Mgr Ra Eu Generics Labeling jobs at Teva in India, Bengaluru

• Management of the submission and approval process for Teva products in APAC Region (Australia, New Zealand, Singapore, Malaysia etc) to support business opportunities for the company.
• Management of regulatory compliance including product maintenance, data sheets, labelling, regulatory compliance files and regulatory databases.
• Support new product launch activities including coordinating regulatory requirements, artwork approval and providing technical input into any product related materials required for market introduction.

Regulatory Submissions

• Manage all submissions and maintenance activities related to Branded/Specialty and Generic products in APAC region.
• Ensure full compliance of marketed products according to local regulations by proactively managing and monitoring change control with sites/suppliers and global RA WP. Manage local regulatory planning process for post-approval changes, including variations, site transfers and compliance related activities to support supply continuity.
• Manage activities within Regulatory Systems and keep up to data as per compliance requirements (GRIDS, GI Insights, Teva Art, Veeva etc)

Regulatory Intelligence/Expertise/Guidance/Education

• Provide regulatory guidance to ensure that Teva can meet the responsibilities of an importer, distributor and sponsor, to ensure supply of safe and effective medicines, including supply of unapproved medicines, as required by Health Authorities
• Provide regulatory intelligence and maintain thorough and up-to-date understanding of the regulatory environment in APAC region by providing impact analysis feedback to commercial teams..
• Capture monthly activities via reports and capture RA activities on an ongoing basis in the regulatory tracking system.
• Ensure regulatory records and files are maintained electronically for ready record retrieval and life cycle management, in accordance with global and local requirements.
• Monitor, collect and interpret regulatory guidelines and trends that will impact marketed and planned products, share this information with appropriate personnel and assist in the development of strategies and plans of action to address them.
• Work closely with market RA in APAC region to complete all assigned activities

• B. Pharm / M. Pharm (preferred) with 10+ years of experience
• Good knowledge and understanding of pharmaceutical & scientific processes as well as registration and assessment of human medicinal products and medical devices.
• Experience in Generics, Biosimilars or Innovative Medicines in Regulatory Affairs (APAC preferred) and knowledge of regulatory and healthcare system in APAC (Australia, New Zealand, Singapore, Malaysia etc)

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.

As a Project Manager (7-8 years experience), you will be responsible for managing large-scale, multi-million-dollar transformation projects, primarily focusing on Cloud Migration and Data Center Consolidation. You will collaborate closely with cross-functional teams, senior leadership, clients, and vendors to ensure successful project delivery while driving alignment on project goals, timelines, and budgets. Your leadership and strategic insights will help drive the transformation efforts to meet business objectives and exceed client expectations.

1. End-to-End Project Management:
o Develop and manage comprehensive project plans, timelines, and budgets to deliver the project on time and within budget.

2. Stakeholder & Vendor Management:
o Serve as the primary point of contact for internal stakeholders, clients, and vendors, ensuring seamless communication and transparency across all parties.
o Manage relationships with key stakeholders, providing regular project updates and ensuring the alignment of expectations.
o Coordinate with third-party vendors and contractors for resource allocation, service delivery, and technical support.

3. Risk & Issue Management:
o Proactively identify and mitigate risks associated with Cloud Migration and Data Center Consolidation projects.
o Establish clear processes for issue tracking, escalation, and resolution to ensure minimal disruption to project timelines.
o Implement risk management strategies to protect project timelines, budgets, and quality standards.

5. Financial & Budget Management:
o Own project financials, ensuring accurate forecasting, cost control, and delivery within the approved budget.
o Track project expenditures and identify potential cost-saving opportunities without compromising quality.

6. Process Improvement & Best Practices:
o Continuously evaluate and improve project management processes and methodologies.
o Ensure that projects are executed in line with industry best practices and internal standards, including Agile and Waterfall methodologies, depending on project needs.

7. Cloud & Data Center Transformation Expertise:
o Leverage deep expertise in Cloud Technologies (AWS, Azure, Google Cloud) and Data Center Infrastructure to drive successful project outcomes.
o Provide strategic guidance on cloud architecture, migration strategies, and data center optimization efforts.
o Stay current on emerging trends and technologies in the cloud and infrastructure space to provide valuable insights to the team and stakeholders.

• 7-8 years of experience in managing large-scale infrastructure projects, with a focus on Cloud Migration and Data Center Consolidation.
• Bachelor’s degree in Engineering, Computer Science, Business Administration, or a related field.

As a Project Manager (7–8 years of experience), you will work on high-impact AMS transformation programs. You will coordinate across a diverse set of applications and stakeholders, helping ensure service continuity, regulatory compliance, and continuous improvement while supporting cross-functional delivery teams, senior leadership, and vendor partners.

1. AMS Project Delivery & Governance
• Ensure smooth and compliant execution of AMS operations, meeting SLAs, KPIs, and GxP standards.
• Support managed services initiatives for enterprise applications like MES, Veeva, SFDC, CRM, ReadSoft, and PLM.
• Drive transformation across people, process, and technology under a service-oriented model.
2. Stakeholder & Vendor Management
• Collaborate with internal IT teams, business stakeholders, and global vendor partners to align on project objectives.
• Coordinate with multiple vendors for service delivery, pricing discussions, and performance tracking.
• Support contract management activities including SoWs, change requests, and procurement coordination.
3. Planning, Tracking & Risk Management
• Contribute to planning and tracking of budgets, schedules, and deliverables for multi-million-dollar AMS programs.
• Identify, assess, and mitigate risks and issues impacting project timelines and service outcomes.
• Maintain structured documentation and reports aligned with internal audit and regulatory requirements.
4. Communication & Reporting
• Prepare and deliver executive-level project updates, dashboards, and service review reports.
• Facilitate cross-functional communication across business, IT, and vendor ecosystems.
5. Process Discipline & Compliance
• Ensure full adherence to GxP and pharmaceutical regulatory standards.
• Promote documentation and audit-readiness culture across AMS lifecycle.

• 7–8 years in project management, with at least 5 years in AMS or transformation in large-scale environments.
• Familiarity with pharma regulations (GxP), AMS operating models, and regulated application landscapes.

• Ensure the pharmaceutical, medical, and regulatory accuracy of English product information (SmPC, Labeling, PIL) for European procedures (MRP, DCP, CP) of innovative, biosimilar and generic products.
• Provide internal pharmaceutical and medical expertise to address internal and authority-related inquiries and resolve labeling issues.
• Ensure regulatory compliance for all maintained innovative, biosimilar and generic EU procedures (MRP, DCP, CP) regarding labeling.

1. Labeling
• Responsible for creating and updating compliant English product information for EU procedures.
• Strategic planning and implementation of changes affecting multiple product information documents.
• Determination of an implementation plan and tracking the implementation of updates due to new requirements (e.g. new excipients warnings, QRD template update).
• Providing instructions and guidance to local RA (e.g. calculations due to new excipients warnings).
• Discussion of the content of product information for innovative products (pre- and post-approval) in project teams.
• Evaluate and approve change requests; coordinate submissions with EU regulatory units.
• Collaborate on patent-related issues with Global IP Group.
• Contribute to readability studies and ensure PIL readability and compliance with legal requirements.
• Adaption to reference medicinal product (generic, hybrid, biosimilar procedures).
• Preparation of Expert statements (justification) for type II variations.
• Providing scope of variation to regulatory affairs.
• Performing plausibility check and providing wording to be in line with QRD requirements and Standard Terms for module 3 updates.

CONTD...

1. Monitoring
• Monthly monitoring and communicating safety updates from EU authority websites.
• Track reference product updates and legal/guidance changes affecting product information.
2. Pharmacovigilance
• Assess need for updates based on Company Core Safety Information (CCSI).
• Implement PV triggered and non-PV triggered safety updates (e. g. PRAC/PSUSA/PSUFU, Referrals (Articles 31 + 107i), article 30 procedures, etc.) in line with SOPs; collaborate on safety-related actions with Pharmacovigilance and QA.
• Participation in Product Safety Group (PSG) Meetings.
• Implementation of internal signals (including determining PIL wording).
3. Scientific Work & Authority Communication
• Participate in project teams to fix the regulatory strategy and prepare expert statements.
• Respond to authority deficiency letters in collaboration with other departments.
4. Mockups
• Coordinate creation and approval of packaging mockups, Braille, and specimens.
• Address authority queries and ensure compliance with EU regulations.
5. Training
• Assist with training new team members

• Experience: 6 to 7 years in relevant fields (medicinal information and EU labeling in the pharmaceutical industry) ideally in Regulatory Affairs.
• Education: Completed at least 8-semester university degree in natural sciences (e.g., Pharmacy [preferred], Biology, Human Biology, Medicine, Food Chemistry), preferably with a PhD.
• Other: Advanced English (spoken and written), strong MS Office skills, knowledge of European pharmaceutical law and regulatory affairs.

• Ensure the pharmaceutical, medical, and regulatory accuracy of English product information (SmPC, Labeling, PIL) for European procedures (MRP, DCP, CP) of innovative, biosimilar and generic products.
• Provide internal pharmaceutical and medical expertise to address internal and authority-related inquiries and resolve labeling issues.
• Ensure regulatory compliance for all maintained innovative, biosimilar and generic EU procedures (MRP, DCP, CP) regarding labeling.

1. Labeling
• Responsible for creating and updating compliant English product information for EU procedures.
• Strategic planning and implementation of changes affecting multiple product information documents.
• Determination of an implementation plan and tracking the implementation of updates due to new requirements (e.g. new excipients warnings, QRD template update).
• Providing instructions and guidance to local RA (e.g. calculations due to new excipients warnings).
• Discussion of the content of product information for innovative products (pre- and post-approval) in project teams.
• Evaluate and approve change requests; coordinate submissions with EU regulatory units.
• Collaborate on patent-related issues with Global IP Group.
• Contribute to readability studies and ensure PIL readability and compliance with legal requirements.
• Adaption to reference medicinal product (generic, hybrid, biosimilar procedures).
• Preparation of Expert statements (justification) for type II variations.
• Providing scope of variation to regulatory affairs.
• Performing plausibility check and providing wording to be in line with QRD requirements and Standard Terms for module 3 updates.

CONTD...

1. Monitoring
• Monthly monitoring and communicating safety updates from EU authority websites.
• Track reference product updates and legal/guidance changes affecting product information.
2. Pharmacovigilance
• Assess need for updates based on Company Core Safety Information (CCSI).
• Implement PV triggered and non-PV triggered safety updates (e. g. PRAC/PSUSA/PSUFU, Referrals (Articles 31 + 107i), article 30 procedures, etc.) in line with SOPs; collaborate on safety-related actions with Pharmacovigilance and QA.
• Participation in Product Safety Group (PSG) Meetings.
• Implementation of internal signals (including determining PIL wording).
3. Scientific Work & Authority Communication
• Participate in project teams to fix the regulatory strategy and prepare expert statements.
• Respond to authority deficiency letters in collaboration with other departments.
4. Mockups
• Coordinate creation and approval of packaging mockups, Braille, and specimens.
• Address authority queries and ensure compliance with EU regulations.
5. Training
• Assist with training new team members

• Experience: 6 to 7 years in relevant fields (medicinal information and EU labeling in the pharmaceutical industry) ideally in Regulatory Affairs.
• Education: Completed at least 8-semester university degree in natural sciences (e.g., Pharmacy [preferred], Biology, Human Biology, Medicine, Food Chemistry), preferably with a PhD.
• Other: Advanced English (spoken and written), strong MS Office skills, knowledge of European pharmaceutical law and regulatory affairs.

• Ensure the pharmaceutical, medical, and regulatory accuracy of English product information (SmPC, Labeling, PIL) for European procedures (MRP, DCP, CP) of innovative, biosimilar and generic products.
• Provide internal pharmaceutical and medical expertise to address internal and authority-related inquiries and resolve labeling issues.
• Ensure regulatory compliance for all maintained innovative, biosimilar and generic EU procedures (MRP, DCP, CP) regarding labeling.

1. Labeling
• Responsible for creating and updating compliant English product information for EU procedures.
• Strategic planning and implementation of changes affecting multiple product information documents.
• Determination of an implementation plan and tracking the implementation of updates due to new requirements (e.g. new excipients warnings, QRD template update).
• Providing instructions and guidance to local RA (e.g. calculations due to new excipients warnings).
• Discussion of the content of product information for innovative products (pre- and post-approval) in project teams.
• Evaluate and approve change requests; coordinate submissions with EU regulatory units.
• Collaborate on patent-related issues with Global IP Group.
• Contribute to readability studies and ensure PIL readability and compliance with legal requirements.
• Adaption to reference medicinal product (generic, hybrid, biosimilar procedures).
• Preparation of Expert statements (justification) for type II variations.
• Providing scope of variation to regulatory affairs.
• Performing plausibility check and providing wording to be in line with QRD requirements and Standard Terms for module 3 updates.

1. Monitoring
• Monthly monitoring and communicating safety updates from EU authority websites.
• Track reference product updates and legal/guidance changes affecting product information.
2. Pharmacovigilance
• Assess need for updates based on Company Core Safety Information (CCSI).
• Implement PV triggered and non-PV triggered safety updates (e. g. PRAC/PSUSA/PSUFU, Referrals (Articles 31 + 107i), article 30 procedures, etc.) in line with SOPs; collaborate on safety-related actions with Pharmacovigilance and QA.
• Participation in Product Safety Group (PSG) Meetings.
• Implementation of internal signals (including determining PIL wording).
3. Scientific Work & Authority Communication
• Participate in project teams to fix the regulatory strategy and prepare expert statements.
• Respond to authority deficiency letters in collaboration with other departments.
4. Mockups
• Coordinate creation and approval of packaging mockups, Braille, and specimens.
• Address authority queries and ensure compliance with EU regulations.
5. Training
• Assist with training new team members

• Experience: 10+ years of total experience and minimum 6 to 7 years in relevant fields (medicinal information and EU labeling in the pharmaceutical industry) ideally in Regulatory Affairs.
• Education: Completed at least 8-semester university degree in natural sciences (e.g., Pharmacy [preferred], Biology, Human Biology, Medicine, Food Chemistry), preferably with a PhD.
• Other: Advanced English (spoken and written), strong MS Office skills, knowledge of European pharmaceutical law and regulatory affairs.

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.

• Ensure pharmaceutical, medical, and regulatory accuracy of English product information (SmPC, Labeling, PIL) for European procedures (MRP, DCP, CP) of innovative, biosimilar and generic products.
• Provide internal pharmaceutical and medical expertise for internal and authority-related inquiries and problem-solving.
• Ensure regulatory compliance for all maintained innovative, biosimilar and generic EU procedures (MRP, DCP, CP) regarding labeling.
• Support team members with complex issues as a senior expert (especially in responsibilities 2–6).
• Lead a team of academic staff and administrative staff handling EU Labeling and support departmental leadership.

1. Department Leadership
• Organize and coordinate departmental tasks, personnel management, and planning.
• Manage budget and resource planning.
• Establish efficient internal and cross-departmental processes.
• Lead projects related to labeling, including project management.
• Review and approve SOPs for the department and overall processes.
• Support division leadership and develop strategy, principles, and guidelines.
2. Team Leadership
• Organize and coordinate team tasks, personnel management and planning.
• Plan team activities and align with other teams.
3. Labeling
• Responsible for creating and updating compliant English product information for EU procedures.
• Strategic planning and implementation of changes affecting multiple product information documents.
• Determination of an implementation plan and tracking the implementation of updates due to new requirements (e.g. new excipients warnings, QRD template update)
• Providing instructions and guidance to local RA (e.g. calculations due to new excipients warnings).
• Discussion of the content of product information for innovative products (pre- and post-approval) in project teams.
• Evaluate and approve change requests; coordinate submissions with EU regulatory units.
• Collaborate on patent-related issues with Global IP Group.
• Contribute to readability studies and ensure PIL readability and compliance with legal requirements.
• Adaption to reference medicinal product (generic, hybrid, biosimilar procedures).
• Preparation of Expert statements (justification) for type II variations.
• Providing scope of variation to regulatory affairs.
• Performing plausibility check and providing wording to be in line with QRD requirements and Standard Terms for module 3 updates.
4. Monitoring
• Monthly monitoring and communicating safety updates from EU authority websites.
• Track reference product updates and legal/guidance changes affecting product information.
5. Pharmacovigilance
• Assess need for updates based on Company Core Safety Information (CCSI).
• Implement PV-triggered and non-PV-triggered safety updates (e.g. PRAC/PSUSA/PSUFU, Referrals (Articles 31 + 107i), article 30 procedures, etc.) in line with SOPs; collaborate on safety-related actions with Pharmacovigilance and QA.
• Participation in Product Safety Group (PSG) Meetings.
• Implementation of internal signals (including determining PIL wording).
6. Scientific Work & Authority Communication
• Participate in project teams to fix the regulatory strategy and prepare expert statements.
• Respond to authority deficiency letters in collaboration with other departments.
7. Mock-ups
• Coordinate creation and approval of packaging mock-ups, Braille, and specimens.
• Address authority queries and ensure compliance with EU regulations.
8. Industry Representation

• • Participate in working groups (e.g., Medicines for Europe) to represent the company as an EU labeling expert.

• Experience: 12+ years of total experience and minimum 8 years in relevant fields (medicinal information and EU labeling in the pharmaceutical industry), ideally in Regulatory Affairs with at least 3 years of leadership experience.
• Education: Completed at least 8-semester university degree in natural sciences (e.g., Pharmacy [preferred], Biology, Human Biology, Medicine, Food Chemistry), preferably with a Ph.D. Additional leadership qualification is preferred.
• Other: Advanced English (spoken and written), strong MS Office skills, excellent knowledge of EU pharmaceutical law, regulatory affairs, and related legal areas. Project management experience required.

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.