We are seeking a highly skilled and motivated Laboratory Information Management System (LIMS) Manager to become an integral part of our vibrant team in Bangalore, India. The LIMS Manager will be responsible for overseeing the daily operations of our LIMS, focusing on logistics, sample planning, and ensuring efficient laboratory workflows. Key Responsibilities: Manage, maintain, and troubleshoot the Laboratory Information Management System (LIMS) to ensure seamless operation. Manage the day-to-day operations of the LIMS, ensuring seamless integration with laboratory workflows. Coordinate sample planning and logistics to optimize laboratory efficiency. Ensure accurate and timely data entry and management within the LIMS. Provide training and support to laboratory personnel on LIMS functionalities and best practices. Monitor system performance and troubleshoot issues to ensure optimal functionality. Generate and analyze reports to support research and development activities. Maintain compliance with regulatory standards and internal policies. Leverage Power BI and Power Query to design and implement interactive dashboards and visualizations for data-driven decision-making. Provide user support and training to lab personnel and stakeholders on IT tools and custom-built solutions. Qualifications & Requirements: Bachelors degree in a relevant field (e.g., Life Sciences, Chemistry, Information Management). Experience in managing LIMS in a pharmaceutical or analytical research environment. Experience working with Power BI, Power Query and advanced formulas in Excel Strong understanding of laboratory workflows and sample logistics. Excellent problem-solving skills and attention to detail. Effective communication and interpersonal skills. Ability to work collaboratively in a fast-paced, team-oriented environment. What we offer: An inspiring challenge to work with great co-workers on ambitious projects that change peoples lives. The chance to be part of a global and fast-growing company. An international work culture that encourages diversity, collaboration, and inclusion. Positive, flexible, and innovative work environment. A clear and developed organizational structure. Training and global opportunities to advance. A good work-life balance. Home internet and home office equipment.

Alvotech is looking to hire a Manager for Global Regulatory Affairs Life-Cycle Management (LCM) Chemistry, Manufacturing, and Controls (CMC). In this role, you will support life-cycle management of biosimilar products by developing regulatory strategies, representing the CMC regulatory team in cross-departmental projects, and ensuring unified regulatory advice. You will also identify and mitigate regulatory risks, manage high-quality documentation, participate in health authority interactions, and collaborate with external partners. Key Responsibilities: Assist in developing regulatory LCM CMC strategies. Represent CMC regulatory team in cross-functional teams. Communicate unified GRA-aligned messages at interdisciplinary meetings. Identify and mitigate product CMC regulatory risks. Assess and approve change controls for responsible products. Review and manage high-quality CMC documentation. Understand and apply ICH, FDA guidelines, GMP, and quality requirements. Participate in health authority interactions. Interface with external partners to support commercial success. Support development of regulatory excellence tools and processes. Ensure efficient and transparent working environment within GRA. Keep projects on track and within budget. Job Requirements: PhD (1-3 years), MS (4-6 years), BS (6-8 years) in relevant functions in the Pharmaceutical/Biotechnology Industry, or equivalent. Subject matter expertise in regulatory affairs and related activities. Previous experience in life cycle management and variation filing for US, EU. Ability to work in matrix teams and diverse cultures. Ability to work effectively in a fast-paced dynamic environment. Fluency in English is essential; other languages are beneficial.

Obtain and manage CMC-related documents for regulatory submissions. Ensure compliance with ICH, FDA, EMA, WHO, and other regulatory guidelines. Collaborate with internal teams and CMOs to prepare high-quality regulatory sections. Lead responses to CMC-related questions from regulatory authorities. Establish strategies for document authoring and quality. Implement industry standards for regulatory submissions. Communicate unified regulatory messages at interdisciplinary meetings. Identify and mitigate regulatory CMC risks. Promote continuous improvement within regulatory compliance. Ensure efficient and transparent working environment within GRA. Other tasks as required by senior management. Job Requirements: Bachelor s or master s degree in biotechnology, Life Sciences. 5+ years direct industry experience in Regulatory CMC Biologics, 10+ years industry-relevant experience. Hands-on experience with EMA/FDA/PMDA/Health Canada CTD requirements. Proven ability to produce high-quality CMC documentation for complex large molecules. Knowledge of CMC expectations at all stages of product development. Experience with post-market activities in the LCM space preferred. Strong communication and interpersonal skills. Ability to work independently and prioritize tasks effectively. Proficiency in English, written and spoken. What we offer: An inspiring challenge to work with great co-workers on ambitious projects that change peoples lives. The chance to be part of a global and fast-growing company. An international work culture that encourages diversity, collaboration, and inclusion. Positive, flexible, and innovative work environment. A clear and developed organizational structure. Training and global opportunities to advance. A good work-life balance. Home internet and home office equipment.

At Alvotech, our Global Regulatory Affairs (GRA) team is dedicated to bridging the gap between science and worldwide regulatory authorities to deliver affordable biosimilar medicines. We are looking to hire an experienced Regulatory Manager to support Global Regulatory Leads (GRLs) in all aspects of Global regulatory product development strategy. This is a unique opportunity to work directly on EU, US and Japan regulatory submissions and gain true global experience working in dynamic teams. Key Responsibilities: Support GRLs in overseeing regulatory strategic aspects for development and post-approval activities. Compile and prepare high-quality regulatory documentation for global submissions (INDs, MAAs, BLAs, briefing books, responses to questions, etc.). Assist in developing worldwide regulatory strategies for biosimilar products. Represent GRA Strategy in cross-departmental teams, providing unified regulatory advice and project status updates. Ensure a single, aligned GRA message at interdisciplinary meetings. Identify regulatory risks and propose mitigation strategies. Apply knowledge of ICH and Global Regulatory guidelines, GMP, and quality requirements. Participate in health authority interactions and responses. Interface with external partners and cross-functional teams to ensure global dossier alignment and support commercial success. Perform activities to keep assigned projects on track. Engage in continuous professional development to stay updated on new regulatory requirements and technical developments. Job Requirements: BSc (or equivalent) in biological or healthcare science + 5 years in relevant functions in the Pharmaceutical/Biotechnology Industry, or equivalent. Extensive experience in Regulatory Affairs with expertise in biologics for US and EU markets. Strong regulatory authoring skills and willingness to support key regulatory documents. Expertise in global dossier authoring for biologics/biosimilars (EMA/FDA). Direct experience managing MAA/BLA approvals. Fluency in English with strong communication skills. Ability to work collaboratively across diverse teams. Ability to work effectively in a fast-paced dynamic environment. Excellent multitasking and attention to detail. What we offer: An inspiring challenge to work with great co-workers on ambitious projects that change peoples lives. The chance to be part of a global and fast-growing company. An international work culture that encourages diversity, collaboration, and inclusion. Positive, flexible, and innovative work environment. A clear and developed organizational structure. Training and global opportunities to advance. A good work-life balance. Home internet and home office equipment.

Alvotech is looking to hire a Clinical Development Lead who will play a pivotal role in the strategic planning and preparation of Clinical Development Plans (CDP) for assigned clinical programs. As a clinical expert, this role supports Clinical and Medical Affairs Group in interactions with external stakeholders such as regulatory authorities, key opinion leaders, data monitoring boards, and advisory boards, as well as internal stakeholders including CMA, GRA, and Device Development. The Clinical Development Lead is responsible for ensuring state-of-the-art scientific input into all relevant clinical and regulatory documents for assigned projects. Additionally, this role involves thorough review, interpretation, and presentation of clinical trial data for further discussions, both internally and externally, in collaboration with Medical Leads. Scope & Responsibilities: Lead preparation and review of clinical documents (protocol synopses, protocols, clinical trial reports, IMPD sections, IB). Ensure scientific excellence in clinical development strategy, trial designs, and regulatory documents. Lead the preparation of Clinical Development Plans (CDP). Provide high-level scientific input for safety reports, briefing documents, INDs, NDAs, and other regulatory submissions. Offer clinical/scientific input during clinical trial development and execution, including data review activities. Contribute to study documents (e.g. SAP, DMP). Interpret clinical trial data. Lead interactions with regulatory authorities for clinical development discussions. Participate in or provide input for independent monitoring committee meetings. Maintain up-to-date training records. Stay current with ICH-GCP requirements. Job Requirements: Education : Minimum Master s degree in life sciences or equivalent. M.D., Pharm.D., Ph.D. strongly desired. Experience : 5+ years in relevant roles within the Pharmaceutical Industry. Scientific Background : Strong background in pharmacology, immunology and/or oncology preferred. Biosimilars/Biologicals Experience : Prior experience with biosimilars or biologicals essential. Language Skills: Fluent in English (written and verbal). Additional languages are a plus. Leadership and Interpersonal Skills : Strong leadership, participation, and team contribution skills, with the ability to build team spirit, communicate openly, and share knowledge. GCP Knowledge : Deep understanding of GCP and GxP. Technical Skills : Proficient with Microsoft Office (Word, Visio, Excel, PowerPoint). What we offer: An inspiring challenge to work with great co-workers on ambitious projects that change peoples lives. The chance to be part of a global and fast-growing company. An international work culture that encourages diversity, collaboration, and inclusion. Positive, flexible, and innovative work environment. A clear and developed organizational structure. Training and global opportunities to advance. A good work-life balance. Home internet and home office equipment.