Scope of the responsibility lies within Chemistry PMOps Business support PURPOSE OF THE POSITION: Senior Analyst supports Product Managers, Marketing Managers and Project Managers in execution of tasks related to Product Life Cycle Management/New Product Introduction by collaborating with Cross-functional teams using various systems for Chemistry Business Responsibilities: Act as a primary interface with Operational Organizations [Manufacturing, Purchasing, Tech Service, QA, etc] Supports Product Life Cycle Management / New Product Introduction activities through SAP & Web Data Maintenance using various tools Review NPDI completeness, Master data completeness and correctness Review Corpbase data compilation and data cleansing Trouble shoot WEB PDP data Create and maintain appropriate documents and tracking systems for existing products update (ie, product numbers, technical bulletins/product information sheet review, certificate of analysis, certificate of origin, specification review, create product listing on the website) Generate Business warehouse and other Sales reports needed by Marketing Staff, and other routine sales reports Review and track product inventory/backorder status Meeting the SLA and TAT as per the agreed guidelines with the Stakeholders Accountable for meeting and maintaining defined standards for quality and productivity Ensure that internal and external customers requirements are met on timely basis Demonstrate good process knowledge within the process on all the activities Assist Specialist with ISO and other additional activity to support Support the team with process improvement ideas and necessary trainings This position has no supervisory responsibility nor require any Business Travel BASIC QUALIFICATIONS:Who you are: Education: Postgraduate in Life Sciences (Chemistry/Biochemistry) from a reputed University Experience: 3-5 Years in Scientific Industry Technical Skills / Competencies: Scientific Knowledge Intermediary proficiency and functional command expected over Life science subject Understanding of roles and responsibilities of Business Operations Intermediary proficiency with internet and e-mail Very good skills in Office 365 tools (Excel, Teams, Outlook, Sharepoint) and ability to set up complex database queries Very good skills in Data analytics tools (Power BI, Tableau, Python, Palantir) and ability to build business reports and dashboards Navigate different t-codes in PRD, PRE, PRP (ZPRD/ZATP, MM03, MD04, ME1M, ME2M, ME23N, MB52, ME03 & SE16) & MDGM Expert in using the functionalities Extract Data report - ERP (SAP) User Knowledge Assists in Process Improvement projects - NPDI Supports team members with Managing the records in addition to initiation - Trackwise/Mango Create new queries with existing dataset - BI Report Extraction/Query Designer/Aera/Palantir Supports team members and assist on using batchloader - Corpbase/Technical Documents/Image Loading Behavioral Competencies: Good oral and written communication skills Good organizational skills Proficient in Problem solving, Planning & execution Good understanding of management of interfaces and process understanding is required Good proficiency in Customer orientation, Business acumen and Leading change Some combination of the above may be acceptable

As the Head of Data Programming and Global Development Operations (GDO) Site Head India (Associate Director), you will have an exciting dual role that combines the best of both worlds In your role as Head of Data Programming, you will be part of the Data Monitoring, Management, and Innovation (DMMI) department You will have the opportunity to lead a team of clinical data programmers who work with advanced technical solutions such as SAS, R and other relevant applications You will manage/plan workload, set the team s strategy and priorities and mentor staff effectively In this role, you will contribute to global assets across a variety of therapeutic areas, shaping strategic decisions in clinical data programming and enabling the organization in activities like (medical) data review, safety surveillance and central data monitoring You will also be leading the Data Review Visualization and Reporting Governance In your role as the GDO Site Head India, you will be representing GDO leadership in the R&D organization in India That means that, although other functions will not report into you, you will be enabling the other GDO functions for all matter related to their team s roles in India That encompasses but is not limited to: 1) setting operational priorities and planning operational direction for the GDO India team in alignment with GDO functional leadership and planned key milestones and priorities; 2) be accountable for maintaining key performance indicators and metrics in collaboration with GDO key functions and team members; 3) provide leadership, direction and operational oversight for staff to ensure timely delivery and quality of assigned activities; 4) support GDO functional managers in resource management, planning and forecasting, and contribute to achieving functional objectives and company s strategic objectives; 5) representing GDO India at national and/or international forums as appropriate And finally, you will be an active member of the DMMI extended leadership team as well as the R&D India leadership team Who are youBSc or MSc (in a numerate discipline preferably in Mathematics, Statistics or Computer Science) or, alternatively a BSc or MSc, in a Lifesciences, Medical or PharmD supported by on-the-job training/certification in data programming or equivalentProven track record of success in statistical/data programming role, data management or equivlant roles at the global level in clinical development at a pharmaceutical/biotech company, or at a CRO, equivalent to a minimum of 10 years directly relevant experience Experience in an international environment with deliverables that were global, is a must Proven success as a people manager for 5+ years, including managing a team of statistical or data programmers Advanced skills in SAS and/or R Experience Python or other programming languages are a plus Full familiarity of CDISC SDTM standards are a mustStrong understanding of systems, processes and interfaces related to clinical development programsDemonstrated ability to manage assets effectively, ensuring timely delivery and quality outcomesAbility to provide solutions for complex programming challenges and evaluate alternatives to identify optimal solutions Having participated and succesfully led task forces or initiatives within and outside of the function, ideally at the global level

As part of our **hub-hub-spoke model**, this role will ensure seamless collaboration across stakeholders, foster a high-performing engineering & operations culture, and deliver technical excellence The ideal candidate will have deep engineering expertise, strong leadership skills, and the ability to manage a team of engineers (software, reliability and operations) while acting as a technical leader, consensus-builder & facilitator ---#### **Key Responsibilities****1 Leadership & Team Management**- Manage and mentor a team of engineers, including those focused on platform operations and reliability - Mentor engineers in their career development, identify talent, and foster an environment conducive to growth - Build a high-performing engineering culture by promoting automation, observability, collaboration, and accountability **2 Technical Leadership**- Provide deep technical expertise and leadership in managing the D&A Platform - Act as a trusted technical advisor to the Product Owners facilitating technical conversations and decision-making - Collaborate with architects and engineers across teams to ensure alignment on technical designs and solutions - Oversee the operational reliability, scalability, and security of the platforms **3 Stakeholder Collaboration**- Work closely with Product Owners to align engineering efforts with stakeholder value and business goals - Build communities of practitioners in Sector Data Offices and Business teams to drive shared best practices and engineering excellence - Facilitate collaboration between the MDAO Agile team and stakeholders across hubs and spokes **4 Platform Governance and Excellence**- Drive best practices in governance, monitoring, and security for the platforms - Ensure that platform reliability and operational excellence meet enterprise-grade standards - Stay abreast of advancements in platform engineering, cloud technologies, and software / data engineering, integrating relevant innovations into the team s work

Leadership & Team Management**- Manage and mentor a team of engineers, including those focused on platform operations and reliability - Mentor engineers in their career development, identify talent, and foster an environment conducive to growth - Build a high-performing engineering culture by promoting automation, observability, collaboration, and accountability Technical Leadership**- Provide deep technical expertise and leadership in managing the D&A Platform - Act as a trusted technical advisor to the Product Owners facilitating technical conversations and decision-making - Collaborate with architects and engineers across teams to ensure alignment on technical designs and solutions - Oversee the operational reliability, scalability, and security of the platforms Stakeholder Collaboration**- Work closely with Product Owners to align engineering efforts with stakeholder value and business goals - Build communities of practitioners in Sector Data Offices and Business teams to drive shared best practices and engineering excellence - Facilitate collaboration between the MDAO Agile team and stakeholders across hubs and spokes Platform Governance and Excellence**- Drive best practices in governance, monitoring, and security for the platforms - Ensure that platform reliability and operational excellence meet enterprise-grade standards - Stay abreast of advancements in platform engineering, cloud technologies, and software / data engineering, integrating relevant innovations into the team s work

Join us to contribute to the enterprise s priority of driving innovation through data & digital In R&D, the promise of bringing more medicines to more patients faster is closely linked with the ability to maximize the use of our data This will result in improved decision-making using data analytics & AI Well-structured, findable and easily accessible data is a core foundation, and we have therefore embarked on a mission to accelerate the provisioning of high-quality data As a Senior Data Engineer, your primary responsibility will be to implement high-quality, durable and efficient data flows You will collaborate closely with our product owners to optimize how we gather, structure and utilize data The data repositories, data flows and data-centric solutions you develop will support a wide range of reporting, analytics, decision support and (Generative) AI solutions You will leverage a Data & AI ecosystem built on modern AWS and Snowflake technologies and join a team of highly skilled experts Collaboration will be key, as you will work closely with the Data, Digital & IT team based at headquarters and developer teams located in Europe, US and India You will be the single point of accountability for the technical implementation of the data flows, repositories and data-centric solutions in your area, translating requirements into efficient implementations Who You Are:Bachelor s or master s degree in computer science, mathematics, or related fields At least 8 years of experience as a data warehouse expert, data engineer or data integration specialist Proven experience in implementing complex data models and data flows Familiarity with data & analytics solutions such as AWS (especially Glue, Lambda, DMS) and Snowflake Experience working with Azure Dev Ops and warehouse automation tools (egdbt, Coalesce) is a plus Strong proficiency in SQL, with additional knowledge of Python (ie pandas and PySpark) being advantageous A strong inclination to think about data flows end-to-end, from ingestion to data modeling and solution delivery Experience with Healthcare R&D is a plus Excellent English communication skills, with the ability to effectively engage both with R&D scientists and software engineers Experience working in virtual and agile teams

Purpose of the job:The Head of HRBP LS India is responsible for leading and implementing strategic people initiatives that drive business results of life Science India.This role involves partnering with senior business leaders of India (MD & ICC) to develop and execute HR strategies aligned with business objectives, fostering a high-performance culture, and ensuring legal compliance on all HR matters.To liaison with Global/Regional LS HRBP and HR solution partners to download and implement the global organization and talent initiatives in India. Strategic HR Leadership:Partner with senior business leaders to analyze business requirements and develop people strategies that drive business results.Provide insights to influence senior management s behavior, mindset, and people decisions for sustainable business growth.Translate business strategy into sector-specific HR initiatives supporting growth, and business transformation.Stakeholder Management:Assure strategic alignment and successful collaboration with critical internal stakeholder groups in the matrix organization and externally.Act as the main customer contact to business leaders and managers regarding HR solutions to make their business successful.Team Leadership:Lead, empower, and inspire a team of country HRBPs to achieve ambitious business targets and ensure successful implementation and execution of people components within area of responsibility.Develop an effective and efficient setup considering business complexity and strategic journey.Drive adoption of the new HR organizational model, including shared/self-services and management accountability.Talent Management:Ensure workforce planning, talent acquisition, succession planning, and leadership development initiatives are aligned with the company s talent strategy.Foster robust pipeline talent development and succession planning for business-critical positions, with a focus on diversity and inclusion.Collaborate with Learning & Development to create training programs that foster continuous learning.Operational HR Support:Implement employee-centric people topics, focusing on onboarding, engagement, compensation & benefits, people development, performance management, labor & employee relations.Deliver HR support for all employee lifecycle solutions in collaboration with Market Solutions Partners, with support of GES.Ensure legal compliance on people and HR matters.Change Management:Support change management adoption and cultural transformation strategies to enable business success.Provide guidance to business leaders to help them effectively manage change and ensure business continuity.Lead and drive the execution of organization transformation projects. Data-Driven Decision Making:Use multiple data sources and people analytics to create critical people insights, monitor business performance, opportunities, and risks.Leverage state-of-the-art HR practices and processes, applying technology, analytics, and forward-thinking methodologies to enhance employee experience. Who you are:Business and/or HR-related professional qualificationExtensive experience (15+ years) in HR with proven progressive HRBP with business and HR Strategic responsibilities, experience in Healthcare & Life Science is a plus.Leadership experience in a matrix organization, with strong influencing skills and cultural adaptiveness.Experience in supporting business growth, implementing global People Strategies, and advising senior leaders on strategic People decisions.Business acumen paired with a hands-on mentality and the ability to match business needs with HR deliverables.Excellent communicator with experience in consulting, engaging, and influencing senior business leaders.Analytical and data-driven, with the ability to integrate complex data into insights to create future-focused, high-impact people business strategies.

6- 8 Years of experience in Regulatory Submission Management3 Years of experience in Veeva Vault Manage and execute planning, compilation and dispatch of submissions to Health Authorities during the application lifecycle Create and update submission packages and Submission Content Plans for submissions to Health Authorities Create and update records in Regulatory Information Management system and ensure submissions are documented properly including tracking of HA questions and documentation of approval and registration details in Veeva Vault RIM Liaise and follow-up with R&D functions to provide required submission-relevant documents on time and in submission ready format Perform quality checks, validate eCTD output, and submit eCTDs through supported HA gateway Collaborate with submission management and publishing vendors, resolve or coordinate any queries, and perform spot checks on output Functional oversight of vendors for submission management and publishing Crisis intervention in case of vendor issues to avoid impact on quality or project timelines Key contact for eCTD and Publishing expertise Act as power-user for submission applications (Veeva Vault RIM) Author cover letter and application forms in close cooperation with the License Manager or Regulatory Lead Monitor compliance with submission standards and submission process (internal & external) Manage and improve quality of submission standards and templates for submission-relevant documents ensuring compliance with HA requirements

Management and Planning: Ability to execute assigned tasks independently Adherence to agreed timelines and proactive communication of any potential risk to the same, follow up with cross functional contributors on their deliverables in a proactive and timely manner Strong project management and documentation skills, proactive communication approach Maintain appropriate risk assessment and mitigation in cooperation with line manager /team lead Ability to work within a matrix organisation, build relationships with internal or external stakeholder Provide high quality deliverables as per company standards, right first time Profound knowledge of the companys systems and databases (APT, Trackers, RIMS/Veeva, EDMS) Familiar with the organization and able to identify relevant contributors and stakeholders within the organization as per project Providing Regulatory expertise into the planning and execution of projects and tasks Acts as a role model and helps the more junior staff to improve their business communication skills Encourages team/peers to take an active role in networking activities within own area of specialization/ project environment Focuses on facts and quality of work rather than origin of ideas (does not follow cultural stereotypes) Recognizes other s point of view and makes sure that everyone is listened to and understood Demonstrates high proficiency and delivers high quality influential presentations within the own area of specialization/ project environment Facilitates effective teamwork in own area/project by unearthing and managing conflicts effectively Pursues active networking within and often beyond disciplines/ areas, projects Reaches out to international colleagues and plays an active role in the international expert community Systems and Applications: Upon completion of a dedicated training, user can perform routine/ standard activities within the RA systems with no supervision required The output of the user will usually undergo standard QC/spot check procedure Regulatory Expertise: Solid experience in Regulatory Affairs regulatory dossiers and regulatory procedures on a global scale, including submission/registrations types and related requirements Understanding of Regulatory Agencies structure, processes and key personal as applicable In Ability to review and interpret country specific and international regulatory guidelines, policies and regulations to generate submission ready deliverables as per request Pharma business acumen: Have a good understanding on how business operates and makes smart decisions trying to see the big picture without losing view of the details Ability to develop and prepare successful regulatory CMC strategies and CMC dossiers Practical experience in one of the following areas for synthetic molecules and/or biotech molecules: manufacturing process development, transfers, validation or analytical development and quality management In-depth knowledge of global pharmaceutical legislation specifically linked to regulatory CMC aspects in the ICH countries Position may require both domestic and international travel Qualification: Degree in Pharmacy or Life Science, Medical, PharmD or related discipline (minimum MPharm or MSc or equivalent degree), higher degree preferable (eg PhD in a scientific discipline) Experience Required: More than 7 years of overall work experience in Pharma environment, Competent authority or Academia/R&D experience related to the role Minimum 3 years of Global CMC regulatory experience User has advanced skills with all standard MS office and business applications (word, excel, power point, MS project, outlook, skype, SharePoint) User has contributor level of experience with RIMS / Veeva and EDMS RA application Key Skills: Experience in Regulatory Affairs CMC activities of Biologics / Biosimilars / Injectables is an added advantage to this position Experience in preparation and management of regulatory CMC documentation, including normally a full international submission (new product application) or complex variations Experience with life-cycle management activities in at least two regions (eg Europe, USA, International would be an asset) Experience with ROW countries and awareness of regulatory affairs CMC contribution to Pharma business Depth knowledge in Regulatory Affairs and experience of working in a global regulatory environment including exposure to registration procedures (CP, MRP, DCP, National etc) and LCM strategies Communication and Collaboration: Excellent written and spoken English language

The MR will ensure that all quality-related activities align with the organizations goals, objectives, and regulatory requirements This role requires close collaboration with all Centre of Excellence (COEs) to promote a culture of quality and drive process excellence Key Responsibilities :QMS Implementation Maintenance:Develop, implement, and maintain the Quality Management System (QMS) in accordance with ISO 9001:2015 standards Ensure that the QMS processes are established, implemented, and maintained effectively across the organization Management Review:Organize and lead Management Review meetings, ensuring that top management is fully informed of the QMS performance, including any needed improvements Prepare and present data on the performance of the QMS, including key performance indicators (KPIs), audit findings, and customer feedback Internal Audits:Plan, schedule, and conduct internal audits to ensure the QMS meets ISO 9001:2015 requirements Identify non-conformities and opportunities for improvement, and work with relevant departments to develop and implement corrective actions Document Control:Manage the control of documents and records within the ManGo System, ensuring that they are accurate, current, and readily accessible to relevant personnel Ensure that all quality-related documentation is in compliance with ISO 9001:2015 standards Continuous Improvement:Promote a culture of continuous improvement within the organization by identifying areas for process enhancement and efficiency Lead or participate in quality improvement projects, including root cause analysis and problem-solving activities Training Development:Provide training and support to staff on ISO 9001:2015 requirements and the organizations QMS Ensure that all employees are aware of their roles and responsibilities within the QMS Customer Satisfaction:Monitor and analyze customer feedback and complaints to ensure customer satisfaction Implement corrective actions to address customer concerns and improve overall quality External Audits Certification:Serve as the primary point of contact for external auditors and certification bodies Prepare for and coordinate external audits, ensuring that the organization maintains its ISO 9001:2015 certification Qualifications: Education:Bachelor s / Masters degree in any discipline Experience:Minimum of 5-8 years of experience as a Management Representative, with a focus on ISO 9001:2015 Proven experience in managing a QMS and leading internal audits Certifications:ISO 9001:2015 Lead Auditor Six Sigma or Lean certifications are a plus Skills:Strong knowledge of ISO 9001:2015 standards and requirements Excellent communication, leadership, and organizational skills Proficiency in QMS software and tools Ability to work collaboratively with cross-functional teams Personal Attributes:Detail-oriented with strong analytical skills Proactive and self-motivated with the ability to work independently Strong problem-solving skills and the ability to think critically Commitment to upholding the highest standards of quality

Join our dynamic team as a Compliance Expert in Functional Solution Accounting Finance! In this role, you ll be the go-to person for ensuring that we stick to our Internal Controls Financial Reporting (ICFR) framework You ll collaborate with the Global ICFR Team and various stakeholders to ensure our risk and control measures are top-notch You ll drive risk assessments, coordinate annual sign-offs, and oversee control testing by auditors Your insights will help us enhance our processes and identify gaps, making a real impact on our organization Plus, you ll maintain our SAP Governance, Risk, and Compliance (GRC) System and lead initiatives to prevent Segregation of Duties conflicts This role is based in Poland and may require some travel We re excited to offer you growth opportunities as you help shape our compliance landscape!Who You Are: Bachelor s degree in Business Economics, Finance, Compliance Risk Management, or a related field At least 5 years of relevant experience, including working with external auditors Solid understanding of Accounting and Finance processes Excellent problem-solving skills and a willingness to challenge the status quo Proficient in English, both written and spoken Familiarity with industry standards/frameworks like ISO, SOX, and COSO, along with authorization/SOD management, is advantageous Effective communicator who thrives in a global team and works independently Your main benefits:Health and well-being: Get access to private medical care, life insurance, and sports card, receive prepaid lunch card Work-Life balance: Enjoy additional paid days off, flexible working hours, and a hybrid working model Learning and Development: Take advantage of co-financing for language courses, trainings, and certifications as well as other development opportunitiesEmployee support and engagement: Benefit from Employee Assistance Program and join employee engagement groups for support and connection Information on how we process your personal data for recruitment purposes, you can find on the registration form in our Recruitment Porta