182 Ra Jobs

Roles and Responsibilities: Preparation of RA Bills and getting it certified with concern Project Management Consultants & Cost Consultants Team. Responsible for study of BOQ (Bill of Quantity) as per specifications and taking out quantities from drawings Identification and preparation of extra items and coordination with procurement department To coordinate with account team for invoice preparation and bank guarantee Billing, Measurement & Reconciliation Reconciliation of material & bill checking as per the joint service measurement To verify the quantities of materials purchased as per Drawing. Reconciliation of materials as per bill & site inward challans. Preparation of Handing over Documents & Billing documents. Preparation of as build drawing as per site execution. To ensure recovery against the rework / faulty work from the contractors as per recommendation from site Maintaining of all important documentation Ensures that Company policies and project procedures in terms of billing are being adhered to All jobs as assigned by MD Qualification & Preferred Skills: BE/Diploma Electrical with 4-5 years of experience Excellent communication skill Teamwork & Leadership skills preferred IT Skills MS Excel, Word, PowerPoint. Familiarity with Google Workspace is preferred. Excellent in organizing & documentation skills Job Types: Full-time, Permanent

A leading and growing company in the field of High quality Cladding and Glazing solutions company from Mumbai is looking for suitable Male candidate as Billing Engineer Job Profile : Prepare and submit client bills as per contract terms (RA bills, final bills, etc.) Generate and verify subcontractor bills and ensure alignment with work progress. Ensure accurate quantity estimation based on drawings and site measurements (BOQ / DPR). Collaborate with site engineers, quantity surveyors, and procurement teams for material and cost tracking. Maintain records of work executed, certified quantities, and payment received. Reconcile materials and resources used on-site with billed quantities. Support audits by providing documentation and clarifications. Prepare MIS reports on billing and payment status. Ensure compliance with contractual terms and statutory norms. Desired Candidate : Education: Diploma or Bachelor's in Civil Engineering (B.E. / B.Tech) / Mechanical Engineer Experience: 4/7 years in billing, quantity surveying, or contract management. Software Skills: AutoCAD, MS Excel, MS Project, ERP (SAP / Tally preferred) Knowledge of CPWD / PWD / government billing norms is an advantage. Strong numerical, analytical, and documentation skills. Good communication and coordination abilities. Salary : As per the market norms If interested kindly mail us your updated resume with salary details and notice period to os.consultancy@hotmail.com

You will be working as a Core MS Specialist at Scorpedge Global IT Services in Chennai, TN. Your primary responsibility will involve managing day-to-day tasks associated with Microsoft technologies and systems. This includes providing technical support, troubleshooting issues, and performing maintenance activities to ensure the smooth functioning and reliability of IT systems. To excel in this role, you should have experience as a Cloud Deployment Engineer with expertise in CBIS deployment. Additionally, you should possess a good understanding of Openstack/AWS, along with strong troubleshooting and fault handling skills. Experience as a Charging Engineer with hands-on experience in Fault/Configuration handling in PCRF/RA/NCC/NPC will be beneficial for this role. Moreover, familiarity with Paco 5G SA and expertise in Nokia products, specifically in AMF/SMF/UPF/CMM/CMG, will be advantageous. It is important to note that hybrid experience is not required for this position, as the focus is on WFO in the NAM region. Ideally, this position is based in Chennai and involves working in 24*7 shifts following the NAM Shift schedule.,

We are looking for a QA Project Manager with a focus on Quality Assurance. Experience as a Project Manager in Life Sciences, Biotech, or Biosimilar Industry is essential for this role. The ideal candidate will be responsible for planning, coordinating, and implementing projects within the allocated budget, timeline, and scope. You will be required to effectively monitor project progress and provide updates to stakeholders, clients, or team members. Responsibilities include setting project timelines, monitoring deliverables, updating relevant stakeholders on project progress, and coaching project team members with assigned tasks. Qualifications: - Bachelor's Degree or equivalent experience - Strong business acumen in project planning and management - Excellent verbal, written, and organizational skills - Preference for candidates with experience in CGT driven companies Key Skills: - Project planning & execution: Managing timelines, resources, and deliverables across multiple projects - Risk management: Identifying, mitigating, and managing technical, regulatory, and operational risks - Cross-functional leadership: Coordinating across R&D, clinical, regulatory, manufacturing, and commercial teams - Background in life sciences (e.g., molecular biology, biochemistry, pharmacology) - Understanding of biotech R&D pipelines: Drug discovery, preclinical, clinical trials, and regulatory pathways - Ability to translate scientific data into actionable plans - Aligning project goals with company strategy and commercialization milestones If you meet the specified requirements and have the necessary experience, we encourage you to apply for this position.,

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.

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.

You will be responsible for handling production equipment including vial washing & Depyrogenation tunnel, Autoclave, Manufacturing, Steam air sterilizer, Laundry area, Vial coding (Domino), and external vial washing. Additionally, you will be in charge of the requalification/qualification of equipment such as autoclave, vial washing, and tunnel. Your duties will also include managing the auto CIP & SIP process of manufacturing tanks, as well as having knowledge about audit trails and data backup. Familiarity with computer systems like eBMR, PLC, and SCADA will be essential for this role. Furthermore, you should possess knowledge about change control, regulatory affairs, corrective and preventive actions (CAPA), and environment, health, and safety (EHS) activities. The ideal candidate will have a Bachelor's or Master's degree in Pharmacy, along with 4 to 8 years of experience in the field. Previous experience at Zydus for 12 to 24 months is preferred. This position is based in the Production Department at Zydus Pfizer in Ahmedabad.,

About The Role : Job TitleRegulatory Reporting Associate LocationBangalore, India Role Description Regulatory Reporting is responsible for establishing and maintaining control frameworks designed to manage regulatory - monitoring, surveillance, compliance, transaction monitoring and screening. As a Regulatory Reporting team member, you will be responsible for managing daily reporting tasks and remediation activities. 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 Participate in change and BAU activities. Perform daily reviews of exceptions within the SLAs. Ensure accurate investigation and timely escalations. Identify opportunities to create efficiency in the current process. Liaise with internal stakeholders for issue resolutions Participate in new system implementation and projects Review and update KOPs, SOPs etc. Keep track and maintain issue Jiras Prepare daily, weekly, and monthly MI. Your skills and experience Understanding of Transaction Reporting, Post Trade Reporting and Regulatory reporting framework Knowledge of Non-Financial Regulations. EMIR Refit & MiFID is a priority. Knowledge of Jira application Knowledge of Derivatives products Business Intelligence Skills (good to have) Alteryx, Tableau, SQL etc. Need to be aware and have and understanding of market, financial institutions, operations errors and risks. Must exhibit strong partnership skills. Team player, highly motivated, problem solver Inquisitive and analytical Strong communication skills Bachelors degree How well support you . . . .

We are looking for Regulatory Affairs - Executive / Sr. Executive handling Africa and Asia and will be based at Juinagar, Navi Mumbai. Minimum 5 Years in RA is must Roles & Responsibilities: 1. Dossier Preparation and Submission: Compile and review regulatory submissions in ACTD, CTD and formats. Ensure all regulatory documents are accurate, complete, and compliant with regulatory requirements. 2. Review of Plant and R&D Data: Review R&D data to confirm compliance with regulatory expectations and assist in developing effective submission strategies. 3. Regulatory Compliance and Updates: Stay informed of changes in Asian and CIS market regulations, ensuring timely implementation of updates to maintain compliance. Provide regulatory insights to internal teams on best practices for data management and documentation. 4. Documentation and Record Keeping: Maintain well-organized records of submissions, communications, and approvals. Use regulatory software and systems for document tracking, version control, and report generation. Education: 5 - 8 years of experience in regulatory affairs, focusing on Asian markets. Desirable Skills & Competencies: Attention to Detail: Ability to review and analyze technical documentation with precision. Collaboration: Effective communication skills for working with R&D, manufacturing, and quality assurance teams. Problem Solving: Proactive in identifying compliance issues and developing solutions to address regulatory challenges. Proficient in MS Office and regulatory documentation software. Interested candidates can apply or mail your resume. If you have good references you can share - Thanks & Regards, Vaibhavi Behere HR Department Titan Laboratories Pvt Ltd vaibhavi.b@titanpharma.com

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

Prepare, compile & submit dossiers for product registration, variations & renewals to regulatory authorities.Ensure compliance with current regulations, guidelines & standards for pharmaceutical products.Knowledge of CTD/ACTD format is must.

Role : Senior Executive Qualification: M. Pharma/B. Pharma Experience : 4 to 8 Years Location : Dholka, Gujarat Responsibilities 1. Preparation and submission of registration and re-registration dossiers as per country requirements of ROW (Preferable Russia, CIS countries and WHO) 2. Arrangement for indent of Samples, Packing Material specimen, Impurities, Reference Standards as per submission requirement. 3. Query evaluation and submission with respective countries requirement within the required time frame. 4. Establish coordination with other departments like QA/QC, R&D, Marketing and Purchase for ensuring the filings and query response within time frame. 5. Post approval activities: Submission of variations to the terms of marketing authorizations for finished products as per respective variation guideline. 6. Preparation of COPPs (Certificate of Pharmaceutical Product) and FSC to be submitted to Local FDA approvals. 7. Preparation of Tender documents. 8. Support for activities of contract manufacturing product Preferred candidate profile Must have experience in Pharmaceuticals Industries

Responsible for Quality Assurance , documentation , Audits , ISO 13485:2016, RA

Role & responsibilities Job Title: International Regulatory Affairs (IRA) Sr. Manager Location: Ahmedabad -HO Markets: CIS (Including EAEU), LATAM (Central and South America), Middle East, Africa, South East Asia. Key Responsibilities: 1.Prepare monthly regulatory MIS reports and present status updates, key metrics, and strategic insights to senior management. 2. Manage relationships with external regulatory consultants, in-country partners, submission vendors, and the external regulatory team to ensure timely regulatory filings and ongoing compliance. 3. Collaborate cross-functionally with Formulation, QA, QC, Packaging Development, Production, RA, PV, and BD teams for data collection, gap analysis, and submission readiness. 4. Liaise with regulatory authorities including (EU, CIS, LATAM, ROW, Asia) and others. 5.Develop and implement regulatory strategies across international markets (EU, CIS, LATAM, ROW, Asia, Middle East, and Georgia) to ensure timely submissions and approvals for product registrations and lifecycle maintenance. 6. Lead the preparation, review, and submission of CTD/eCTD/ACTD dossiers for multiple dosage forms including solid orals, injectables, topicals, and liquids for pharmaceutical and nutraceutical products, as per country-specific guidelines. 7.Manage lifecycle regulatory activities such as renewals, variations, line extensions, and prompt responses to health authority queries across global jurisdictions. 8.Maintain up-to-date knowledge of global regulatory and provide strategic recommendations based on updated guidelines and country-specific requirements. 9.Ensure regulatory compliance for labeling, artworks, inserts, and packaging as per regional regulations and internal quality standards. 10 .Support and participate in regulatory audits and inspections by ensuring the availability of complete and updated documentation and responses. 11.Lead and train junior regulatory staff, encourage cross-market knowledge transfer, and ensure consistent alignment with global regulatory processes and corporate objectives. Preferred candidate profile

1.To lead Regulatory affairs team engaged in dossier preparation in CTD and ACTD formats / and country specific format, DMF verification, technical data verification for all Latam and CIS , ROW Countries and other country as per company requirements. 2.Responsible for final review of dossier before submission. 3.To coordinate with technical team for documents required for dossier. 4.Responsible to gather data related for dossier through online sources, laboratories, manufactures etc. 5.Reviewing artwork for products as per relevant regulatory authority requirements. 6.To verify the text matter, including text for product information leaflets and labels for medicines in accordance with the regulatory and code of conduct requirements; 7.Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products. 8.Communicate regulatory information to multiple departments and ensure that information is interpreted correctly. 9. Collaborate cross-functionally with Formulation, QA, QC, Packaging Development, Production, RA, PV, and BD teams for data collection, gap analysis, and submission readiness. 10. Lead and train junior regulatory staff, encourage cross-market knowledge transfer, and ensure consistent alignment with global regulatory processes and corporate objectives. .

Responsibilities: * Design, develop, test and maintain SAP ABAP applications using Adobe Forms, BAPI, OData, BadiS, RAF, ECC, SAP SHANA, SAP FIORI, BRF+, CSS/JS, IDOC, ALV Reports, SmartForms and RFC. POST YOUR RESUME AT hr@akriyagroup.com

Dear All, We are looking candidates for our R&D Centre in Drug Regulatory Affairs for Europe market. Company Name : V-Ensure Pharma Technologies Pvt. Ltd Location : Koparkhairane Role & responsibilities 1. Head and mange EU including UK regulatory team 2. Handle & lead the team for successful approval. 3. Define regulatory strategy for EU filings 4. Preparation of regulatory strategy & checklist as per country specific requirements. 5. Coordinating with cross functional departments ADL/FRD/QA/AL to procure the documents for review and compilation. 6. Coordinating with BD/Client/Vendor as per documents requirement. 7. Reviewing all CMC documents for adequacy and accuracy before compilation/ submission of Dossiers. 8. Preparing, reviewing, compiling & submission of Dossier in CTD format/regional format as per country specific requirements. 9. Review & submit all the required documents Client and or as per market requirement. 10. Client/MOH queries response for successful approval. 11. Preparation & monitoring and submission of Post approval documents 12. Review of site transfer documents for successful approval. Preferred candidate profile Job Role : Manager / Sr. Manager DRA Qualification : B.Pharm / M.Pharm Candidate must have experience in Pharma Formulation company in DRA for EU market Perk & Benefits : Best on Industry Standard

We are looking for a skilled Technical Manager with 4 to 7 years of experience to join our team at Equitas Small Finance Bank in the BFSI industry. Roles and Responsibility Manage and oversee technical projects from initiation to delivery, ensuring timely completion and quality results. Collaborate with cross-functional teams to identify and prioritize project requirements. Develop and implement technical solutions to meet business needs, leveraging expertise in BFSI technologies. Provide technical guidance and support to junior team members, promoting knowledge sharing and skill development. Analyze project performance data to inform decision-making and optimize processes. Ensure compliance with regulatory requirements and industry standards in all technical aspects of the bank's operations. Job Requirements Strong understanding of BFSI technologies and their applications in financial services. Proven experience in managing technical projects with a focus on delivering high-quality results. Excellent leadership and communication skills, with the ability to motivate and guide teams. Strong analytical and problem-solving skills, with attention to detail and strategic thinking. Ability to work effectively in a fast-paced environment, prioritizing multiple tasks and deadlines. Experience working with small finance banks or similar institutions is highly desirable.

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

1. Prepare, review & submission of quality regulatory dossiers in CTD/eCTD format for Europe & other markets. 2. Support product development, registration, & lifecycle management in Europe 3. Manage Regulatory Compliance & Approvals Required Candidate profile 1. Minimum 10 years of experience in Formulations OSD 2. Willing to work in Chennai 3.Strong expertise in European, EMA, MHRA & other international regulatory framework 4.Knowledge of ICH & regulatory

Dear Doctor's, We have excellent opportunities for freshers & experienced of "Anaesthesiologist" in Various Super & Multi Specialty Hospital and Diagnostic Center of Various with good Package & Accommodation + Incentive. Job: Title: Anaesthesiologist Qualifications: MBBS- MD/DA/DNB Package: Upto - 30 to 45 LPA Location: Chhattisgarh - Surajpur, Mungeli. Madhya Pradesh - Mandsaur Maharashtra - Nanded Rajasthan - Dudu Position Type : Full Time Skills: Anesthesiologist, OT, Critical Care, Emergency, Casualty, Intensive Care, Operation Theater, GA, RA, MAC, breathing management (mask ventilation, intubation, LMA), pain management, hypotension, anaphylaxis. Preferred Skills: Experience with a variety of surgical procedures and anesthesia techniques. Benefits: Competitive salary and benefits package. Opportunities for professional development and continuing education. Supportive and collaborative work environment. How to Apply : Interested candidates should submit their resume and a cover letter to Mail ID- jobs@angplacement.in Thanks & Regards, Jagdish Teli Managing Director 9993872666/ 7000476894 ANG Placement & Staffing Solutions Pvt Ltd.

Roles and Responsibilities Should Have Formulation Experience. Having vacancies in RoW (ASIA , MENA, LATAM, AFRICA) Regions Responsible for product registration RoW (ASIA , MENA, LATAM, AFRICA) Regions region Preparation, compilation and review of dossiers for region in eCTD/CTD/country specific format. Co-ordinating with cross functional departments like API, R&D, QC, QA, PDD, Micro for documents required for dossier compilation for initial submission, query responses or other submission like tender activities. Communicating with agents/partners for submission of Dossiers and further updates or requirements if any on product registration. Responding to queries with in the time lines received from client/agency. Preparation of check list as per country specific requirements region. Review of documents like specifications/ MFC/ BMR/ PV/ Stability/ PDR/ DMF/ CoAs/Artworks and other quality related documents for their suitability for registration in MENA region. Co-ordinating for CoPP, GMP, License and other required documents/certificates legalization activity required for dossier compilation and registration. Archiving/Maintenance of the dossiers, renewal files and variation approvals along with supporting documents in regulatory data base. Identifying gaps in approved dossier, compiled and submit the post approval changes (Minor variations) to agent/agency. Filing of variations if any and registration renewals. Compilation and circulation of product approval package up on receipt of product approval/Minor variation approvals to concern departments. Maintaining the product status (Registered and Under registration) in excel sheet. Desired Candidate Profile Should Have Regulatory Affairs Relevant Formulation Experience Perks and Benefits

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

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)