Responsibilities Validate, 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.Qualification & Experience Bachelor’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).

ResponsibilitiesArtwork Management (all components) Understanding and operational efficiency of artwork management system.  Artwork requests to be raised with India specific annotations.  Comments received from overseas sites to be addressed and post peer review, approve final artwork files as per artwork approval checklist. Coordination with packaging coordinator, supply chain, BU/ Pricing / Legal team wherever required.  Support for QR code / serialization implementation as per business and regulatory needs.  Review and impact assessment of new India regulations relevant to labels if any. Ensure implementation as per timelines in coordination with local/ global stakeholders.  Support artwork developed for local partners as applicable.  Support labels of neighbouring markets e.g. Nepal as needed.  Prepare for audit of labeling activity if any and implement CAPAs if applicable.  Liaison closely with overseas manufacturing site for labels of 1st launch batch, exploring innovative options for early launch.  Ensure 100?herence to internal and external labelling requirements. Internal customers Marketing, Logistics, Medical, Legal Affairs Intellectual Property, Global Product Teams (GPTs), Key Brand Teams (KBTs), International Regulatory Affairs (IRA), Manufacturing Sites and QA External customers Local Health Authorities and other Government Agencies Qualification & ExpeirenceB. Pharm/ M. Sc 3-6 yrs Experience in India Artwork requirement and knowledge of D&C act for Artwork checklist. Should be conversant with Indian regulations in Artwork development.

ResponsibilitiesPreparation and submission of dossiers for EMB, country-specific dossiers, CTD, ACTDand eCTD. Responsible for assigned products - Master dossier upgradation. Query response preparation and submission in emerging market Co-ordination with BD team, country manager and international regulatory agencies forregistration of products for emerging market Post-approval change application for the approved products in emerging market forcommercial support Supporting global filing, and preparation of briefing packages. Supporting in routine activities like artwork management, incoming document review, Gapanalysis. Business development support etc. Supporting Domestic activities like preparation, review and submission to CDSCO/ FDCA Post-approval change application for the approved products Regulatory knowledge sharing: Read and share new regulatory guidelines, trends, expectations and compliance documents. Do impact analysis with internal product development strategies. Acquire knowledge of the activities in new territories and keep upto date with current requirements. Interact, develop and maintain relationships with regulatory / drug control authorities /government agencies and other external regulatory experts.

ResponsibilitiesAuthor or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, Pediatric Investigation Plans, and other regulatory documents; Conduct the formal review and approval of authored documents, following applicable standard operating procedures; With limited supervision, lead regulatory writing activities for complex product submissions, including new and supplemental drug applications/biologics license applications; Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group)  Provide functional area input for Global Regulatory Plan and team goals  oversee the work of contract and freelance writers train, mentor, or supervise more junior medical writers, as assigned  lead departmental and cross-departmental initiatives, as appropriate Generate document timeline and keep abreast of relevant professional information and technologyQualification & ExperienceDoctorate degree and 2 years of directly related experience OR Master’s degree and 6 years of directly related experience

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).

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.

ResponsibilitiesStrong knowledge of USFDA, ICH guidelines, regional regulations (US, EU, India), and submission formats. Prepare, compile, and submit regulatory dossiers (e.g., CTD/eCTD) for new drug applications (NDAs), ANDAs, MAAs, and post-approval changes Support regulatory strategy development for new products and markets Coordinate with cross-functional teams (CDMO, R&D, Manufacturing) to gather required documentation and data. Respond to queries and deficiency letters from regulatory authorities Maintain regulatory databases and track submission timelines and approvalsQualification & ExperienceGraduate : M.Pharm Experience Tenure : 2- 5 years of relevant experience