דרושים Manager Complex Gx Regulatory Affairs ב-טבע ב-India, Bengaluru

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.

• 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.

Business Unit Engagement & Partnership

• Act as the dedicated innovation partner to BU champions, guiding them in engaging stakeholders and surfacing high-quality innovation challenges.
• Translate BU needs into clear, structured challenge briefs aligned with business priorities.
• Serve as an advisor and facilitator, helping BUs navigate Teva’s innovation processes.

Process Management & Internal Alignment

• Own and manage the end-to-end internal innovation process: challenge definition, internal evaluation, solution assessment, pilot design, implementation, and integration.
• Coordinate across corporate functions (legal, IP, compliance, procurement, finance, etc.) to ensure alignment and remove internal barriers.
• Establish governance frameworks, playbooks, and best practices to streamline innovation workflows.

Pilot Implementation & Integration

• Support the design, execution, and monitoring of pilots in collaboration with BU stakeholders.
• Ensure pilots are structured for measurable outcomes, business relevance, and potential scale-up.
• Drive the transition from pilot to integration, ensuring successful solutions are embedded into BU processes, systems, and operations.
• Capture and disseminate learnings to build organizational innovation capabilities.

Organizational Enablement & Infrastructure

• Build the internal infrastructure (legal, compliance, IP, procurement frameworks) that enables efficient collaboration between Teva and external innovators.
• Proactively anticipate and address internal roadblocks, ensuring agility and speed in execution
• Act as a change agent, fostering a culture of collaboration and innovation across BUs.

• Bachelor’s degree in Business, Life Sciences, Engineering, or related field; advanced degree preferred.
• 6–10 years of experience in corporate innovation, strategy, consulting, or project management roles.
• Proven experience working across functions in complex, global organizations; pharma or regulated industries an advantage.
• Track record of driving cross-functional initiatives from conception to integration into business operations.
• Strong analytical and problem-solving skills with the ability to synthesize insights and guide decision-making.
• Exceptional project and stakeholder management skills, able to align diverse stakeholders toward common goals.
• Strong understanding of corporate functions (legal, IP, compliance, procurement, finance) and their role in enabling innovation.
• Excellent communication, facilitation, and influence skills at multiple organizational levels.
• Strategic thinker with operational rigor and the ability to balance creativity with process discipline.
• Comfortable operating in a global, matrixed environment with multiple priorities
• Travel required - 25%

Open Innovation Leader

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.

A Manager, in Global Regulatory Medical Writing, writes and edits clinical regulatory documents, including submission summaries and other complex documents, provides basic-level oversight and guidance, as well as resource management for the direct medical-writing support in the production of clinical research documentation used in drug development and product registrations.

• Primarily works at a project level.
• Writes and edits clinical regulatory documents including study reports, protocols, briefing books, investigator’s brochures, health authority responses, and other submission documents (e.g., module 2.5 and modules 2.7.x).
• Compiles, analyzes, and summarizes data from various sources.
• Conducts proofreading, editing, document formatting, and comment resolution.
• Ensures documents include the proper content and context (from a regulatory medical writing perspective) and clear and consistent medical/scientific messaging, are accurate and complete, and adhere to applicable regulatory guidelines and departmental and editorial standards.
• May participate in the preparation/revision of document templates and SOPs.
• May train and support medical writers or external vendors/contractors on document planning, processes, and content development.

• Bachelor's, Master's, MD, PhD, PharmD in life sciences (or other related field).
• Preferred Master's, MD, PhD, PharmD.
• University degree with a minimum of 5+ years of relevant experience; advanced degree preferred.
• Proficient as lead author writing protocols/protocol amendments, clinical study reports, investigator’s brochures, and clinical summary documents (modules 2.5 and 2.7.1-2.7.4)
• 6+ years with an advanced degree.
• Travel Requirements: Up to 10%

• 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.
• 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.
2. Monitoring
• Monthly monitoring and communicating safety updates from EU authority websites.
• Track reference product updates and legal/guidance changes affecting product information.
3. 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).
4. Scientific Work & Authority Communication
• Respond to authority deficiency letters in collaboration with other departments.
5. Mockups
• Coordinate creation and approval of packaging mockups, Braille, and specimens.
• Address authority queries and ensure compliance with EU regulations.

• Experience: 5 to 6 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)
• 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.

• 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.

The Associate II, Complex Gx, Regulatory Affairs is responsible for the preparation and submission of high-quality regulatory filings—both pre- and post-approval—for U.S. FDA-regulated sterile complex generic products. With moderate to minimal guidance, the Associate II will manage regulatory submissions—including original applications, amendments, deficiency responses, and postapproval supplements—while collaborating closely with cross-functional teams. The role includes evaluating change controls, determining appropriate regulatory pathways (e.g., PAS, CBE-30, CBE-0, AR), confirming the change assessment with their regulatory manager, and submitting post-approval supplements in accordance with FDA guidelines and internal SOPs. The Associate II, on occasion, will also serve as a regulatory point of contact for assigned products and contribute to process improvement initiatives.

• With moderate to minimal guidance, prepare, review, and compile new submissions, deficiency responses (IRs, DRLs, CRLs), and amendments using the "Right-First Time" approach.
• Work with their manager to support early FDA engagement to align on development strategy, reduce regulatory risk, and support first-cycle approvals.
• Support regulatory assessments and decision-making for significant changes, including site transfers and alternate API sourcing.
• On occasion, serve as regulatory contact point for cross-functional teams like R&D, QA, Manufacturing & Packaging sites, DMF holders, etc.
• Monitor and manage regulatory timelines and proactively address data or document gaps.
• Evaluate and classify change controls for regulatory impact and determine appropriate submission pathways.
• Compile and submit post-approval changes (PAS, CBE-30, CBE-0, AR) ensuring compliance with FDA, ICH, and internal requirements.
• Track regulatory guidance updates, stay current with evolving regulatory requirements.
• Monitor relevant FDA databases (e.g., Drugs@FDA, Orange Book) and ensure internal stakeholders are informed of critical changes.
• Participate in audits, inspections, and process improvement initiatives.

• Master’s degree in RA/QA discipline, preferably in Pharma.
• Minimum 4+ years pharmaceutical industry experience with sterile products; Regulatory, Analytical, QA, laboratory or production experience preferred.
• Demonstrates an understanding of ICH and FDA guidelines
• Demonstrates excellent verbal and written communication skills.
• Demonstrates excellent organization skills and the ability to multi-task; detail oriented.
• Possesses strong critical and logical thinking.

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.