דרושים Associate Director Country Procurement Head - Tapi ב-טבע ב-הודו

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.

Regulatory Affairs associate I – RA publishing will participate in the publishing of different regulatory activities. The focus will be to ensure 100% quality and timeline of the submission. This role will be the primary interface with the Regulatory Affairs Associate

• Publish and dispatch major and complex routine/lifecycle management eCTD submission projects for EU, US and Canada.
• Exposure in handling post approval submissions publishing and transmitting quality submissions to agency.
• Perform document level publishing activities, troubleshoot document issues and perform quality control checks for submission ready documents as per the agency guidance.
• Collaborate with scientific personnel for planning, preparation and publishing
• Maintain working knowledge of internal and external publishing standards.
• Basic knowledge of ICH and eCTD related specification/guidelines governing regulatory submissions (eCTD, NeeS, paper)
• Must be aware of technical systems like Global Insight, Veeva Vault, ISI Toolbox, Adobe Acrobat, Lorenz Validator

• B. Pharm/M. Pharm/ Master of Life Sciences.
• Total years of experience required for the role: 1-3 years (if any, preferred Regulatory Publishing experience in EU and US market)
• Command over spoken and written English
• Sensitivity to the cultural diversity of a global organization
• Good understanding of regulatory IT systems

Manager – Regulatory Submission Management

• 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.

The role of the RIM team is to:

• Develop and implement the RA business systems strategy required to ensure that Global Regulatory Affairs (GRA) systems continue to meet ongoing and emerging business needs.
• Provide the expert business analysis input required for the successful development of strategic system roadmaps and for the successful implementation of the projects required to ensure the delivery of the technology solutions required to support the GRA business and its partner functions.
• Provide RA Business Data Administration and Business System Ownership, including system and data related business change management, in support of the RA business process and data requirements, and compliant system usage.
• Partner with external pharmaceutical industry stakeholders (e.g. industry associations) and health authorities to influence outcomes relating to emerging requirements such as ISO IDMP and FMD etc.
• Manage and deliver the Teva XEVMPD submissions related to Investigational Medicinal Products, review and remediate Authorized Medicinal Products 3rd acknowledgment and EMA follow up reports to ensure Article 57 compliance.
• Support PV in case of audits and inspections, provide Teva XEVMPD records EV web reports, review and/or remediate the Teva xevmpd records (if required) including collaboration on CAPA plan in case any finding is related to RIM/xevmpd data
• Support the in-house Regulatory Data Administration team for the management of Teva registration data. This includes support for data integration and data integrity/enrichment initiatives to ensure compliant and reliable RA data for accurate reporting and business decisions making.

TheRIM Business Analyst/Project Managerwill support and enable the successful execution of this role.

• Responsible for supporting effective business project management for regional and global projects focused on improving regulatory data quality, the provisioning of regulatory data for internal re-use via system integration, or the implementation of any business or technology change that impacts regulatory data and documents or the regulatory technology landscape.
• Required to lead cross-regional and cross-functional projects teams, working and influencing staff at all levels within the organization to ensure regulatory systems, and related processes, are developed and enhanced to meet the diverse regulatory business process and data requirements.

The
RIM Business Analyst/Project Managerwill work closely with the Harlow based RIM and GRO Regulatory Data Administration teams. Will work closely with the GRA functional teams dependent upon these operations. Will act as change manager, and/or escalation point for these operations to ensure their continued effectiveness, and to ensure GRA business needs continue to be met by these operations.

• They will be an effective Business Analyst, responsible for deep dives in to current and mapping future business process, be expert in interrogating regulatory legislative and guidance documents and draw on that expertise to shape the to-be processes to ensure business compliance.
• Responsible for providing effective Business Data Administration oversight for GRA data (e.g. for the data management/data quality decisions that impact system dictionary-controlled values and for defining, obtaining agreement to, and communicating, GRA data process related work instructions etc.)
• Must be fluent with Pharmaceutical Regulatory Affairs business processes.
• Must leverage deep regulatory business expertise to successfully partner with Regulatory Affairs functional/strategy teams, and IT etc.
• Must understand evolving regulatory requirements and guidelines.
• Must be able to understand and define new RA business requirements, translate those into strategic project proposals for change and to deliver those projects.
• Must be analytical, methodical, and able to successfully analyse data, process, and external regulatory requirements.
• Must be a highly effective communicator, capable of relaying complex concepts to all levels and functions of the company.

Qualfication:

• Required: Bachelor’s Degree in Life Sciences or Information Technology
• Preferred: MS in scientific or information technology discipline

Required:

• 3 to 5 demonstrable experiences of the pharmaceutical industry with direct experience in Regulatory Affairs.
• Demonstrable experience of leading cross-functional project teams and change projects, including working within a multifunctional/geographical matrix.
• Demonstrable experience of analysing the data requirements of RA business processes and of managing regulatory data in line with the high standards required to maintain regulatory compliance and to support the growing RA business data demands.

Preferred:

• Extensive experience of the pharmaceutical industry with direct experience in Regulatory Affairs.
• Extensive experience of leading cross functional project teams and change projects, including working within a multifunctional and geographical matrix.
• Extensive experience of analysing the data requirements of RA business processes and of managing regulatory data in line with the high standards required to maintain regulatory compliance and to support the growing business process data demands.
• Experience with Parexel/Liquent’s Insight/Veeva regulatory information management suite of products.

• Knowledge of global (FDA, EMA, Health Canada and Japan) regulatory requirements.
• Knowledge of global industry initiatives and direction.
• Knowledge of industry regulatory standards (eCTD, CDISC, EVPRM, SPL, ISO IDMP, SPOR, RIM systems etc).
• Understanding of regulatory business processes: regulatory submission, CMC, product strategy, registration/regulatory data management..
• Understanding of the drug development process for generics, branded, and Non-Med product development a plus.
• Working knowledge of system and business process design and implementation a plus.

Sr Manager, RIM, Global Regulatory Operations

The Associate III, with minimal to no guidance, prepares, reviews and submits high quality regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines. The Associate III will be responsible for independently evaluating change controls (intended for post approval changes), will assure the CC is complete and accurate and in the absence of any comments will progress the CC accordingly. In addition, he/she will monitor any/all Regulatory or team databases and trackers and will proactively and accurately update them when changes are required. Annual Reports, supplements, post approval submissions and assisting management with the training of regulatory staff will be the primary responsibilities of the Associate III.

• Maintain approved applications in compliance with FDA regulations for assigned ANDA Annual reports.
• Independently and proactively request documentation required for annual reports, compile, finalize and publish for managements review and subsequent dispatch to the Agency
• Independently work on supplements, compile and publish for managements review. Take a proactive approach for more complex submissions and contact internal stakeholders (when needed) to gain further insight on any given supplement. Convey findings to management and incorporate any.all applicable information in the submission to ensure a quality and a right first time submission.
• Assist management and proactively train Associate I’s and Associate II’s on guidance’s, internal processes, procedures, databases and trackers
• Other projects and duties as required/assigned.
• Process improvement

• M. Pharma degree in RA/QA discipline, a plus.
• Minimum 5+ years pharmaceutical industry experience; Regulatory, Analytical, QA, laboratory or production experience preferred.
• Demonstrates an understanding of ICH and FDA guidelines
• Demonstrates the ability to evaluate regulatory documents and determine appropriate action.
• 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.

Position responsibilities include Quality oversight for Manufacturing, Packaging and Laboratory Operations to ensure a mature culture of quality, compliance with regulatory requirements and quality of products.

This oversight includes but is not limited to the establishment and execution of procedure; Establishment Licensing, Quality on the Floor activities including audit and release; handling of laboratory, deviation and complaint investigations; CAPA Creation and implementation; trending and metrics, compliance with validation requirements; verification that equipment, facility and utility systems are maintained in accordance with established requirements.

Lead the development, standardization, implementation, monitor effectiveness and continuous improvement of Quality Systems, global and local compliance programs, industry practices, and corporate quality initiatives. Influence quality and compliance initiatives to implement robust and proactive process improvement programs within a strong quality culture to align and demonstrate compliance to Good Manufacturing Practices

• Leads the Quality organization on site including Quality Control, Microbiology, Quality Compliance, Quality Systems and Quality Assurance Operations.
• Ensure a current Quality Management System is in place and continuously improved
• Ensure products are manufactured, released and distributed in accordance to cGMP requirements and registered specifications.
• Most senior professional and independent decision maker authority on product quality and potential market actions
• Assess and Mitigate Risks-- Identify quality risks and define proactive mitigations, to ensure the products are safe and effective before they reach the market. Work with the business to assure compliant and reliable supply
• Design and Implement the Site Quality Program—Collaborate with the Site GM and Corporate Quality to create, implement, monitor and update the site quality program.
• Manage Quality Data--Oversee the delivery of necessary data to site managers and supervisors, Corporate Quality and other internal and external stakeholders, to support the achievement of Quality objectives and ensure compliance
• Direct Quality Control-- Oversee the laboratory activity, including analytical site transfers, testing and approval or rejection of raw materials, packaging materials, in process materials and finished products for the site
• Promote a Sustainable Culture of Quality---Create, develop and maintain a culture of enhancing quality throughout the entire site operation. Create a space where people can speak openly and are encouraged to present new ideas to improve quality
• Maintain strong partnership with site leadership team
• Strategic partner in the site leadership team, with Supply Chain, Project Management, R&D, MS&T and Commercial to ensure project timelines and objectives are met
• Provide effective Quality leadership during internal, customer and Health Authority inspections
• Ensure that Quality KPIs are meeting pre-defined targets, Ensures CAPA commitments are implemented in a timely manner and its effectiveness is monitored periodically
• Plans, manages and monitors the annual Quality Operations budget and all its resources and employees. Ensure the performance and utilization of resources to provide maximum efficiency to the organization.

• Required – bachelor’s degree in chemistry, Biology, Pharmacy
• Preferred - Master or equivalent degree in Chemistry, Biology or Pharmacy

Key Requirements:

• Minimum of 10 years pharmaceutical manufacturing site quality operations and leadership experience, including:
  • Deep knowledge of cGMP requirements of local and major international authorities like EMA and US FDA for products and process,
  • High level of understanding of manufacturing, packaging, technology transfer, cGMPs, EU, ICH guidelines as well as CMC content of regulatory submissions,
  • Deep knowledge of chemical/pharmaceutical production operations/ lifecycle, production equipment/ validation and relevant technologies and product types,
  • Strong understanding and experience in Data Integrity and Compliance
  • Experience preparing and/ or leading regulatory authority GMP
  • Deep knowledge of Quality Systems
• Proven successful track record of leading organizational change to improve efficiency
• Experience leading, inspiring and coaching large teams
• Experience developing and implementing and continuously improve existing and new, efficient, and effective business processes
• Must have adequate knowledge of Quality best practices
• Must have adequate practical knowledge of pharmaceuticals manufacturing and/ or control
• Must have adequate practical knowledge of analytical techniques and microbiological principles
• Must have practical knowledge of pharmaceutical cross functional operations (e.g., Supply Chain, Engineering), product and tech transfer
• Must have practical knowledge on lean manufacturing/ lean QC and OPEX tools
• Good knowledge of environmental, health and safety requirements for laboratories and quality operations.

This role oversees Total Rewards activities in Israel

• Design and execute Compensation cross company programs in alignment with Teva Total Rewards philosophy and approach.
• Lead end to end Year-End Rewards process which includes Merit, Bonus, Promotions and Equity
• Lead the annual compensation review to provide inputs to the AOP, including benchmark approach, market competitiveness and identify special needs to support the business
• Total Rewards focal point to advice IL HRDs / HRBPs, working closely with unions
• Design and govern benefits programs such as medical, pension, car and more
• Support Health & Wellbeing initiatives leveraging local and global best practice

Qualifications:

• Mastering the C&B various methodologies, global processes and programs, as well as familiarity with the current and future trends in the Rewards arena
• Ability to run global and complex programs and process
• Strong quantitative analytic capabilities
• Excellence in execution - the ability to resolve complex issues and complete multiple tasks within agreed timelines
• Excellent Collaboration, influencing and interpersonal skills

Experience:

• Bachelor or Master degree in Business, Economy, Statistics, Human Resources or related field
• 7+ years experience of C&B (e.g. annual pay processes, surveys benchmark, salary review processes, benefits program design)
• Experience in working with financial concepts (P&L, cost centre management, accruals)
• Experience in project management and major initiatives implementation
• Familiarity with Equity based on programs (Advantage)

Sr Director - Total Rewards International Markets

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.