and cleaning of steam sterilizer and HPHV steam sterilizer. PreparationofloadsmeantforAutoclavinglikegarments,disinfectant,filling,filtration,rubberstopperand seals for sterilization as per the validated load pattern. Responsiblefortheco-ordinationwithcrossfunctionaldepartmentslikeQA,QC,warehouseEngineering, HR and administration for the day to day activities. ResponsiblefortimelycompletionofcalibrationsandvalidationsincoordinationwithEng.andQArelated to Component preparation and sterilization area (Autoclave area). TimelycompletionofSOPstrainingandonthejobtrainingsrelatedtoComponentpreparationand sterilization area (Autoclave area).

Responsibilities Ensure all engineering activities are executed in compliance with cGMP, GEP, and site SOPs.  Ensure compliance with Quality Management Systems (QMS) and applicable regulatory guidelines.  Handle all quality documents related to engineering such as Change Controls, Deviations, CAPA, and Quality Risk Management.  Review and update the respective planner and ensure compliance of activity on time.  Prepare and revise SOPs for plant machinery, utilities, HVAC, and water systems.  Support preventive maintenance execution as per the defined PM schedule and SOPs.  Assist engineers in installation and commissioning of new equipment.  Ensure effectiveness of training through review, feedback, and improvement initiatives.  Draft and update Job Descriptions for department personnel based on roles and responsibilities. Act as the Training Coordinator for the Maintenance Department.  Update classroom/adhoc training records in training software.  Generate re-training requirements for SOP changes or compliance gaps.  Prepare, review, and revise training matrices as per SOP changes or department needs.  Identify and update training needs (TNI) and ensure compliance with training requirements.  Manage user creation/inactivation and credential sharing in AIMS software or equivalent systems.  Ensure new joiners are trained according to function mapping and training plan.  Upload training materials (new/revised SOP copies) and track completion.  Attend scheduled trainings and ensure personal and departmental training compliance.

Responsibilities Manage, control, and maintain all Quality Assurance (QA) documents, records, and logs in compliance with GMP requirements.  Ensure timely issuance, retrieval, archival, and destruction of controlled documents according to approved procedures.  Maintain document revision history and ensure only current, approved versions are available for use.  Coordinate document review, approval, and distribution processes with QA, Production, QC, and other departments.  Monitor compliance with document control procedures and support internal audits and regulatory inspections.  Maintain electronic and physical document management systems, ensuring data integrity and confidentiality.  Track periodic review schedules for Standard Operating Procedures (SOPs), specifications, forms, and quality manuals.  Support change control activities by updating and distributing revised documents as per approved changes.  Prepare document control metrics, reports, and status updates for management review. Qualification & ExperienceB. Pharm B. Pharm - Required M. Pharm M. Pharm - Preferred Experience: 2 years or more in 2 - 5 Years

ResponsibilitiesThis role is responsible for processing the Regulatory Support Request, ad-hoc activities assigned to the Regulatory Support Team, receive training and become process expert. Closely work the pending requests and provide support for early resolution. Achieve SLA, increase NPS Scores & First Pass Yield and reduce AHT. All ad hoc request needs to be reviewed and attended within the timeline. Manage for process updates and process document maintenance for ticketing requests. Qualification & ExperienceEducation: Bachelor´s degree or equivalent experience in Computer Science or related subject preferred. Experience: At least 5 years of experience in regulatory or customer service experience role. This role will be based in Pune and will be 3 days working from office in Hybrid mode. Shift Timing (12:30 PM – 9:30 PM IST) Monday to Friday. 5+ years of experience as a regulatory or customer service experience role. Strong skills in Microsoft excel. Knowledge and experience with Windchill, Rimsys & Syndigo is plus.

ResponsibilitiiesValidate, maintain, and manage regulatory data for medicinal products in compliance with EMA guidelines. Perform xEVMPD submissions via EMA Gateway and monitor acknowledgements using Register/AgXchange, EV Web, and Veeva Vault. Support Product Lifecycle Management (PLM) activities, including variations, renewals, and regulatory updates for CAPs and non-CAPs. Execute Post-Marketing Surveillance (PMS) and Product Update Information (PUI) activities, ensuring timely and accurate submissions. Prepare and manage EMA deliverables such as eAF (electronic Application Forms) and eSMP (electronic Summary of Product Characteristics). Handle submission and maintenance of regulatory documents including SmPC, PIL, and Health Authority communications. Work on regulatory procedures such as xEVMPD, IDMP, CTA, MAA, and lifecycle management activities. Utilize Veeva Vault RIM for submissions, tracking, and regulatory data management. Ensure accurate data aggregation, mapping, and consistency across multiple regulatory systems and documents (RIMS, DMS). Collaborate with cross-functional teams to ensure compliance and timely regulatory submissions.Qualification & ExperienceBachelor’s or Master’s degree in Life Sciences, Pharmacy, or related field. Proven experience in Regulatory Affairs with focus on EMA submissions and xEVMPD. Hands-on experience with Veeva Vault RIM and regulatory submission tools. Strong knowledge of EU regulatory processes (CTA, MAA, IDMP, lifecycle management). Familiarity with regulatory systems such as RIMS and DMS. Proficiency in Microsoft 365 tools (Excel, Teams, SharePoint). Strong analytical skills with ability to collect, interpret, and map complex data. High attention to detail and strong organizational skills. Effective communication and teamwork abilities.

ResponsibilitiiesEnsure oversight on key processes and ensure framework is in place to manage third-party activities E2E ensuring compliance with regulations and company standards; monitor partner performance against agreed-upon metrics and standards, addressing any deviations or deficiencies promptly. Conduct periodic assessments of partners to ensure compliance with local requirements and quality standards, implement corrective actions as necessary; develop risk mitigation strategies and implement controls to minimize risks associated with partner activities. Act as point of contact for escalations and issue resolution related to partner activities. Stay updated on local regulatory requirements, guidelines, and industry trends to ensure compliance with evolving regulations and communicate to GRA and local team; participating in policy activities with industry groups and trade associations. Support regional regulatory TA teams within GRA, for efficient planning and submission preparation according to local requirements and business needs. Keep internal databases up to date with local activity and ensure compliance KPIs are adequately kept on track. Act as primary interface with local partners representing the company's regulatory interests and fostering positive relationships and ensure that partner, who is acting on CSL behalf, has the appropriate interactions with Has. Monitor training effectiveness and compliance, ensure proper trainings are developed and in place, providing support and resources as needed to address gaps and improve performance.Qualification & ExperienceIdeally 5+ years of experience in Regulatory Affairs, oversight, governance or compliance roles within pharmaceutical, biotechnology or healthcare industry. Partner management experience: proven experience in managing relationships with third-party vendors. Ability to work in a highly matrixed organization and to establish successful cross-functional working relationships with people in a wide variety of disciplines and backgrounds, be interpersonally aware and culturally sensitive.