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Lead Analyst- Emerging Markets Strategy: Elevate Your Impact Through Innovation and Learning Evalueserve is a global leader in delivering innovative and sustainable solutions to a diverse range of clients, including over 30% of Fortune 500 companies. With a presence in more than 45 countries across five continents, we excel in leveraging state-of-the-art technology, artificial intelligence, and unparalleled subject matter expertise to elevate our clients' business impact and strategic decision-making. Our team of over 4, 500 talented professionals operates in countries such as India, China, Chile, Romania, the US, and Canada. Our global network also extends to emerging markets like Colombia, the Middle East, and the rest of Asia-Pacific. Recognized by Great Place to Work in India, Chile, Romania, the US, and the UK in 2022, we offer a dynamic, growth-oriented, and meritocracy-based culture that prioritizes continuous learning and skill development, work-life balance, and equal opportunity for all. Curious to know what its like to work at Evalueserve? Read on. About Investment Research (IR) As a global leader in knowledge processes, research, and analytics, youll be working with a team that specializes in global market research, working with the top-rated investment research organizations, bulge bracket investment banks, and leading asset managers. We cater to 8 of the top 10 global banks, working alongside their product and sector teams, supporting them on deal origination, execution, valuation, and transaction advisory-related projects. What you will be doing at Evalueserve Work directlywith the head of the team, who has been consistently ranked as the top analystin CEEMEA strategy by several top-tier investment banks. Handle research, strategy, and analytics for all EM fixed income-related products offered by theresearch platform of the banking client. Conduct macroeconomicand market research across emerging markets. Develop andmaintain financial models and analytical frameworks for EM fixed incomeproducts. Analyze largedatasets to identify market trends and investment opportunities. Support theteam in producing high-quality research reports and market commentary. Collaboratewith trading, sales, and risk teams to align strategy insights with businessneeds. Utilize toolssuch as Bloomberg, Macrobond, and Haver, and IMF databases for data extractionand analysis. What were looking for: Advanceddegree in economics /statistics /engineering with minimum relevant experienceof 3 years. Progress towards CFA / FRM is preferable. Priorexperience of macro research, financial modeling, structuring, trading, ormarket risk management Keen interestin global financial markets and knowledge of recent developments. Strongquantitative and mathematical skills with experience of working with largeamounts of data. AdvancedExcel, VBA analytical skills, and knowledge of basic econometrics is a must.Working knowledge of Python or R will be considered a plus. Excellentwritten and verbal communication skills ability to write research reports andcomment on market developments. Knowledge ofdatabase tools Bloomberg, Macrobond, Haver, World Bank, IMF, etc. Follow us on https://www.linkedin.com/compan y/evalueserve/ Click here to learn more about what our Leaders talking on achievements AI-powered supply chain optimization solution built on Google Cloud. How Evalueserve is now Leveraging NVIDIA NIM to enhance our AI and digital transformation solutions and to accelerate AI Capabilities . Know more about how Evalueserve has climbed 16 places on the 50 Best Firms for Data Scientists in 2024! Want to learn more about our culture and what its like to work with us? Write to us at: careers@evalueserve.com Disclaimer: The following job description serves as an informative reference for the tasks you may be required to perform. However, it does not constitute an integral component of your employment agreement and is subject to periodic modifications to align with evolving circumstances. Please Note: We appreciate the accuracy and authenticity of the information you provide, as it plays a key role in your candidacy. As part of the Background Verification Process, we verify your employment, education, and personal details. Please ensure all information is factual and submitted on time. For any assistance, your TA SPOC is available to support you.

Compile, prepare, review and submit ANDA submissions and Amendments to FDA with an overall objective to avoid major deficiencies and contribute to get approval within the shortest timeframes possible. Maintains full awareness of all regulatory activities on assigned projects and ensures that project deadlines and performance standards for these projects are established and met. Must have expertise/prior experience in Sterile (Injectables/Ophthalmic/Otic/IV Bags) dosage form ANDAs either with Aseptic sterilization or Terminal sterilization or both techniques. Ensure timely submission of all assigned projects. Review / prepare documents which meet the requirement set forth by US FDA and accepted for review by FDA without query or RTR. Evaluate change controls and formulates strategies for correct filing categories, with minimal involvement of supervisor. Proactively raises major issues if any to superior for resolution and agreement. Compile and submits critical post-approval supplements, such as CBE, CBE-30 and PAS. Work very closely with all relevant departments at the time of product initiations, R&D phase, ANDA/Bio Execution and after initiation of stability to ensure timely availability of all documents to ensure timely submissions. Prepare and finalize controlled correspondence as well as Pre-submission meeting package (Pre-ANDA, Pre-IND and Pre-NDA) to FDA on specific issues as needed for assigned projects. Assess the deficiency letter immediately after receipt from FDA, perform in-detail gap assessment and discuss with superiors to finalize the strategy to respond the deficiency. Proactively raises major project issues to superior for resolution and agreement. Be flexible in timings and available for t-cons as per US team schedule. Evaluate final compositions for IIG and Proportionality similar criteria s and develop regulatory strategies to avoid acceptable for filing issues. Review the API DMFs thoroughly and share the review comments to purchase department on-time. Follow up with purchase team or with DMF holder directly as needed to ensure compliance to provided comments on-time. Responsibilities: Ability to maintain a high level of accuracy and attention to detail, while meeting deadlines for assigned projects. Excellent written (Technical writing) and verbal communication skills and interpersonal skills. Prior experience working with ANDAs, INDs, NDAs and FDA correspondences. Time management, organization and planning skills, multi-tasking and prioritization skills in a fast-paced environment are required. Ability to communicate effectively and collaboratively as part of a team in a respectful manner. Ability to interface with professionals domestically and abroad. Ability to work independently, self-starter. Working knowledge of ICH, FDA and 21 CFR regulations. Should archive and maintain all submissions in a systematic way. Performs administrative functions as directed by Management to support projects and to ensure the smooth operation of the department. Maintain current knowledge of regulations and other issues that affect products and industry. Good problem solving skills and analytical ability. Strong computer skills in order to learn new programs as quickly as possible. Experience in MS Word, Excel, Power-point, Outlook and Adobe Professional is a must. Skills: Required Skills: Regulatory Submission & Dossier Filing | Advanced Regulatory Guidelines Knowledge | Advanced Cross Functional Communication | Intermediate Change Management & Documentation | Intermediate Problem Solving & Risk Mitigation | Intermediate Change Control & Regulatory Impact Assessment | Advanced Product Lifecycle Management | Advanced CMC Documentation | Advanced Health Authority Query Response | Advanced Regulatory Strategy Development | Advanced

Message to applicants applying to work in the U.S. and/or Canada: When available, the salary range posted for this position reflects the projected hiring range for new hire, full-time salaries in U.S. and/or Canada locations, not including equity or benefits. For non-sales roles the hiring ranges reflect base salary only; employees are also eligible to receive annual bonuses. Hiring ranges for sales positions include base and incentive compensation target. Individual pay is determined by the candidates hiring location and additional factors, including but not limited to skillset, experience, and relevant education, certifications, or training. Applicants may not be eligible for the full salary range based on their U.S. or Canada hiring location. The recruiter can share more details about compensation for the role in your location during the hiring process. U.S. employees have access to quality medical, dental and vision insurance, a 401(k) plan with a Cisco matching contribution, short and long-term disability coverage, basic life insurance and numerous wellbeing offerings. Employees receive up to twelve paid holidays per calendar year, which includes one floating holiday (for non-exempt employees), plus a day off for their birthday. Non-Exempt new hires accrue up to 16 days of vacation time off each year, at a rate of 4.92 hours per pay period. Exempt new hires participate in Cisco s flexible Vacation Time Off policy, which does not place a defined limit on how much vacation time eligible employees may use, but is subject to availability and some business limitations. All new hires are eligible for Sick Time Off subject to Cisco s Sick Time Off Policy and will have eighty (80) hours of sick time off provided on their hire date and on January 1st of each year thereafter. Up to 80 hours of unused sick time will be carried forward from one calendar year to the next such that the maximum number of sick time hours an employee may have available is 160 hours. Employees in Illinois have a unique time off program designed specifically with local requirements in mind. All employees also have access to paid time away to deal with critical or emergency issues. We offer additional paid time to volunteer and give back to the community. Employees on sales plans earn performance-based incentive pay on top of their base salary, which is split between quota and non-quota components. For quota-based incentive pay, Cisco typically pays as follows: .75% of incentive target for each 1% of revenue attainment up to 50% of quota; 1.5% of incentive target for each 1% of attainment between 50% and 75%; 1% of incentive target for each 1% of attainment between 75% and 100%; and once performance exceeds 100% attainment, incentive rates are at or above 1% for each 1% of attainment with no cap on incentive compensation. For non-quota-based sales performance elements such as strategic sales objectives, Cisco may pay up to 125% of target. Cisco sales plans do not have a minimum threshold of performance for sales incentive compensation to be paid.

Role & responsibilities Review and authorize change controls, assessing their impact on regulatory submissions. * Coordinate and organize meetings with cross-functional teams to discuss IRs, DRLs, and CR letters from agencies; circulate Minutes of Meeting (MoM) and follow up on action items. * Compile and coordinate high-quality CMC regulatory submissions for the US market in compliance with current regulatory guidelines and timelines. * Assess change controls from formulation plants and categorize them based on risk to product quality and compliance. * Plan, review, and submit CBE, CBE-30, and Prior Approval Supplements (PAS). * Draft high-quality responses to regulatory agency letters (IR, DRL, CR) within stipulated timelines. * Evaluate and interpret post-approval changes including: * Alternate excipients * Alternate packing materials * Alternate API source additions * Site and pack additions * Review key regulatory documents such as specifications, process validation reports, hold time reports, stability protocols/data, Nitrosamine risk assessment reports, and technical packages. * Assist in developing standards and SOPs for operations and production procedures. * Stay updated with evolving global and regional regulations affecting submissions. * Provide daily activity updates to the Regulatory Affairs Manager. * Prepare monthly reports and provide timely updates to superiors. * Uphold the highest standards of professional integrity in all RA activities. * Actively participate in continuous improvement initiatives within the department. Preferred candidate profile * Master's degree in Pharmaceutics, Pharmaceutical Analysis, Regulatory Affairs. * Strong knowledge of US FDA regulatory guidelines and CMC documentation. * Excellent communication, coordination, and documentation skills. * Attention to detail and ability to manage multiple priorities effectively.

As the Manager of India OSD Pre-approval ANDA portfolio, Injectable Drug Substance pre-approval portfolio, and Global DMF Review portfolio, your primary responsibilities involve providing Drug substance/nitrosamine review support to complex projects, including 505(b)(2), Europe & Canada projects. You will also participate in cross-functional meetings to address regulatory/technical issues and facilitate decision-making processes. Additionally, it is essential to engage with API vendors to gather relevant information and prevent any deficiencies in Drug Substance. Your role also encompasses bridging DMF/API related regulatory decisions between Raks & Amneal Teams, conducting training sessions on regulatory topics, and ensuring the quality and compliance of critical documents/submissions related to DMFs, ANDAs/S, and Amendments. Furthermore, you will be responsible for formulating RA Strategy of ANDA/DMF/DS for ongoing projects, ensuring timely submissions to regulatory authorities, leading the Global DMF Team/Process, and coordinating global regulatory efforts for DMF/API between Raks, Amneal India & Amneal USA teams. Innovation and continuous improvement are key aspects of your responsibilities, as you will be developing RA tools, coordinating with SSSM team/vendors for document requirements, resolving DMF critical issues, and supporting audits with necessary regulatory information. Your role will also involve evaluating critical change notifications, supporting launch activities, handling team management and development, project distribution, resource planning, and candidate selection processes. Additionally, you will conduct yearly performance appraisals, approve team attendance, and ensure compliance with regulatory submissions. The ideal candidate for this role should have an M. Pharm / M. Sc. qualification and possess strong leadership skills, regulatory knowledge, and the ability to drive regulatory compliance across various projects and teams effectively.,

About The Role : Job TitleCorporate Trust - Debt & Agency, Analyst LocationMumbai, India Role Description OverviewBusiness Division Deutsche Banks Corporate Bank (CB) a market leader in cash management, trade finance & lending, securities services, and Trust & Agency Services. Focusing on the treasurers and finance departments of corporate and commercial clients and financial institutions across the globe, our universal expertise and global network allows us to offer truly integrated and effective solutions. Trust and Agency Service (TAS): With offices in New York, California, London, Frankfurt, Milan, Lisbon, Dublin, Hong Kong, Singapore and Tokyo, the Trust and Agency Services team at Deutsche Bank has long been recognized as a leader in the provision of administrative and fiduciary services to the global debt and equities markets. It supports structures from the simplest to the most complex, covering Asset Backed Securities, CLOs and Managed accounts, Corporate Debt, Escrows, Project Finance, Loan Agency and Depositary Receipts. Summary: The Corporate Trust business is responsible for a broad portfolio of conventional debt and securitization transactions and service teams are required to engage directly with transaction parties supporting the administration of structured and non-structured debt issuances in accordance with the contractual terms. This role is exciting and broad rangingthe successful candidate will have extensive interaction across the transaction value chain and will be a critical component of the end to end service delivery to the client on a day to day basis ensuring all requirements are met in an accurate and timely manner. Duties will include processing client transactions and instructions, maintaining internal systems, producing reports in support of the front office to ensure the client receives the best possible service at all times. The successful candidate will be required to cover European working hours supporting the EMEA business Corporate title will depend on the relative experience of candidate. What well offer you 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Accident and Term life Insurance Your key responsibilities Supporting the Corporate Trust EMEA business across a portfolio of products and services including Debt Capital Markets bonds and programme debt, liability management, project finance, asset repackaging vehicles and escrows Timely completion of client & deal management system records, for record keeping, document handling and revenue management - ensuring accuracy of data at all times Processing and settlement of deal related transactions - including account opening, payments, investments and securities settlements Interacting with deal parties including swap counterparties and investors as necessary Monitor and reconcile client ledgers, bank ledger, fee billing, late payment claims and other operational MIS break reports, providing regular feedback to client services management on all outstanding items Interact daily with operations teams to support all debt servicing requirements including query management and resolution Timely escalation of client or operational problems to team leaders / department head as relevant Supporting fellow team members, team leaders and department head on an ongoing basis Any other duties or ad-hoc projects as required Your skills and experience Relevant experience in a similar role in investment banking or corporate banking administration A good understanding of the global financial services industry, Fixed income and Debt Capital Markets Familiarity with debt capital markets transaction documentation is advantageous, but not essential A practical knowledge of banking operations and an understanding of SWIFT / payment processing Basic accounting knowledge and / or strong reconciliation skills Experience at interacting widely through a financial services organization The ability to work under pressure, handle multiple priorities and work as part of a team as well as individually Fluent written and spoken English is essential Additional European language skills including German, Spanish, Italian, French and Russian would be beneficial but not essential You will be: An effective and concise communicator, both verbal and written Numerate and analytical with strong attention to detail Able to interact with people from different business/disciplines acting consistently throughout the organization. A team player with strong communication skills, a proactive mind-set and a professional attitude to delivery and client-focus Able to work in a challenging and rapidly changing business environment Able to adapt to complex financial and operational matters PC literate with good working knowledge of Microsoft Office products particularly MS Excel. Parts of the role will be using internal systems for which training will be provided Educated to degree level or similar How well support you

Job Purpose and Impact The Business Analyst - HR Core will lead efforts through influence that will enable change in an organizational context through the creation of the definition of the business needs and the creation of solution recommendations that deliver value to stakeholders. In this role, you will use advanced knowledge of the tasks and techniques that are used to perform complex business analysis such as solution evaluation, strategy analysis, elicitation and collaboration, requirement life cycle management, requirements analysis and design definitions and business analysis planning and monitoring to advance the profitability or efficiency of the business. You will partner effectively with all levels of the organization, guide others, drive results, proactively identify and resolve problems and make challenging decisions to improve business performance. Key Accountabilities Facilitate requirements gathering sessions with business stakeholders, document requirements and create initiatives that support the business requirements and needs. Identify and effectively articulate the need for change in how the organization works and facilitate change applying change management methodologies. Identify and define the solutions to complex business problems that will maximize the value delivered to stakeholders. Guide the business through unknown or unmapped territory to advance to the desired destination as the liaison to cross functional, regional and global solutions delivery teams. Use a thorough comprehension of complex internal or external business issues to analyze the organization or business domain and document business, data, processes or systems and provide an assessment of the business model and the integration with technology. Create test scripts using a traceability matrix tied back to requirements and assist in management of user acceptance testing cycles. Collaborate across all levels of the organization to collect information about an organizations operations to improve systems and processes, research business processes, analyze the potential impact and create and effectively communicate recommendations for the leadership team. Independently handle complex issues with minimal supervision, while escalating only the most complex issues to appropriate staff. Partner to evolve the capability associated with the process and technology, identify opportunities to optimize processes for improved user experience and conduct regular reviews of standards and success measures. Qualifications MINIMUM QUALIFICATIONS: Bachelors degree in a related field or equivalent experience. Minimum of four years of related work experience. Other minimum qualifications may apply. PREFERRED QUALIFICATIONS: 3+ years experience in SuccessFactors Employee Central (any other modules a plus). Experience in Human Resources with core processes. Certified Six Sigma (green / yellow belt) and / or Kaizen. Identify and define solutions to moderately complex business problems that will maximize the value delivered to stakeholders. Support implementation of the operating model of a domain process by collaborating closely with human resources leaders to drive continuous improvement across the assigned domain. Support implementation of programs to build process and technology capability, identify opportunities to optimize processes for improved user experience and participate in regular reviews of standards and success measures.

Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Contract Management Good to have skills : NAMinimum 3 year(s) of experience is required Educational Qualification : 15 years full time education Summary :Contract Lifecycle Management (CLM) Subject Matter Expert (SME) is someone with deep knowledge and experience in using CobbleStone's Contract Insight software to manage the entire contract lifecycle. This includes tasks like contract requests, authoring, negotiation, approval, execution, management, and renewal. They understand the system's features, configurations, and integrations, and can guide others in leveraging it effectively. Must have skills:3+ years of Cobblestone or similar Conract life cycle management tool hands on experience High analytical skills to understand and implement the requirementsGood communication and ability to handle client and cross team communications independently and effectively Ability to create meaningful requirement and status documentation in client specific formatFunctional testing knowledge Good to have:Certification in cobblestone or IcertisHealthcare Domain knowledge Qualification 15 years full time education

Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : Contract Management Good to have skills : NAMinimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :Contract Lifecycle Management (CLM) Subject Matter Expert (SME) is someone with deep knowledge and experience in using CobbleStone's Contract Insight software to manage the entire contract lifecycle. This includes tasks like contract requests, authoring, negotiation, approval, execution, management, and renewal. They understand the system's features, configurations, and integrations, and can guide others in leveraging it effectively. Must have skills:3+ years of Cobblestone or similar Conract life cycle management tool hands on experience High analytical skills to understand and implement the requirementsGood communication and ability to handle client and cross team communications independently and effectively Ability to create meaningful requirement and status documentation in client specific formatFunctional testing knowledge Good to have:Certification in cobblestone or IcertisHealthcare Domain knowledge Qualification 15 years full time education

We are looking for a young and talented individual to market our specialized products within the travel agents network in Maharashtra & Gujarat People with prior experience within the travel industry , specifically looking into channel sales will be preferred The job will require traveling within Mumbai & the states of Maharashtra & Gujarat Our Major Products will include Ladakh tours for the Summer along with Europe & Sri Lanka tour products

Incoda Media is looking for Assistance Manager / Manager - Media Sales to join our dynamic team and embark on a rewarding career journey Achieve growth and hit sales targets by successfully managing the sales team Design and implement a strategic business plan that expands company€™s customer base and ensure it€™ s strong presence Own recruiting, objectives setting, coaching and performance monitoring of sales representatives Build and promote strong, long-lasting customer relationships by partnering with them and understanding their needs Present sales, revenue and expenses reports and realistic forecasts to the management team Identify emerging markets and market shifts while being fully aware of new products and competition status

Key Responsibilities 1. Executive Support Manage and prioritize the executives calendar, ensuring optimal use of time across time zones Schedule internal and external meetings, organize travel logistics, and coordinate accommodations Handle email, phone, and other communications with discretion and professionalism Prepare executive-level presentations, reports, and documentation for business reviews and leadership meetings Manage expense reports and provide end-to-end administrative support 2. Special / Strategic Project Support Assist in driving special projects, ensuring timelines and deliverables are metTrack project milestones, identify bottlenecks, and coordinate with stakeholders for timely updates Consolidate data from multiple teams for reports, dashboards, and presentations Contribute to executive decision-making through data-backed inputs 3. Engagement & Collaboration Organize internal events such as town halls, leadership offsites, and business reviews (QBRs, MBRs) Manage scheduling and logistics for all-hands calls and other leadership communications Coordinate closely with cross-functional teams across geographies Liaise with Regional HR to support and implement employee engagement initiatives 4. Operational & Business Coordination Address business escalations and service requests in coordination with respective departments Manage meeting documentation capturing minutes, action items, and ensuring timely follow-ups Act as a bridge between the executive office and key internal/external stakeholders Essential Qualifications & Skills Education MBA or equivalent qualification from a reputed institution (preferred) Core Competencies Excellent organizational and multitasking abilities Strong verbal and written communication skills Proficiency in MS Office tools Outlook, Word, PowerPoint, and Advanced Excel High degree of ownership, integrity, and professionalism Ability to work autonomously and with cross-functional teams Analytical mindset with attention to detail Adaptability to work across time zones and under tight deadlines Experience 57 years in an Executive Assistant or equivalent role, preferably supporting C-suite or senior leadership Experience working in a fast-paced corporate environment Prior exposure to the telecommunications, IT, or technology sector is a plus Comfortable with global collaboration and time zone flexibility Additional Skills (Desirable) Experience with business operations, stakeholder engagement, or internal communications Event planning and execution capabilities Contribute to strategic planning and business rhythm alignment

IP evaluation of Formulation & Drug-Device combination products. Claim chart preparation, Structuring FLBs & supporting Litigation. IP creation via Patent filing for our 505(b)2 range of products. Provide IP support to Central Portfolio Team for USA & International Market. IP Support & Due diligence involving new business opportunities. IP creation via Patent filing for our 505(b)2 range of products. Track pending patent applications/OB listings/Competitors ANDA & litigation strategy, assessing the impact on our pipeline - keep Sr. Management informed.

: Prepare and review Peptide API Drug Master Files (DMFs) for submission to the US FDA and other regulatory agencies. Handle deficiency responses and interact with regulatory authorities for query resolution and clarification. Prepare and manage ANDA Drug Substance Modules and support associated submissions and updates. Compile and submit DMFs, and support any lifecycle management or post-submission queries. Maintain current knowledge of regulatory guidelines and ensure regulatory compliance across all submissions. Participate in internal and external project discussions and contribute to the preparation of regulatory project presentation slides and documentation. Ensure coordination between R&D, Quality, and Manufacturing teams for gathering and verifying technical data. Exhibit strong technical writing and communication skills to ensure clarity and compliance in submissions. Support regulatory strategy development and planning for new drug substance filings. Required Skills: Peptide API DMF Preparation | Expert DMF Review & Deficiency Responses | Expert Regulatory Knowledge | Expert Technical Writing | Expert Communication & Coordination | Expert

Educational Requirements Bachelor of Engineering Service Line Infosys Quality Engineering Responsibilities Global Pay Plus Testers. MT MX messaging , SWIFT payments Preferred Skills: Banking-GPP Financial Services Domain-Payments-GPP Generic Skills: Banking

Role & responsibilities 1. Characterization of RLD pack samples. 2. Finalization of packing configuration for Exhibit batch packing of new generic product/NDA as per requirement. 3. Identification of new packaging material & new vendor development for packaging materials. 4. Mold development for primary packaging material & secondary packaging material & its validation. 5. Support to Regulatory team on ANDAs/NDA’s filling for regulated market. 6. Coordination with NPI & planning team for launch of ANDA’s/NDA’s. 7.Preparation & revision of packaging material specification. 8. Preparation & review of MPC, FMEA, TA, DHF & AFMEA. 9. Preparation & review of Development Study protocol & report & execute the study. 10. Performing functional test as per regulatory requirement. 11. Coordination with Cross functional team like (FDD/RA/Plant/Marketing/PMO) for completion of task. 12. Participating in FAT of machines. 13. Support to plant for validation, trouble shooting and market complaints. 14. SOP preparation, periodic review and packaging lab equipment handling/maintain calibration records. 15. Preparation of Packaging documentation (Pack Style, Justification Report etc. as per Product/Regulatory) as required. 16.Handling of primary and secondary packaging material in storage area & maintaining the PM quantity for stability packaging at R&D.

Role & responsibilities Handling of pre and post approval regulatory activities of US/EU/CA submissions. Review of developmental documents for regulatory submission. Good knowledge of handling CMC documentation for Dossier submission Compilation and Submission of Annual reports and Supplements. Having the experience of solid orals and injectables. Preparation of Sterility Assurance Package for injectable Dossiers. Preparation of Pre-IND/scientific advice meeting packages Drafting, compiling & eCTD publishing of dossiers for regulatory filings. Review of specifications and test procedure as per pharmacopoeia requirements. Providing regulatory support for customer filings and customer queries. Evaluation of regulatory authority deficiencies and preparation of action plan accordingly. Also follow up of response documents with concern stake holders. Evaluation and approval of QMS documents, wherever applicable. To update cross functional teams for different regulatory compliance & requirements. Responsible for outlining requirements for labelling, storage and packaging. Review of product development report and QBD concepts. Updating product approval package to plant team. Preferred candidate profile Should Have Formulation Regulatory Affairs Relevant Experience in US/EU/Canada Perks and benefits

Message to applicants applying to work in the U.S. and/or Canada: When available, the salary range posted for this position reflects the projected hiring range for new hire, full-time salaries in U.S. and/or Canada locations, not including equity or benefits. For non-sales roles the hiring ranges reflect base salary only; employees are also eligible to receive annual bonuses. Hiring ranges for sales positions include base and incentive compensation target. Individual pay is determined by the candidates hiring location and additional factors, including but not limited to skillset, experience, and relevant education, certifications, or training. Applicants may not be eligible for the full salary range based on their U.S. or Canada hiring location. The recruiter can share more details about compensation for the role in your location during the hiring process. U.S. employees have access to quality medical, dental and vision insurance, a 401(k) plan with a Cisco matching contribution, short and long-term disability coverage, basic life insurance and numerous wellbeing offerings. Employees receive up to twelve paid holidays per calendar year, which includes one floating holiday (for non-exempt employees), plus a day off for their birthday. Non-Exempt new hires accrue up to 16 days of vacation time off each year, at a rate of 4.92 hours per pay period. Exempt new hires participate in Cisco s flexible Vacation Time Off policy, which does not place a defined limit on how much vacation time eligible employees may use, but is subject to availability and some business limitations. All new hires are eligible for Sick Time Off subject to Cisco s Sick Time Off Policy and will have eighty (80) hours of sick time off provided on their hire date and on January 1st of each year thereafter. Up to 80 hours of unused sick time will be carried forward from one calendar year to the next such that the maximum number of sick time hours an employee may have available is 160 hours. Employees in Illinois have a unique time off program designed specifically with local requirements in mind. All employees also have access to paid time away to deal with critical or emergency issues. We offer additional paid time to volunteer and give back to the community. Employees on sales plans earn performance-based incentive pay on top of their base salary, which is split between quota and non-quota components. For quota-based incentive pay, Cisco typically pays as follows: .75% of incentive target for each 1% of revenue attainment up to 50% of quota; 1.5% of incentive target for each 1% of attainment between 50% and 75%; 1% of incentive target for each 1% of attainment between 75% and 100%; and once performance exceeds 100% attainment, incentive rates are at or above 1% for each 1% of attainment with no cap on incentive compensation. For non-quota-based sales performance elements such as strategic sales objectives, Cisco may pay up to 125% of target. Cisco sales plans do not have a minimum threshold of performance for sales incentive compensation to be paid.

About the Role: Grade Level (for internal use): 10 About the Role: EMEA Benefits Specialist The Team: The Global Benefits Team is a team of specialists that focuses on the Wellbeing and Benefits for our colleagues across the globe supporting 40+ countries. The Impact We invest in our success as a company by investing in our people. At S&P Global, we are committed to comprehensive, competitive benefits for our people. We provide benefits to support the health and financial needs of our people while helping make their working life experience more rewarding. This is a critical role that touches each of our colleagues and is critical to our People First Philosophy. This role supports the wellbeing needs of our people while helping make their working life experience more rewarding. Whats in it for you To grow with a global company and learn more about key global benefits initiatives around the world. S&P Global puts our people first, and you will have the opportunity to participate in making positive change through global programs such as Wellbeing Reimbursement, Global Education, Global Parental Leave, Flexible Time Off program, Global EAP, Insured and Retirement benefits in the EMEA region. Responsibilities Manage benefits administration, renewals and day-to-day operations Support benefits programs involving the research and implementation of plans and programs as well as managing competitive benefits offered in the APAC region Subject matter expert for all benefits queries and escalations while also providing guidance and support to various business units Work closely with the external vendors, local leadership of the respective countries, HR partners, and other functions to offer best in class benefits and service to our employees Support APAC benefits projects and implementation related projects from beginning to end including benefits communication creation Develop and maintain policies and other documentation to educate all employees about the companys benefits programs. You'll be asked to work from office 2 days a week. What Were Looking For: Basic Required Qualifications: 4 years' minimum benefits experience Fluent English Exposure to managing benefits plans including benefits related regulatory and tax requirements Benefits project management skills. Capable of managing multiple tasks in an organized manner whilst interacting with various external and internal stakeholders Ability to engage and communicate effectively with employees and stakeholders while understanding their needs Microsoft Excel and PowerPoint experience. A self-starter that is motivated to achieve results whilst also being a team player Accurate, with great attention to detail A positive, flexible and proactive approach Additional Preferred Qualifications: German or French language will be beneficial Bachelor's degree desirable Workday knowledge is a plus If you meet the above qualifications and are passionate about designing and managing employee benefit programs, we would love to hear from you. Return to Work Have you taken time out for caring responsibilities and are now looking to return to workAs part of our Return to Work initiative, Restart, we are encouraging enthusiastic and talented returners to apply, and will actively support your return to the workplace. Whats In It For You Our Purpose: Progress is not a self-starter. It requires a catalyst to be set in motion. Information, imagination, people, technologythe right combination can unlock possibility and change the world.Our world is in transition and getting more complex by the day. We push past expected observations and seek out new levels of understanding so that we can help companies, governments and individuals make an impact on tomorrow. At S&P Global we transform data into Essential Intelligence, pinpointing risks and opening possibilities. We Accelerate Progress. Our People: Our Values: Integrity, Discovery, Partnership At S&P Global, we focus on Powering Global Markets. Throughout our history, the world's leading organizations have relied on us for the Essential Intelligence they need to make confident decisions about the road ahead. We start with a foundation of integrity in all we do, bring a spirit of discovery to our work, and collaborate in close partnership with each other and our customers to achieve shared goals. Benefits: We take care of you, so you cantake care of business. We care about our people. Thats why we provide everything youand your careerneed to thrive at S&P Global. Health & WellnessHealth care coverage designed for the mind and body. Continuous LearningAccess a wealth of resources to grow your career and learn valuable new skills. Invest in Your FutureSecure your financial future through competitive pay, retirement planning, a continuing education program with a company-matched student loan contribution, and financial wellness programs. Family Friendly PerksIts not just about you. S&P Global has perks for your partners and little ones, too, with some best-in class benefits for families. Beyond the BasicsFrom retail discounts to referral incentive awardssmall perks can make a big difference. For more information on benefits by country visithttps://spgbenefits.com/benefit-summaries Global Hiring and Opportunity at S&P Global: At S&P Global, we are committed to fostering a connected andengaged workplace where all individuals have access to opportunities based on their skills, experience, and contributions. Our hiring practices emphasize fairness, transparency, and merit, ensuring that we attract and retain top talent. By valuing different perspectives and promoting a culture of respect and collaboration, we drive innovation and power global markets. Recruitment Fraud Alert If you receive an email from a spglobalind.com domain or any other regionally based domains, it is a scam and should be reported to reportfraud@spglobal.com. 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Roles and Responsibilities Prepare ANDA dossiers, CMC modules, and submission documents for US FDA approval. Post approval and life cycle management of approved ANDA & suppliment filling. Review and prepare labeling documents (labels, cartons, pack insert) according to US regulations. Develop expertise in various therapeutic areas such as Cardiology, Diabetology, Neurology, Ophthalmology etc. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Ensure timely submission of applications to USFDA while maintaining high-quality standards. Desired Candidate Profile 8-10 years of experience in Regulatory Affairs with a focus on US market. Bachelor's degree in Pharmacy (B.Pharma) or Master's degree in Pharmacy (M.Pharma). Strong understanding of dossier preparation guidelines for USFDA submissions. Excellent communication skills for effective collaboration with internal stakeholders.

Regulatory Affairs Associate II Job Details | Teva Pharmaceuticals Find a Career With Purpose at Teva Search by Postal Code Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Regulatory Affairs Associate II Navi Mumbai, India, 400706 Who we are The opportunity The RA Associate II is responsible for preparing and revising high-quality US Gx labeling documents submitted under an ANDA and/or 505(b)(2), as required. This role ensures compliance with federal regulations, guidance documents, and internal procedures while meeting deadlines aligned with company objectives. The candidate must demonstrate the ability to work with minimal supervision and possess a thorough understanding of US FDA labeling regulations and guidance documents, applying this knowledge effectively across all work output. Additionally, they will be responsible for creating compliant Structured Product Labeling (SPL) files, ensuring complete drug listing information, and adhering to compliance requirements for importation, bulk listings, and related processes. How you ll spend your day Develop US labeling documents to align with company goals and submission requirements for assigned ANDAs and/or 505(b)(2)s, if required, and ensure labeling meets all legal and regulatory requirements. This includes QC, proofing, editing, and formatting of documents, and coordinating the review and approval of final submission documents Develop US labeling documents needed for early development projects requiring a human factor or comparative analysis study and ensure established labeling meets all legal and regulatory requirements. This includes QC, proofing, editing, and formatting of documents, and coordinating the review and approval of final submission documents with all relevant departments Some experience in developing labeling content that requires carve-outs due to protected language associated with patents/exclusivities Establish and maintain SPL for assigned projects. Ensure product data elements align with the required drug listing regulations and established SPL is submitted through FDA s Electronic Submission Gateway Prepare and electronically compile full responses to the FDA via the appropriate filing mode. This includes, but is not limited to, the development of side-by-side comparisons, SPL, and other required submission materials, as necessary Perform quality reviews of labeling and submission documents by proofreading established files for content accuracy, either manually or by utilizing the electronic proofreading tool TVT Work closely with external departments, including CMC and the Device team, to align with internal product/device strategy and process Work closely with Regulatory Operations, as well as in Teva s publishing software, to ensure assigned projects are submitted on time following the eCTD requirements related to labeling Support products falling under Business Development deals, if required, from a labeling/artwork and drug listing perspective Attend assigned project meetings to ensure labeling timelines are met Maintain an accurate project tracker of all assigned projects with identified due date priorities and timelines of initial assignment, initiation, and completion of projects Maintain knowledge of US regulations, guidelines, and standard operating procedures applicable to US Gx labeling Work in a team environment with minimal supervision Perform all other job-related duties as required by management and dictated by process changes Your experience and qualifications Bachelors in pharmacy/masters in science & Life sciences - 4-5 Years in the Pharmaceutical Industry Masters in pharmacy - 3-4 Years in the Pharmaceutical Industry Proven experience in regulatory affairs within the pharmaceutical, biotechnology, or medical device industry Be able to multi-task in a fast-paced work environment Have exemplary oral and written communication skills Be organized with keen attention to detail Have the ability to work independently as well as in a team environment with minimal supervision Have knowledge of US FDA regulations and guidance related to US Gx labeling Have knowledge of US FDA regulations and guidance related to US drug listing Have knowledge of US FDA eCTD submission standards and experience in applying these requirements to routine labeling submissions to the FDA PC, Microsoft Office Suite with a proficiency in Microsoft Word and Microsoft Excel Adobe Acrobat Professional is a must Familiarity with TVT preferred Teva s Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Tevas global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

Creation/Revision/ Review of Specifications and Methods for Site Transfers and ANDAs Method Validation Protocol knowledge. Creation/Revision/ Review of Validation Repot for Drug substance, Excipients and Drug products. Initiate Change controls as necessary for: Method and specification revisions and stability Protocol Modules preparation for Drug substance and Drug product. Batch Analysis 32S/32P Reference Standards 32S/32P Characterization of Impurities 32S/32P Justification of Specification 32S/32P Facility Templates Stability Summary Reports for ACC, CRT & RT 5313 Reports (Dissolution Comparative test) QOS & Stability Overview - 32S/32P (If ANDA) To prepare vendor qualification report based on the performance of material at test. To prepare justification reports towards reduction of tests in Input material testing such as raw and packaging material; In-process testing; Finished product testing; Stability testing. Preparation/Review of SOPs Preparation of cleaning validation method protocol and report Required Skills Data Integrity (ALCOA+ principles) | Advanced Regulatory knowledge (USFDA, MHRA, ICH Q series) | Advanced Method Validation Documentation | Advanced Method Development Understanding | Advanced CTD / eCTD Module Preparation (Primarily Module 3.2.S & 3.2.P) | Advanced

Regulatory Affairs Associate III, Labeling, Labeling Job Details | Teva Pharmaceuticals Find a Career With Purpose at Teva Search by Postal Code Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Regulatory Affairs Associate III, Labeling, Labeling Who we are The opportunity The RA Associate III is responsible for preparing and/or reviewing high-quality US Gx labeling documents submitted under an ANDA and/or 505(b)(2), as required. This role ensures compliance with federal regulations, guidance documents, and internal procedures while meeting deadlines aligned with company objectives. The candidate must demonstrate the ability to work independently and possess a strong knowledge of US FDA labeling regulations and guidance documents, applying this knowledge effectively across all work output. Additionally, they will be responsible for creating compliant Structured Product Labeling (SPL) files, ensuring complete drug listing information, and adhering to compliance requirements for importation, bulk listings, and related processes. How you ll spend your day Develop US labeling documents to align with company goals and submission requirements for assigned ANDAs and/or 505(b)(2)s, if required, and for early development projects requiring a human factor or comparative analysis study to ensure labeling meets all legal and regulatory requirements. This includes QC, proofing, editing, and formatting of documents, and coordinating the review and approval of final submission documents documents with all relevant departments. Develop labeling content that requires carve-outs due to protected language associated with patents/exclusivities. Serve as a Subject Matter Expert (SME) in all facets of SPL/drug listing, including but not limited to finished product, bulk, and manufacturer under contract. The SME must be able to provide guidance to other team members related to established SPL documents (content and data elements) to ensure alignment with associated applications and applicable FDA regulations and guidance, as well as troubleshoot any validation errors received. Work closely with the SPL Vendor, as well as the FDA Drug Listing team, on any drug listing issues, ensuring a rapid resolution. Prepare and electronically compile full responses to the FDA via the appropriate filing mode. This includes but is not limited to the development of side-by-side comparisons, SPL, and other required submission materials, as necessary. Perform quality reviews of labeling and submission documents by proofreading established files for content accuracy, either manually or by utilizing the electronic proofreading tool TVT. Work closely with external departments, including the CMC and Device teams, to align with internal product/device strategy and processes. Work closely with Regulatory Operations, as well as in Teva s publishing software, to ensure assigned projects are submitted on time following the eCTD requirements related to labeling. Support products falling under Business Development deals, if required, from a labeling/artwork and drug listing perspective. Attend assigned project meetings to ensure labeling timelines are met. Maintain an accurate project tracker of all assigned projects with identified due date priorities and timelines of initial assignment, initiation, and completion of projects. Provide support to the Manager, as needed, in completing the year-end FDA Mandated Blanket No Change certification. This ensures all drug product listings remain active within the agencys National Drug Code (NDC) Directory, preventing potential issues such as disruptions in the market, Medicaid rebates, and other regulatory complications. Assist in the training of new labeling personnel. Maintain knowledge of US regulations, guidelines, and standard operating procedures applicable to US Gx labeling and drug listing. Work in a team environment. Perform all other job-related duties as required by management and dictated by process changes. Your experience and qualifications 7-9 years experience in the Pharmaceutical Industry. Min 6+ years of RA experience will be preferred in the respective Markets. Bachelors in Pharmacy/Master in Pharmacy/Master in science & Life sciences Be able to multi-task in a fast-paced work environment. Have exemplary oral and written communication skills. Be organized with a keen attention to detail. Manage projects from initiation to completion. Collaborate effectively with cross-functional teams and team members to achieve project goals. Possess in-depth knowledge of US FDA regulations and guidance documents related to US Gx labeling and drug listing. Possess in-depth knowledge of US FDA eCTD submission standards and demonstrate experience in applying these requirements to routine labeling submissions. Proficiency with PC and Microsoft Office Suite, including Microsoft Word and Microsoft Excel. Thorough knowledge of Structured Product Labeling software. Proficiency in Adobe Acrobat Professional is a must. Teva s Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Tevas global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

Job TitleSA LocationMumbai / Pune Skill- End to end KYC, Periodic Review, AML, and Due Diligence Shift Timings:APAC , EMEA , NAM Roles & Responsibilities This role will include the understanding and implementation of the KYC lifecycle. He/she would be responsible for opening, amending, reviewing and exiting clients according to established policies and procedures, and also review clients transactions to detect and report either proposed or completed unusual transactions. Key responsibilities include: Performing the due diligence on new Clients, requesting the KYC information, documentation, review and verification of received documentation and making an analytical risk assessment for new Clients Thoroughly and succinctly document the research and analysis related to the financial activity and related entities of Clients Escalate issues to client and internal managers to bring issues to their attention promptly Independently handle clients and client calls establish self as a valued partner Help knowledge management endeavor by sharing process knowledge and best practices within the teams Communicate effectively and efficiently with relevant internal and external parties to obtain KYC documents Have a thorough understanding of the clients business and related parties to monitor clients activities for unusual transactions Perform further investigation on identified suspicious client and clients transactions and report to KYC/AML compliance officer Qualification and Skills Bachelors Degree (B.Com, BBA, BBM, BCA) / Masters Degree (M.Com, MBA, PGDM). 2 to 4 years of experience and knowledge of KYC, AML, and Due Diligence Should be able to understand, manage and calculate risks Should be good with logical and quantitative abilities eClerx Financial Markets offers consulting, technological innovation, and process management expertise to uniquely solve operational challenges for financial organizations worldwide. With nearly two decades of industry experience, complemented by smart automation and robotics, our team of experts delivers holistic solutions across the trade lifecycle, change management, data analytics, compliance, cash securities operations, document digitization and generation, and outreach.

Develop tablet/capsule formulations for regulated markets (US/EU). Conduct pre-formulation, prototype trials, and scale-up. Execute lab, exhibit, and validation batches. Prepare technical documents for ANDA filings. Support tech transfer and respond to regulatory queries.