דרושים Regulatory Affairs Associate ב-טבע ב-India, Navi Mumbai

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

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.

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.

• To organize and perform required regulatory tasks in order to maintain existing EU procedures in line with current regulations, guidelines and in-house standard
• To obtain regulatory approvals for defined European procedures, ensuring high quality data and standards are used in all regulatory application
• To ensure high quality documents and standards are used in preparation of all regulatory applications to achieve rapid and successful assessment.
• To give regulatory support to project teams, stakeholders and other sites, as require

• Prepare, compile, review and submit high quality submissions for all required post-approval activities in accordance with EU legislation and in-house standards.
• Responsibility for MA compliance with both legislation and business needs.
• Prioritise, plan and monitor submissions for allocated procedures while documenting and informing involved parties of progress.
• Ensure approvals are secured within the stipulated timelines for designated projects.
• Maintain registration documentation and associated electronic databases, in line with in-house procedures.
• Provide regulatory support and product information for all internal and external customers, stakeholders and TEVA project teams.
• Communicate with other Teva departments across Europe and European Agencies regarding proposed and pending submissions.
• Maintain and develop awareness of current/pending regulatory legislation and guidelines.
• Fulfilling other allocated department duties and ad-hoc needs at the direction of Senior Regulatory Affairs personnel.
• Awareness of regulatory legislation and guidelines

Required Degree: Master in Pharmacy or Master in science/life sciences

Experience:

• Total years of experience required for the role: 2 to 3 years in Post approval Regulatory affairs
• Overall Pharma industry experience: 2 to 3 years
• Desirable to have EU experience and knowledge of European regulatory procedures.

• Desirable to have EU member state experience and knowledge of European regulatory procedures.
• Understanding of processes and departments within a pharmaceutical company.
• Excellent oral and written communication
• Ability to work under pressure and to tight time deadlines
• Effective time and organisation management
• Negotiation
• Initiative
• Analytical (Data and Documentation)
• Computer literacy
• Teamwork and collaboration
• Attention to detail
• Planning and Organisation

• To organize and perform required regulatory tasks in order to maintain existing EU procedures in line with current regulations, guidelines and in-house standard
• To obtain regulatory approvals for defined European procedures, ensuring high quality data and standards are used in all regulatory application
• To ensure high quality documents and standards are used in preparation of all regulatory applications to achieve rapid and successful assessment.
• To give regulatory support to project teams, stakeholders and other sites, as require

• Prepare, compile, review and submit high quality submissions for all required post-approval activities in accordance with EU legislation and in-house standards.
• Responsibility for MA compliance with both legislation and business needs.
• Prioritise, plan and monitor submissions for allocated procedures while documenting and informing involved parties of progress.
• Ensure approvals are secured within the stipulated timelines for designated projects.
• Maintain registration documentation and associated electronic databases, in line with in-house procedures.
• Provide regulatory support and product information for all internal and external customers, stakeholders and TEVA project teams.
• Communicate with other Teva departments across Europe and European Agencies regarding proposed and pending submissions.
• Maintain and develop awareness of current/pending regulatory legislation and guidelines.
• Fulfilling other allocated department duties and ad-hoc needs at the direction of Senior Regulatory Affairs personnel.
• Awareness of regulatory legislation and guidelines

Required Degree: Master in Pharmacy or Master in science/life sciences

Experience:

• Total years of experience required for the role: 2 to 3 years in Post approval Regulatory affairs
• Overall Pharma industry experience: 2 to 3 years
• Desirable to have EU experience and knowledge of European regulatory procedures.

• Desirable to have EU member state experience and knowledge of European regulatory procedures.
• Understanding of processes and departments within a pharmaceutical company.
• Excellent oral and written communication
• Ability to work under pressure and to tight time deadlines
• Effective time and organisation management
• Negotiation
• Initiative
• Analytical (Data and Documentation)
• Computer literacy
• Teamwork and collaboration
• Attention to detail
• Planning and Organisation

Responsible for leading and managing applications through the regulatory approval process, including preparation of Post Approval Submissions to Health Canada (HC), to obtain timely approvals. Work independently as a professional and keeps management informed of significant regulatory issues that affect assigned products/projects.

• Prepare, compile, review and submit high quality submissions for all post approval activities in accordance with Health Canada Regulations and corporate standards.
• Support the development and implementation of regulatory strategies for defined projects until approval and launch as applicable.
• Interface with R&D and other business functions on a regular basis to ensure project-specific regulatory strategy is met as agreed in timely manner
• Responsible for evaluating change controls for regulatory filing assessments in accordance with HC guidance documents. Subsequently prepare and ensure all timely post approval regulatory activities, as applicable.
• Keep current with the Teva work procedures, Health Canada Regulations/ Guidance as well as ICH regulations
• Business development assessments as applicable
• Other projects and duties as required/assigned

• M. Pharma degree in a scientific discipline
• Minimum 5-7 years in Regulatory affairs in post approval (EU/FDA with preference for HC) and overall pharma experience of 7-10 years
• Preferred, experience with sterile products.
• Excellent oral and written communication
• Excellent organizational skills and the ability to multi-task; detail oriented.
• Possesses strong critical and logical thinking