Regulatory Affairs Associate Iii Labeling jobs at Teva in India, Bengaluru

• Develop and execute global product strategies, including launch planning, lifecycle planning, and indication and geographic sequencing in line with the IDP
• Align global forecasts, TPPs, and clinical endpoints to ensure strategic coherence
• Translate clinical and scientific data into compelling value propositions and messaging in partnership with the Global Pricing, Value & Access team
• Responsible for global brand strategy efforts, including core global campaign and content delivery
• Lead the annual brand planning process (3 year time horizon), ensuring clarity and consistency across regions for key global brands
• Partner cross-functionally with Regional Commercial Teams, R&D, Medical Affairs and Business Development to prepare for, and guide portfolio decisions and evidence generation through stage gates and governance.
• Support BD evaluations with strategic fit assessments and commercial opportunity framing in line with the Neurology Disease Strategy.
• Drive global launch readiness and market expansion, collaborating with regional and affiliate teams, identifying market opportunities including geographies and indications
• Collaborate on supply chain strategies to optimize profitability, CoGs and returns
• Oversee and direct market insights work, competitive intelligence, and performance tracking (KPIs) to inform strategy
• Engage with KOLs, advocacy groups, and external stakeholders to shape brand perception
• Build and lead a high-performing global team and cross functional partners, fostering innovation and accountability with a strong “outside in” perspective
• Demonstrated outstanding storytelling and leadership engagement under pressure.
• Ability to navigate ambiguity and drive alignment across global and regional stakeholders
• Strategic Global Commercial leadership for assets outside of the Immunology and Neuro portfolio e.g rare disease.

• Bachelor’s degree required; Master’s degree or other advanced degree a plus.
• 20+ years experience as a commercial leader with exceptional track record of delivering at scale with proven results and leadership impact
• Significant Commercial Leadership role, with a large span of control; P&L accountability (e.g GM or Business Unit Head or Head of Sales and Marketing Division) within the last 5 years
• Experience with US Market and/or large market (e.g. EU 5) experience required
• Experience working across multiple therapeutic areas - Neuroscience preferred

• Experience in a global role, and understanding the relationship between global functions, and the markets.

Skills/Knowledge/Abilities:

• Deep understanding of the neurology market
• Ability to positively influence cross-functional enterprise stakeholders at all levels of the organization
• Demonstrated consistent success in building and developing high-performing teams across regions
• Recognized as an enterprise commercial leader by the business inside and outside of Teva

• Performs broad range of work and complex activities with substantial autonomy
• Sought out by others for guidance
• Leads and develops others

TRAVEL REQUIREMENTS:Approximately up to 30% travel to support key meetings and cross-functional planning

We offer a competitive benefits package, including:

• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.

SVP Global Product Strategy- Innovation Medicines

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 incumbent will perform development in SQL Server, Data Bricks and other related applications. The Application Developer will also deliver, and/or support the delivery of, projects/initiatives related to the Value and Access domain, resolve operational issues, ensure the application’s integrity and availability to sustain day to day operations with a focus on the application’s interfaces and integrations.

• Technical Delivery: Serve as the Technical and Subject Matter Expert responsible for solutions delivery and support of Value and Access solutions and systems interfaces. Lead technical design and requirements gathering. Develop technical documents and provide architectural recommendations and design guidance across Value and Access solutions and technologies, ensuring solutions are sustainable and meet technical standards. Design and develop high quality and scalable application code using REACT UI, SQL, PL/SQL, Python, Unix shell scripting, etc.
• Develop Business Relationships: Create effective relationships with business stakeholders to ensure expectation management and alignment of team priorities with the business.• IT Improvement and Innovation: As an IT individual contributor, the incumbent is expected to contribute independent ideas, proposals, and projects for improving the efficiency, effectiveness, and value of IT at Teva.
• Sustain Operations: Support the business stakeholders in their day-to-day operations providing the highest levels of service and maintaining a stable operating environment. Coordinate with infrastructure, IT Security and other internal, IT support functions to maintain system stability while minimizing business impact of routine and non-routine IT maintenance activities. Work to resolve issues and ensure the application’s integrity and availability to sustain day to day operations with a focus on the application’s interfaces.
• Follow Teva Safety, Health, and Environmental policies and procedures.
• Other projects and duties as required / assigned

• Must have a bachelor’s degree in computer science or a related filed
• 7+ years’ experience working as a backend or full stack developer with experience in SQL Server, Databricks or React UI
• Experience with IT in Pharma preferred.
• Proficiency in SQL Scripting and experience with complex queries, stored procedures and performance optimization techniques.
• Experience working with commercial pharmaceutical data (IQVIA, MMIT, Fingertip, Medicaid, Patient Data, etc.)
• Experience working in global cross functional teams preferred
• Strong understanding of data warehousing concepts, data modeling and database design principles
• Must possess Strong analytical and problem-solving skills
• Must have strong experience supporting complex, multi-system, end-to-end integrations in a dynamic production environment with ability to troubleshoot across systems.
• Must possess good communication skills and be able to convey technical concepts to a non-technical audience.

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.

Providing regulatory support for International Markets RA.

• Completion of designated projects and tasks supporting International Market RA, according to internal Work Instructions, with guidance and direction by the manager and more senior colleagues.
• Maintaining related documentation and regulatory IT systems, in line with internal procedures.
• Timely task completion in line with Work Instructions, with accurate tracker updates and adherence to compliance standards.
• Communication with Teva units across International Markets, with 3rd Parties and with related Health Authorities.
• Fulfilling other allocated department duties and ad-hoc tasks as directed by senior regulatory affairs staff.
• Completion of trainings assigned in Teva internal learning management system within defined timeframes.
• Attending team meetings and providing regular updates on the assigned activities and tasks to the manager and/or to senior regulatory affairs staff.
• Maintaining and developing awareness of the current/pending regulatory legislation and guidelines.

Qualification:

• Masters in Pharmacy or Masters in Science/Life Sciences
• College or University degree or equivalent work experience that provide knowledge of and exposure to fundamental theories, principles and concepts.

Experience:

• 2-3 years of experience in the Pharmaceutical Industry, ideally within Regulatory Affairs but R&D, Development or QA would be considered.
• Experience of regulatory documentation within Europe and/or International Markets.

• Work experience involving core regulatory concepts and procedures.
• Ability to use existing internal procedures to solve routine or standard problems.
• Proficient in regulatory IT systems to support compliance and documentation processes.
• Working knowledge of Office-365 applications and Veeva Vault systems.
• Strong focus on Compliance and regulatory standards.
• Basic knowledge of project management principles and tools.
• Strong organizational skills to meet self, team and company goals.
• Ability to identify a problem or need for decision that exceeds the competence of the individual.
• French and/or German language proficiency will be an added advantage.

• Perform initial problem determination (level 1) in support of scope of services with related hardware, software and services support.
• Provide in-scope technical advice and guidance, trouble shoot end users queries / issues and advise potential resolutions within specified KPIs and metrics.
• Handle service entitlement failures associated with requests for in-scope services.
• Assign records to other support groups, as and when required.
• Act as service desk's advocate when dealing with other support / resolver groups.
• Initiate the service outage procedure, update VRU status messages with outage information, as required.
• Process requests for password resets and manage the requests to satisfactory completion.
• Accurately log all interactions via established business processes and tools.
• Understand and contribute to the improvement of various performance metrics.
• Update inventory for software licenses, hardware and reporting.

• 1 -2 years' experience as a technical service desk agent
• Excellent logical reasoning, troubleshooting and problem determination skills
• Strong communication (verbal and written) skills
• Knowledge and experience with Remote takeover tools.
• Work in office is required (No work from home option)

First Line Manager

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.

• Monthly review of Health Canada brand safety updates.
• Align updates with internal product lists and communicate relevant changes to cross-functional teams.
• Strategize and implement changes impacting multiple product documents.
• Track and retrieve the latest innovator PMs from the Health Canada Drug Product Database.
• Create and update Teva PMs by referencing Canadian innovator products.
• Use tools like TVT for document comparison, ensuring compliance with HC master templates.
• Perform thorough QC, editing, formatting, and coordinating the review and approval processes.
• Collaborate with French translators for bilingual PMs.
• Coordinate with artwork team the creation of packaging components (Inserts/Outserts/Cartons/Labels) for sANDS submissions.
• Manage the Veeva Artwork Process to obtain final artworks.
• Conduct quality reviews of labeling and submission documents using manual proofreading and electronic tools (TVT).
• Support other safety Level III updates and regulatory commitments in collaboration with the Canada RA team.
• Address Health Canada queries including clarifaxes, screening acceptance, pause-the-clock requests, extensions, BA/BE queries, and withdrawals.
• Maintain accurate project trackers to monitor due dates, priorities, and timelines for all assigned projects.
• Keep databases updated and share current PMs and relevant details with internal and external stakeholders.
• Collaborate with the RA Canada team on safety-related submissions such as Advisement Letters and Level III changes.
• Ensure timely eCTD-compliant submissions in coordination with Regulatory Operations and publishing software.
• Stay current with Health Canada regulations, guidelines, and SOPs.
• Work effectively in a team environment with minimal supervision.
• Perform additional job-related duties as required by management and evolving processes.

• Pharma Graduate / Post Graduate with a Scientific or Regulatory background or equivalent combination of education and experience
• 3+ years of experience in Regulatory Affairs with a focus on Canadian labeling.
• Knowledge of Health Canada regulatory requirements related to Canadian labeling
• Knowledge of XML/SPM development and Health Canada requirements.

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.

• Technical/functional knowledge in Accounting and fixed asset closing area
• Ensure that capitalization, maintenance, depreciation, amortization are properly recorded and analyzed
• Very well verse with lease accounting concept
• Preparation of Journal Entries, Supporting schedule & Roll forwards
• Perform monthly and quarterly FA closing activities of multiple entities
• Analysis of the various fixed asset accounts and variances per legal entities, obtain explanation on deviations and prepare a summarized reporting on a monthly basis within scheduled time
• Preparation & clearance of open reconciling item in account reconciliations
• Hands on experience in submission of trial balance in HFM
• Identify & drive standardization opportunities in processes and tasks across the team
• Acting as a key contact for local teams for fixed assets and lease related questions
• Ensuring that accounting books and records comply with accounting policies and regulations
• Provide supporting documents and explanations for all internal and external audit as and when required
• Participate in ad-hoc activities and projects

• University education in Accounting or Finance required
• Minimum experience of 3+ years into managing fixed assets & leases register for large scale organization
• Preferably familiar with US GAAP
• Working knowledge of internal controls
• Good working knowledge of SAP
• Good understanding of accounting processes and can follow accounting policies
• Good analytical skills and have hands on experience in Fixed asset as well as Leases process
• Fluent verbal and written communication in English
• Experience in a multinational firm or within a GBS (Global Business Services) is preferred
• Hands-on and proactive; strong organizational skills
• Accustomed to working with deadlines, in a dynamic environment
• Results driven and service oriented to internal and external customers
• Excellent collaboration with colleagues within the local organization and with the colleagues of the global business service to support the overall Finance department’s goals and objectives
• Flexible and able to work in a changing environment
• Strong focus on improvement opportunities
• Want to work in a new (to be) established team
• Process documentations and certifications – will have to ensure that all process are appropriately documented and periodically certified by team members on regular basis

Group Leader Financial Operations

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.

• Bachelors in Computer Science or related degree
• 5 to 10 years Relevant ServiceNow developer experience
• Business Communication and strong knowledge on SDLC process
• Good control on ServiceNow core development concepts:
• Strong ServiceNow base structure knowledge (table dictionary. etc.)
• Update sets
• Client side and Server-Side scripts and associated concepts. Strong knowledge on scripting.
• Good control in integration concepts
• Having good knowledge on Automation activities.
• Strong knowledge on service catalogs workflows flow designer and automating flows.
• Service Portal Knowledge (Agent workspace is optional but preferable)
• Implementation knowledge on ITSM and NON ITSM modules. (Non ITSM modules includes HRSM, CSM, GRC, Facility…etc.).