Dir Gsd jobs at Teva in India, Bengaluru

• Ensures that the Product Quality Reviews / Annual Product Reviews for Teva products are completed in a timely and compliant manner as per Teva’s CORP Quality Management systems. PQR/APR compilation and approval must be well associated with the Teva Manufacturing Sites, Global Quality Units and Commercial affiliates to meet the targets and ensure compliance.
• Ensures timely and accurate data migration in collaboration with sites and Global IT / IT Quality
• Ensures timely review of CMC documentation in collaboration with Global R&D sites
• Defines team operating standards and ensures essential CORP and local procedures are followed based on knowledge of own discipline.
• Manages and supervises a team of up to 100 professional employees consisting of sr. managers, managers, authors reviewers and approvers.
• Is accountable for the performance and results of a teams within the function Global Quality GBS.
• Creates and adapts departmental plans and priorities to address resource and operational challenges.
• Ensures that decisions are guided by CORP policies, procedures and Global Quality´s business plan.
• Receives guidance from Senior Director Quality Strategy and Shared Services, SVP Global Quality, other Managers in Quality Strategy and Shared Services, Global R&D, Global IT, EMSO Quality affiliates, Commercial Quality EU & IM, TGO sites.

A.Review and approval of PQR’s

The owner of the function

• Review of Annual Product Reviews (APRs) / Product Quality Reviews (PQRs) for products supplied by external vendors and manufactured at external manufactures
• Conduct review of (APRs) / Product Quality Reviews (PQRs) prepared by team members to ensure high quality of the reports prepared by the team.
• Recommend actions and communicate to stakeholder for identified actions as part of the review process to improve quality of products(CAPA)
• Approve Annual Product Reviews (APRs) / Product Quality Reviews (PQRs) which do not require approval step by any other TEVA /non-TEVA stakeholder like QPs, RPs or FvPs.
• Support and guide in escalation of PQR issues and initiate and conduct meetings / telecons if required on priority.

B.Data Migration

• Ensure Data Migration is performed in accordance with TEVA requirements in the pre-given timeline and accuracy
• Support and guide in escalation of DM issues and initiate and conduct meetings / telecons if required on priority.
• Escalate the issues of the DM team to higher management for non-responsive TEVA’s internal stake holders, missing resources, missing commitments etc.

C.R&D CMC Documentation
• Ensure review of CMC documents received from R&Ds is performed in accordance with TEVA requirements in the pre-given timeline and accuracy
• Support and guide in escalation of issues and initiate and conduct meetings / telecons if required on priority.
• Escalate the issues to higher management for non-responsive TEVA’s internal stake holders, missing resources, missing commitments etc.

D.Quality Management Systems

The owner of the function

• Ensures that the local quality management system is maintained at GBS Quality function.
• Ensures that the local Quality Management System is compliant with respective regulatory guidelines and TEVA´s CORP QMS (Gap Assessments)
• Approves process of change controls and deviations
• Approves local SOP’s and its related documents.

E.Performance Management

• Monitors and compiles the KPI scores of the various business units and supports the team to improve their efficiency.
• Participates in the customers council meetings and supports the effectiveness of the councils.
• Leads or participates in the Monthly Quality Council and enhances the effectiveness and efficiency of it by suitable reports/metrices and continuous improvement.

The incumbent

• Approves Training Materials for GMP training and on the job training.
• Imparts training on procedures as needed.
• Reviews the training status of the team and regularly verifies that training was performed in time and successfully.
• Certifies trainers and self-inspectors to enable them to impart training and conduct self-inspection.

G.Miscellaneous Support

The owner of the function is responsible for

• Hiring of new Headcount and monitoring the Head count status
• Maintaining Employee Central and other relevant Master Data
• Liase with Finance related to the HC cost
• Responsible for approval of PR’s related to purchase of PQR’s.
• Review the invoicing cost involved with respect to the status.
• Approval of POs in SAP- for hiring and other requests like purchase orders for costs involved in updation of software
• Review monthly report to be presented to higher management

• More than 15 years of experience in QA / QC function in the pharmaceutical industry
• More than 5 years of experience in a managerial role
• Well-founded knowledge on worldwide cGxP regulations
• Excellent English language skills, other language skills could be helpful
• Very Good communication skills and ability to work in a matrix structure
• Very good knowledge of Computerised Systems in TEVA´s IT landscape (Track-Wise, SAP, LIMS, Global Insights, Glorya etc.)
• Good understanding of manufacturing, QC and Contract manufacturing processes
• Engagement to drive improvements and ability to manage complexity
• Mobility

VP Global Quality SMSO

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

The Associate Director, Complex Gx, Regulatory Affairs serves as a strategic regulatory leader, responsible for independently guiding and executing all regulatory activities—both pre- and post-approval—for U.S. FDA-regulated semi-solid, transdermal, and nasal spray complex generic products. This role ensures regulatory compliance, drives operational excellence, and leads a team of regulatory professionals to deliver high-quality submissions and lifecycle management initiatives. The Associate Director acts as a key liaison with the FDA, internal cross-functional teams, and external partners. This role will also facilitate strategic alignment with FDA through early and proactive engagement during product development, enabling streamlined development pathways, mitigating regulatory risk, and accelerating time-to-market—ultimately increasing the likelihood of first-cycle approvals.

• Provide strategic leadership and oversight for regulatory submissions (original applications, supplements, and responses) for complex generic products, specifically semi-solids, transdermals, and nasal sprays.
• Drive early FDA engagement to align on development strategy, reduce regulatory risk, and support first-cycle approvals.
• Lead regulatory assessments and decision-making for significant changes, including site transfers, formulation modifications, and alternate API sourcing.
• Ensure submission documents are accurate, complete, and compliant with FDA regulations, promoting a Right-First-Time approach to maximize first-cycle approvals.
• Represent Regulatory Affairs in global and regional forums, contributing to strategic planning and regulatory alignment.
• Interpret and apply FDA regulations and guidance to both new and marketed products, ensuring compliance while fostering innovation.
• Develop and implement regulatory strategies aligned with global business objectives.
• Collaborate with cross-functional teams (e.g., R&D, QA, Manufacturing) to resolve regulatory challenges and streamline processes.
• Champion continuous improvement initiatives and introduce innovative solutions to enhance regulatory efficiency.
• Oversee regulatory documentation systems, ensuring data integrity and consistency across submissions.
• Lead departmental planning, resource management, and policy development.
• Mentor and develop regulatory staff, supporting leadership growth and succession planning.
• Foster a culture of transparency and open communication across all levels of the organization.
• Monitor and optimize key performance indicators (KPIs), including submission timelines, quality metrics, and team development goals.
• Communicate organizational updates and priorities clearly and effectively to the team.
• Manage departmental budgets related to regulatory submissions and administrative operations.
• Serve as a delegate for senior leadership in executive forums, representing the regulatory function.
• Identify and cultivate new opportunities that align with organizational goals and future capabilities.
• Support internal and external audits and regulatory inspections as required.
• Build and maintain strong working relationships with FDA project managers.

• Bachelor’s or Master’s degree (preferred) in Pharmacy, Life Sciences, or a related field (e.g., M.Sc., Ph.D.).
• Minimum 12+ years of pharmaceutical industry experience, including at least 8+ years in U.S. Regulatory Affairs with a focus on complex generic drug products including semi-solid, transdermal, and nasal spray generic drug products.
• At least 6 years of proven leadership experience managing regulatory teams and complex product portfolios.
• In-depth knowledge of FDA regulations (21 CFR 314.70), ICH guidelines, and eCTD submission standards.
• Proficiency with regulatory systems (e.g., Veeva, TrackWise) and electronic document management platforms (e.g., Wisdom, Glorya, Livelink, Knowledgetree).
• Solid understanding of pharmaceutical drug development processes.
• Demonstrated success in FDA interactions, with strong negotiation and influencing skills.
• Excellent verbal and written communication skills.
• Experience working in matrixed, multinational environments and with third-party partners.
• Lean Six Sigma certification or equivalent process improvement training is a plus.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

• The Director reports directly to the Head of Global Statistics, Data Science, and Medical Writing (GSD) and serves as a member of the GSD Leadership Team. This role oversees GSD India-based employees across Data Management, Statistics, Programming, and Medical Writing, managing key administrative responsibilities such as timesheet approvals, time-off requests, performance evaluations, and career development. The Director collaborates with HR to resolve employee concerns and partners with global functional heads for resource planning and assignments. While functional project leads provide day-to-day guidance, the Director ensures team members receive clear direction and coaching to support successful execution. A core focus of the role is fostering a unified GSD India community that is well-integrated with the global organization.
• In addition to operational leadership, the Director brings deep expertise in data functions, drug development, and clinical research, including regulatory interactions both within and outside the U.S. They provide strategic guidance across compounds or therapeutic areas, offering critical thinking that influences clinical development programs, study design, and analysis. The Director is well-versed in drug development principles, innovative trial approaches, and relevant tools and software. Strong communication skills and the ability to influence cross-functional teams are essential, as this role has significant visibility and impact across drug development programs and senior leadership

• Provides strategic and scientific leadership to the clinical development, registration strategy, submission, health authority interactions, and medical affairs/market access plans for complex programs across multiple diseases
• Organizational leader that is a key contributor in defining and driving the line function strategy
• Leads and optimizes the contribution from the team(s) by collaborating and consulting with key partners, exhibiting a comprehensive understanding of drug development and associated operational requirements whilst demonstrating modern, enterprise, global leadership skills
• Strategic and/or managerial responsibilities for GSD India team across multiple programs/indications of Teva. Independently lead (large) programs and accountable for the GSD India deliveries and influence for the programs
• A modern drug development global leader – operate as a full partner to clinical and scientific leadership. Ensures effective partnership with other functions including clinical, regulatory and other strategic functions to drive quantitative decision sciences / making in drug development and enable successful impact on CDPs (Clinical Development Plan), programs and trials
• Interacts and manages KOLs/CROs and represents the company in external scientific and industry forums
• Is seen as a strategic Business partner involved in high-level decisions having an impact on the organization globally
• Drives GSD India Team it through the use of novel/innovative clinical trial designs and statistical or other data related methodology
• Becomes proficient in the knowledge of the therapeutic area and competitive landscape of the specified therapeutic area
• Prepares, or oversees the preparation of, statistical sections of clinical protocols in collaboration with GSD global team and Clinical Research personnel as needed
• Supports due diligence activities
• Forecasts and maintains budgets
• Primarily works at the TA / Functional Level
• Oversee direct reports; Oversee contingent workers and/or vendors; Provide training to others; Strategically analyze needs to manage resources and accountable for resource allocation
• Accountable for delivering assignments with quality and within timelines

• Ph.D./MS in Statistics/Biostatistics (or data related field or Medical Writing related field )
• MS with a minimum of 8 years of related experience; PhD with a minimum of 6 years of related experience

• Accountable to support all activities related to Regulatory Life Cycle Management activities in Worldwide Markets (EU, US, Other Markets: CMC Variations, Renewals, PSUR, RMP, safety variations etc)
• Hiring, Training and Retention of Staff in the team
• Work closely with Worldwide markets, assesses dossier suitability and creates a submission tracker for all assigned products to ensure appropriate planning and prioritization.
• Work closely with global regulatory teams in the EU/US/Other International Markets to support Life Cycle Management activities within Regulatory Affairs
• Coordinate responses to Health Authorities, with appropriate personnel and departments to resolve outstanding regulatory issues.
• Ensure that cross-functional activities to support submissions and works collaboratively with Market RA to ensure all requirements are met and dossiers are submitted as per the submission plan.
• Establish vision for the team, team building activities, planning and prioritization of daily work and regular business updates to management.

• B. Pharmacy/M. Pharmacy/MSc/Ph.Din Biology/Chemistry
• Experience: 12 to 15 years in RA
• Expertise in global regulatory strategies and life cycle management activities for Worldwide Markets
• Ability to work proactively and independently in a global environment
• Ability to plan, organize and execute projects as required within Global Regulatory Affairs
• Strong Leadership Experience with ability to build a collaborative environment within the team with positive work culture and develop junior staff members.

• Good leadership, project management and communication skills
• Excellent analytical, problem-solving, and self-learning skills.
• Ability to work independently and effectively in a cross-functional team environment;manage multiple projects simultaneously.
• Detail-oriented with a high level of accuracy in work deliverables.
• Strong organizational and time management skills.
• Excellent spoken and written English is essential.

• The ICSR Global Operations Leader is accountable for the end-to-end execution of global ICSR operational activities, including oversight and proactive management of vendor-delivered services. Reporting to the Head of Systems Data Innovation (SDI) and IL Site Lead, this role is a key member of the global SDI leadership team.
• The role leads and ensures a high-performing global team, ensuring full compliance with internal procedures and regulatory requirements while driving continuous improvement across the ICSR lifecycle - from case intake to timely, high-quality data entry and submission. It is responsible for the day-to-day execution, monitoring, and optimization of ICSR processes, with a strong focus on operational efficiency, quality, and adherence to industry standards.
• As a senior leader, the ICSR Global Operations Lead plays a pivotal role in shaping and implementing SDI strategies in close partnership with SDI leadership, cross-functional collaborators, and both internal and external stakeholders. The role provides strategic direction on operational excellence, compliance, resource planning, and global team development.
• This leader is expected to bring an adaptive, innovative mindset - serving as a change agent who empowers the team, translates strategic vision into operational reality, and champions the value of safety case management across Teva and within the broader pharmacovigilance ecosystem. With direct responsibility for both people leaders and individual contributors, the role also includes mentoring, coaching, and developing talent across regions, with a special focus on supporting the growth and engagement of the PV India team in alignment with Teva’s global PV strategy.

1. Global ICSR Ownership & Compliance Leadership

• Serve as the Senior SME and global owner for end-to-end ICSR operations (post-marketing), accountable to meet or exceed the KPIs for ICSR quality, compliance, and operational delivery worldwide.
• Lead daily operational execution, ensuring timely case processing, proper prioritization, and resolution of workflow issues in collaboration with the relevant stakeholders.
• Contribute to the development, implementation, and maintenance of SOPs and WIs, ensuring adherence to international regulatory requirements and audit/inspection readiness.
• Oversee CAPAs, deviations, and regulatory updates for own area of responsibility, with full accountability for timely closure and continuous improvement.
• Process ICSRs in the global safety database from time to time (2-4 cases / week) - maintaining a close connection to real-time operations and reinforcing practical leadership.

2.Strategic Direction, Innovation & Process Excellence

• Define and execute the strategic roadmap for ICSR operations, aligned with Teva’s global PV vision, industry trends, and evolving regulatory expectations.
• Lead the development of robust real-time monitoring and forecasting models to support seamless execution, enhance case processing KPIs, improve operational visibility, and increase predictability and agility—shifting the organization from a reactive to a proactive, forward-looking approach.
• Champion innovation, leveraging advanced technologies such as automation, bots, and AI to drive efficiency, scalability, and simplification.
• Evaluate and enhance operating models to optimize resource use, compliance, and data quality.

3.Stakeholder Partnership & Cross-functional Engagement

• Act as the global point of contact for all stakeholder interfaces related to case intake, including Clinical Operations, Medical Affairs, and Quality.
• Establish and maintain strong, visible relationships with key partners to ensure a seamless flow of safety information and shared accountability.
• Lead and influence global working groups, forums, and cross-functional initiatives to drive alignment and best-practice adoption.
• Provide strategic insights and data to PV core leadership team to support decision-making and long-term planning.

4.Vendor & Partner Management

• Own the global vendor relationship for ICSR processing activities, including selection, performance oversight, and contractual adherence.
• Define and track vendor KPIs, conduct regular reviews, and drive accountability for quality, compliance, and operational excellence.
• Foster transparent, proactive communication with vendors and external partners to ensure aligned expectations and continuous performance improvement.

5.
Team Leadership, Development & Engagement

• Lead, mentor, and develop a high-performing global ICSR operations team with clear goals, IDPs, and accountability structures.
• Promote a culture of ownership, innovation, and continuous improvement across all team members.
• Address people-related matters proactively and partner with HR and site leadership to ensure engagement, clarity of roles, and talent growth.
• Align team capacity and structure with business needs to ensure readiness and resilience.

• Minimum Master's degree in Life Sciences or another related field.
• Minimum of 10 years of experience in pharmacovigilance with strong knowledge of ICSR lifecycle and regulatory requirements.
• Minimum of 5 years of managing global teams and complex projects.
• Experience in inspections/audits and readiness activities is a strong advantage.
• Fluent in English.