דרושים Accounting Admin Ii ב-טבע ב-India, Bengaluru

• 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.

This incumbent

• Ensures that the review of CMC documentation is completed in timely & compliant manner as per Teva CORP standards and related Guidance’s.
• Review of Method Development/Validation Protocols & Reports, Stability Protocols & Reports received from various Teva contracting sites, R&D units, Method Development & Stability Testing Centres.
• Review of Instrument/Equipment Qualification records.
• Review of BMR.
• Ensures that the Product Quality Reviews / Annual Product Reviews for Teva products are completed in a timely and compliant manner as per Teva’s CORP Quality Management systems. PQR/APR compilation and approval must be well associated with the Teva Manufacturing Sites, Global Quality Units and Commercial affiliates to meet the targets and ensure compliance.
• Compilation of high quality Annual Product Reviews (APRs) / Product Quality Reviews (PQRs) for products manufactured at various manufacturing sites and retrieve data from the Quality and regulatory databases and system
• Liaising with third party contract manufacturers and QA/QC/Technical support personnel located globally for data collection and arranging responses.
• Recommend actions and professionally communicate to sites/ Quality units for continuous improvement in quality of products
  Receives guidance from Supervisor, Group Leader, Manager Global Quality Services, Associate Director Global Quality GBS, other Managers in Quality Strategy & Shared Services, EMSO Quality affiliates, Commercial Quality EU & IM, TGO sites

1. Review of CMC Documentation

• Review of Method Development / Validation protocols & reports.
• Review of Stability Study protocol, reports & grids.
• Review of Instrument / Equipment Qualification records.
• Review of Batch Manufacturing Records.
• Liaising with contracting Teva units and QA/QC personnels located globally for arranging required documents and query responses.
• Escalation of issues to Supervisor, Group Leader, Manager Global Quality GBS.
• Contemporaneous updation of SharePoint data base

1. Data requesting and Compilation of PQR’s

• Compilation of high-quality Annual Product Reviews (APRs) / Product Quality Reviews (PQRs) for products manufactured at various manufacturing sites and retrieve data from the Quality and regulatory databases and systems
• Liaising with third party contract manufacturers and QA personnel located globally for data collection required for compilation of APRs/ PQRs.
• Follow up with the CMO‘s for the receipt of data within time.
• Check quotation received from CMO and initiate PR/PO for QP’s approval.
• Once the data is received responsible for filling the PQR receipt checklist and scheduling the PQR in SharePoint.
• Escalation of PQR issues to Supervisor, Group Leader, Manager PQR Centre.
• Contemporaneous updation of SharePoint data base

1. Quality Management Systems

• Initiate the process of change controls and deviations
• Preparation of local SOP’s and its related documents.
• Participate in self-inspection process

1. Performance Management

• Participate in continuous process improvement projects to improve efficiency of the unit

1. Training

• Prepare the Training Materials for GMP training and on the job training.
• Imparts training on procedures as needed.

1. Miscellaneous Support

• Any other tasks assigned by the management for smooth functioning of the team

• 2 to 8 years of experience in QA / QC function in the pharmaceutical industry
• Master’s Degree in Pharmacy or other natural sciences or Bachelor Degree in Pharmacy or other natural sciences
• Basic knowledge on worldwide cGxP regulations
• Good English language skills, other language skills could be helpful
• Good communication skills
• Basic knowledge of Computerised Systems. Knowledge of Systems in TEVA´s IT landscape (TrackWise, SAP, LIMS, Global Insights, Glorya etc.) would be of advantage
• Basic understanding of manufacturing, QC and Contract manufacturing processes
• Engagement to drive improvements and ability to manage complexity
• Hands-on experience on Analytical Method development, Method Validation for API and FP of different analytical methods (e.g. Assay, impurities, dissolution etc.) & Stability Studies.
• Hands-on experience on Review of Instrument/Equipment qualification records.
• Basic knowledge / hands on experience of review of BMR.
• Basic knowledge / hands on experience on Product Quality Reviews.

The following areas of responsibility are essential to the satisfactory performance of this position by any incumbent, with reasonable accommodation if necessary. Any nonessential functions are assumed to be included in other related duties or assignments.

• Build rapport and relationships by interacting effectively with regional team members and key external contacts (ie, HCP and entire office staff) at all levels, demonstrating the awareness of their needs and responding with the appropriate action
• Provide healthcare product demonstrations, physician detailing, and in-servicing of products to current and potential customers
• Consult with physicians, nurses, and medical office staff to appropriately promote product and provide product and patient education
• Strategically manage and grow relationships with key accounts by tailoring solutions to meet their unique needs, leveraging industry insights to drive product differentiation and achieve sales targets
• Regularly review and analyze all provided sales data in order to create effective territory plans and utilize promotional budget funds
• Maintain a competitive edge by effectively addressing external market challenges while fostering a collaborative environment with internal teams to drive cohesive and successful sales strategies
• Open to working with cross-functional teams to integrate diverse expertise and insights and achieve shared objectives
• Maintain a call average as outlined in the sales plan, defined as face-to-face interactions, with healthcare providers focusing on top target customers
• Take calculated risks and apply a range of traditional and nontraditional problem-solving techniques to solve issues creatively in order to improve performance in geographical assignment
• Adhere to all Teva’s compliance policies and guidelines
• Achieve all sales performance goals, reach objectives, and complete all administrative duties for geographical assignment

Any equivalent combination of education, training, and/or experience that fulfills the requirements of the position will be considered.

Education/Certification/Experience

• Bachelor’s degree required, preferably in related field
• At least 1 year of full-time, documented business-to-business sales experience; pharmaceutical sales experience strongly preferred

Skills/Knowledge/Abilities

• Proven record of accomplishments in this specific market toward meeting established objectives
• Demonstrated interpersonal skills, including active listening, empathy, open communication, inclusivity, and openness to feedback
• Well-developed written and oral communication skills
• Ability to interact with HCPs in both face-to-face and virtual environments, and be proficient with technology
• Knowledge of reimbursement, managed care, or marketing preferred
• New product launch experience preferred
• Broad therapeutic area experience particularly in therapeutic area preferred
• Candidate must be able to successfully pass background, motor, and drug screening
• Valid US driver’s license and acceptable driving record required

Full time documented business to business sales experience dependent on level as listed below. Pharmaceutical sales experience preferred. Level of the role will be commensurate to years of experience and performance criteria.

• Sales Specialist : Minimum 1 year
• Executive Sales Specialist : Minimum 7 years

TRAVEL REQUIREMENTS

Regular travel, which may include air travel and weekend or overnight travel

The annual starting salary for this position is between $88,000 – $170,000 annually. Factors which may affect starting salary within this range and level of role may include geography/market, skills, education, experience and other qualifications of the successful candidate.

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.
• Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

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.

• Managing all Labor Costing related accounting activities including Planning process and their reporting and reconciliations.
• Plays key role in the initial transition of processes in cost of labour planning activities into the Global Business Services. Therefore, tight communication and collaboration with local, regional and global accounting, FP&A, HR teams where needed.
• Standardize and streamline cost of labour planning process with clear methodology across all sites and BU’s;support local planners with queries and training on the proper usage of the CoL SAC planning platform.Build robust monthly recon process, run sanity checks on system output vs historical data etc.
• Understand and ensure adherence with applicable financial policies and guidelines with special emphasis on:CoL planning guidelines, global accounting policies, corporate FP&A and HR policies and AOP guidelines.
• Be fully accountable for all the CoL planning activities- plan, report, monitor and analyze.
• Perform regular scrutiny of ledgers, to ensure accuracy of general ledgers, cost center & profit center accounting.
• Support business decisions by providing ad hoc analytics and assessments for differentscenarios.
• Maintain analytical processes, routines and tools to support CoL analysis and validation.

SKILLS/QUALIFICATIONS:

• 5 to 7 years of relevant experience with finance background with strong working knowledge in financial planning, costing and cost of labor accounting.
• BCom/ M.Com / BBA/BBM /MBA Finance
• Strong analytical skills with the ability to collect, organize and analyze significant amounts of information with attention to detail and accuracy
• Workig experience in SAP Sucess Factors & SAP Analtyics on Cloud (SAC) prepered
• Excellent Excel capabilities
• Previous Work Force planning / Cost of Labour experience - advantage
• Fluent verbal and written communication in English
• Excellent collaboration with colleagues in the organization
• Ability to work effectively under pressure
• Location is based in Bangalore with Work from Office Culture
• Ability to travel within & outside India when required

Flexibility to work in shifts

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.

• Manage and process Accounts payable transactions. Invoices processed in timely manner
• Manage the payment proposal creation and payment disbursement of scheduled payments timely
• Manage urgent payment requests on a timely basis
• Adhere to Internal controls prerequisite and ensure all approvals/ supporting are suitably documented
• Ensure compliance with company policies and procedures
• Create Payment batch for H2H payments processing.
• Collaborate with Treasury on payment cash flow forecasts required and to resolve payment issues
• Contribute to process improvements to improve process efficiency and drive automation
• Manage failed payments/ rejections
• Respond to Generic mailbox inquiries within the agreed Turnaround Time
• Positively and creatively influence change and champion mission critical change initiatives
• Participating in internal control testing and prepares documentation
• Prepare ad-hoc & operational reports, manage analytics & management reporting
• Support Accounts payable and periodic book close activities on time as per the close calendar
• Prepare an effective SOP to outline the procedure & scope in the prescribed template. Perform periodically review and sign off

• Bachelor’s/ Master’s degree in Accounting
• 0-1 years of working experience in Accounts payable Invoice processing and payment disbursements
• Excellent written and verbal communication
• SAP Enterprise knowledge with FICO and MM modules
• High level of attention to detail
• Good working experience in SAP workflow, Read soft and Vendor portal
• Advanced Microsoft Excel skills, proficiency in MS office (PPT, VBA preferred)
• Good interpersonal skills to establish and maintain effective working relationships with a diverse population; ability to interact professional and courteously.
• Detail-oriented with the ability to manage multiple tasks simultaneously
• Flexible and adaptable to change, with the ability to work under pressure to meet deadlines in a fast-paced office environment .

Accountant II

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.