331 Usfda Jobs

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.

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.

Role & responsibilities Review of post approval changes and evaluating its impact on the products. Preparation of appropriate post approval submissions such as PAS, CBE 30 & 0, and annual reports. Management of product life cycle. Managing Team Dosage Form : Solid Oral / Nasal / Liquid/ Ophthalmics Preferred candidate profile 10+ Years of USFDA post approval submission experience USFDA Experience Exposure to ANDA /NDA post approval submissions Please share updated CV on hr19@hectorandstreak.com

Long Description The person should have knowledge in Manufacturing equipments. He should have exposure in equipment’s such as FBE,Fette/KORSCH M/C & auto coater M/C. He should be able to handle equipment trouble shoot in Manufacturing department. He should have exposure in regulatory organization . He must have faced the USFDA ,MHRA & other regulatory audits. He should have the exposure in Caliber QAMS, elog, track wise ,SAP ,WIND ,CDAS & other software. He should have the exposure in process simplification/optimization ,SABA ,elog & SCADA. Competencies Education Graduation in Pharmacy Work Experience 3-6 years of experience in Fette compression machine

Job Description We are hiring a Senior Regulatory Affairs Executive with around 5 years of experience in regulatory submissions for international markets, especially USFDA and EDQM . This role involves end-to-end regulatory dossier preparation and submission, technical data coordination, and maintaining compliance with global regulatory standards in an API manufacturing environment. Key Responsibilities Prepare, compile, and submit regulatory dossiers (DMFs, CEPs, ASMFs) to international authorities, focusing on EDQM and USFDA. Coordinate cross-functionally with R&D, QA, QC, and Production teams for document and data collection. Maintain submission timelines and follow-up systems for timely responses and approvals. Provide regulatory intelligence, evaluate changing guidelines, and ensure compliance for ongoing projects. Handle deficiency responses and audits with strong documentation and archiving practices. Act as a regulatory liaison with internal and external stakeholders. Job Location : Innov8 Suman Business Park Kalyani Nagar Pune Apply to: recruitment@dnplfactory.com Contact No: 8956760759

Roles and Responsibilities Prepare dossiers for regulatory submissions, including CTD/eCTD format. Ensure compliance with USFDA regulations through dossier compilation and submission. Manage RA activities from pre-clinical to post-marketing stages, covering both domestic and international markets. Develop expertise in drug regulatory affairs, focusing on row market requirements. Collaborate with cross-functional teams to ensure timely completion of projects.

Purchase Manager / Sr. Manager (Pharmaceutical API Manufacturing) Posted: July 2025 Drive end to end strategic procurement for a multi regulator approved API manufacturer own raw materials, solvents, intermediates, packaging, capex, and vendor development while ensuring cGMP/ICH Q7 aligned supplier qualification, compliant documentation, and inventory control that supports global regulatory readiness (US FDA / EU GMP / Indian approvals)

Urgent opening for Head QA with rich experience in MHRA site. Job location Chandigarh

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

You will be responsible for reviewing R&D developmental data of ARD and PD including Method Development Reports, Method Validation Reports, Characterization Reports, Product Development Report, and Study Reports to ensure accuracy, data integrity, and compliance with systems, procedures, and regulatory requirements. Additionally, you will review Technology Transfer documents such as Method Transfer protocol/Reports, Master Formula Records, Master Packaging Record, Stability Study protocol, Specifications, and MOAs. Conducting routine laboratory rounds to ensure compliance with Good Laboratory Practices will be part of your responsibilities. You will also handle Change Controls, Deviations, Incidents, and Laboratory Assessment Reports. Preparing and reviewing SOPs, conducting SOP training, and providing training on Good Laboratory Practices to R&D personnel are also key tasks. Management of development stability samples, including protocol review, sample charging, stability calendar updation, and sample withdrawal, will fall under your purview. Other duties include handling the receipt, issuance, and management of RLDs and Exhibit batch samples, as well as issuing R&D documents like LNBs, Forms, and Logbooks for routine use. You will be responsible for maintaining the Document Archival room of R&D, issuing archived documents upon request, and managing the receipt, storage, issuance, and management of Working Standards, Reference Standards, Impurity standards, and Chromatographic columns. Additionally, you will review and approve Instrument/Equipment Qualification and calibration records. Your skills should include expertise in Quality Management systems, Good Laboratory Practices, Analytical Method Development & Validation review, Documentation Control, and Stability Studies. Intermediate proficiency is required in Product Development Report Review, Internal Quality Audits, and Review of Specification and MoAs. In addition, you should have a basic understanding of Training and advanced knowledge of USFDA, ICH, EMA Guidelines, and USP General Chapters. Qualifications: - M. Pharm. - M. Sc. (Chemistry/Biochemistry) Amneal is an equal opportunity employer that values diversity and inclusion. The Human Resources team, with its various roles including Executive, Audit, Facilitator, Consultancy, and Service, partners with all aspects of the organization to drive success through effective people management.,

US (FDA) Regulatory Support: Prepare and submit: 510(k) premarket notifications,PMA,supplements or De Novo requests (if applicable),Support establishment registration Medical device listing, Ensure compliance with 21 CFR Part 820 (QSR) and UDI Office cab/shuttle Annual bonus Health insurance Provident fund

: 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

Skill required: Regulatory Services - Life Sciences Regulatory Operations Designation: LifeScience Regulatory Svs Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The incumbent will perform the regulatory operations tasks of bookmarking and hyper linking for granular components (documents) of submission in accordance with ICH guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components.Coordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for sBachelor Degree in Life Sciences Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Skill required: KYC Screening - Sanctions Screening Designation: Regulatory Compliance Analyst Qualifications: BCom Years of Experience: 3 to 5 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Help clients transform their compliance function from reactive to proactive through an intelligent compliance operating model powered by data, intelligent technologies and talentLooking for someone with KYC experience along with ECDD/OCDD knowledgeAbility to effectively and efficiently conduct the process of screening individuals, entities, or transactions against lists of sanctioned or restricted parties. Sanctions screening involves using specialized software, understanding relevant regulations, and maintaining a proactive approach to mitigate the risk of engaging with sanctioned entities. What are we looking for Commitment to qualityCollaboration and interpersonal skillsAbility to work well in a teamAbility to perform under pressureAbility to meet deadlines Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualification BCom

The candidate will be responsible for the proper receipt, storage, and GMP-compliant dispensing of raw materials used in pharmaceutical production Perform raw material dispensing activity in designated dispensing booths under controlled conditions.. Required Candidate profile Receive, inspect & label incoming raw materials as per SOP Coordinate with the QA, Production & QC department during material movement Ensure adherence to GMP, GDP & safety guideline during dispensing

Role & responsibilities Manage technology transfer activities from development to commercial manufacturing for OSD tablets. Oversee and execute process scale-up, process optimization, and validation to ensure smooth transition into commercial production. Maintain an in-depth knowledge of USFDA regulations for OSD products and ensure compliance with all regulatory requirements during tech transfer activities. Work closely with R&D, manufacturing, and quality teams to address any technical challenges during tech transfer. Preferred candidate profile Prefered candidates from OSD (manufacture Tablets , capsules,)background . USFDA experince is must Its a plant based role.

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. S&P Global never requires any candidate to pay money for job applications, interviews, offer letters, pre-employment training or for equipment/delivery of equipment. Stay informed and protect yourself from recruitment fraud by reviewing our guidelines, fraudulent domains, and how to report suspicious activity here. ---- Equal Opportunity Employer S&P Global is an equal opportunity employer and all qualified candidates will receive consideration for employment without regard to race/ethnicity, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, marital status, military veteran status, unemployment status, or any other status protected by law. Only electronic job submissions will be considered for employment. If you need an accommodation during the application process due to a disability, please send an email to EEO.Compliance@spglobal.com and your request will be forwarded to the appropriate person. US Candidates Only The EEO is the Law Poster http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf describes discrimination protections under federal law. Pay Transparency Nondiscrimination Provision - https://www.dol.gov/sites/dolgov/files/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf ---- HUMRES202.1 - Middle Professional Tier I (EEO Job Group)

Role & responsibilities: To enhance the quality system by imparting cGMP knowledge and updating regulatory requirements to the sites. To provide new regulatory guidance and technical documents to the site. To maintain a quality intelligence database and inform the concerned site about current regulatory requirements, updates and changes as and when required. To prepare corporate quality policy, standard practices, and corporate directives for system harmonization across all sites. To evaluate and ensure continual improvement of the quality management system. To verify policy implementation at the site and extend the identified gaps to the site for compliance. To review and evaluate regulatory guidelines, other company 483s, warning letters and inspection reports as per current regulatory requirements and extend identified gaps into quality intelligence portal to sites for compliance. To inform the Zydus family about new quality issues, current regulatory inspection trends, forecasts and best possible practices. To impart policy training to the site as and when required. To initiate corporate change controls for preparation and revision of quality policies. To review, verify and monitor the implementation of extended Global CAPA, Policy implementation observations and quality intelligence observations at sites. To perform any other activity assigned by HOD, as and when required. Preferred candidate profile: 2 Vacancies: one is for QA OSD background and second is for QA Injectable background. Candidate must be from pharma QA (OSD or Injectable) background. Must have Good communication skill, drafting skill and interpersonal skills. Must ready to travel to site location for inspections and audit. Must be ready to work at Ahmedabad location.

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.

Function:PMSRole:Post Market SurveillanceDesired Skills:PMS, complaint handlingCreate PMS plan, PMS report, PSUR report as per EUMDR, Trend report & Complaint analysis Risk management Risk assessment. Required Candidate profile Propose strategies and solutions to data issues or challenges that occur during the PSUR writing and conclusion process.