144 Cmc 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.

Description Regulatory Manager (CMC, EU & Japan/China) Syneos Healthis a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities, Our Clinical Development model brings the customer and the patient to the center of everything that we do We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for, Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives, Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program, We are committed to our Total Self culture where you can authentically be yourself Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people, We are continuously building the company we all want to work for and our customers want to work with WhyBecause when we bring together diversity of thoughts, backgrounds, cultures, and perspectives were able to create a place where everyone feels like they belong, Job Responsibilities Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients, No matter what your role is, youll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment Learn more about Syneos Health, http:// syneoshealth Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above Further, nothing contained herein should be construed to create an employment contract Occasionally, required skills/experiences for jobs are expressed in brief terms Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job, Show

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.

Skills: "Industrial Hydraulics", "Hydraulic Power Pack", "Hydraulic Circuit", "Mobile Hydraulics" "Pneumatics", Yuken, Hydac, Parker, Veljan, Danfoss, Eaton, Atos, Bucher, (Employed in Direct Brand or their Dealer), Hydraulic PumpsHydraulic MotorsTorque HubsValvesManifoldsPower UnitsCylindersAccumulatorsJoysticksFoot PedalsSpare Parts, Experience in Service sales, Concept of AMC & CMC Contracts, Analytical and conceptual capabilities, Experience in AUTOCAD, MS word/ EXCEL; Presentation skills,. Industry:Engineering. Location and no. of position:. Kolkata (areaWB)01. Guwahati (areaNorth East)01. Benefits:PF, Cashless Medical Insurance at all top Hospitals for Full Family. Qualification:Diploma or B.Tech Engg in Mech/ Elec. /Electronics. Industry Background. Relevant Skill/ Experience Fields:Industrial Hydraulics, Hydraulic. Power Pack, Hydraulic Circuit, Mobile Hydraulics Pneumatics. Relevant Brand:Yuken, Hydac, Parker, Veljan, Danfoss, Eaton,. Atos, Bucher, (Employed in Direct Brand or their Dealer). Production & Brand to be handled:Rexroth (A Bosch Company). *(Hydraulic PumpsHydraulic MotorsTorque HubsValvesManifoldsPower UnitsCylindersAccumulatorsJoysticksFoot PedalsSpare Parts.)*. Skills. Communication skills:Experience in Service sales is preferable. Concept of AMC & CMC Contracts. Analytical and conceptual capabilities. MS word/ EXCEL; Presentation skills. Experience in AUTOCAD. Responsibilities:1. Customer visit for application study. Installation Database collection and maintaining data. Repair Advice to Client. Drafting Scope of Work for AMC/ CMC. Submitting and negotiating Offers. Collect customer feedback about existing products. Conduct local market and competitor analysis

Primary Responsibilities: Responsible for finalizing the CMC regulatory strategies for assigned products and provide support to execute tasks independently in accordance with global regulations and guidance procedures. Serve as the CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones for assigned products through the product lifecycle. Execute regulatory strategies by leading the development, Review and approval of CMC submission components and documentation to support post-approval supplements, and responses to health authority questions per established business processes and systems. Lead the Change control evaluation, preparation, and submission of CMC dossiers for life-cycle changes to commercial products in support of project execution. Lead & plan the bundling/grouping strategy of variations and geo-expansion strategy of active Marketed products. Aid in the development and Lead execution of global product and project regulatory strategy(s) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks. Provide regulatory leadership as needed to product in-license/due diligence review, product divestment and product withdrawal. Collaborate with internal and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance. Manage execution of CMC documentation including complex post-approval variations, registration renewals and responses to health authority questions per established business processes and systems. Demonstrate a robust understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval and Product supply continuity. Assess and communicate potential regulatory risks and propose mitigation strategies. Deliver all regulatory milestones for assigned products across the product lifecycle Identify, communicate, and escalate potential regulatory issues to management, as needed. Demonstrate ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders. Demonstrate flexibility in responding to changing priorities or dealing with unexpected events. Demonstrate effective leadership, communication, interpersonal and negotiating skills in the most complex and fast-paced team environments. Experience required: Bachelor's / Master's / Ph. D. degree in science, engineering, or related field. 5+ years of experience is preferred. Strong experience in CMC registration and Pre & post approval submission activities. Proven experience in critically reviewing the supporting documents and data to ensure the adequacy for submission. Superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills. Sound understanding of related fields (e.g., manufacturing, analytical, quality assurance and other related fields) and the ability to be creative and imaginative in the approach to new and diverse problem solving. Relevant CMC pre/post approval experience, which may include research, manufacturing, testing, or licensure of products. Role & responsibilities Preferred candidate profile

Responsibilities: Manage service sales team & customer relationships Oversee warranty management & spares supply chain Ensure contract compliance & renewals Develop after-sales strategies & marketing plans Food allowance Health insurance Annual bonus Provident fund

":"Phd/ Doctorate, M.Sc. " , "process_Name":"R&D" , "vacancyKeyskills":" Ensure accurate analysis of samples in time Ensure that laboratory work is carried out in a safe manner. Ensure that equipment are in working condition all the time. Ensure that analytical division complies with relevant statutes. Ensure that knowledge generated is captured in an easily retrievable form. Ensure compliance of systems implemented. Ensure timely completion of Projects. ","vacancyKeyroles":" Execution of analytical plan for the assigned projects. Interpretation of analytical results and prepare analytical reports. Record and report the observations during analysis. Documentation of analytical work. Interact with synthesis division for the analytical requirements. Follow safety practices and procedures. Prepare and implement maintenance schedule. Maintain required level of spares and consumables. Propose AMC/CMC contracts and implement AMC/CMC contracts. Follow the practices and procedures as laid down by statutes. Follow systems for knowledge capture. Follow the systems. Data and report sharing Customer discussion Analytical requirement Response to customer queries

1. Warehouse Operations a. Ready to come in all shift timings b. Maintaining Receiving to Binning Ratio as per target c. Defining Storage and Picking Strategies d. Picking operations as per Customer orders e. Perpetual / Annual Inventory, Variance reporting & countermeasures to reduce variances f. Customers (Domestic / Exports) dispatches and quality delivery g. Maintaining Order to Dispatch Ratio h. Ensuring Safety, 5S, MHE Procurement & Maintenance in Warehouse i. Necessary approvals to run business (Purchasing of MHE, Service - AMC / CMC) j. Spare Parts Vehicle Unloading (Unloading TAT Monitoring) k. Maintaining Export Discrepencies at 0 level 1. Soft Skills - Inter-personal skills - Co-ordination within Division / Department / Vertical - Team-player - Out of the box thinking capability (creativity) - Presentation skills - DCM, New ideas

Position Title: Digital Product Owner Chemistry, Manufacturing and Controls (CMC) About Chemistry, Manufacturing and Controls CMC refers to the methods and tests used to ensure that a pharmaceutical product meets the required quality standards before it is approved for market use. It encompasses various aspects of drug development, including formulation, manufacturing processes, and quality control. About the Job We are looking for a Digital Product Owner to lead the development of innovative data products supporting Chemical, Manufacturing and Control operations. This role will work closely with the Product Owner CMC, focusing on enabling data-driven decision-making in CMC operations using the Data Mesh approach. The role requires close collaboration with other data teams, particularly in Manufacturing & Supply (M&S) and mRNA areas, to ensure alignment and synergy across data products. As the Product Owner, you will be responsible for collaborating with digital stakeholders, managing the full product lifecycle from gathering requirements to product delivery and continuous improvement. You will work closely with a dedicated agile team composed of data engineers to deliver high-impact digital products that empower cutting-edge data consumers in research and manufacturing. What you will be doing: 1. Product Ownership: o Under the supervision of the Senior PO, collaborate to the development and evolution of the CMC Data Product, ensuring it meets scientific, research, and business objectives. o Collaborate to the product roadmap, defining clear and actionable goals that align with the strategic direction of the company and the needs of the scientific teams. o Gather and prioritize requirements from scientists, technical stakeholders, and cross-functional teams to define the What and Why of product development. 2. Collaboration & Stakeholder Management: o Work closely with scientists, data engineers, and platform engineers to ensure the product meets both scientific and technical requirements. o Collaborate with senior leaders and cross-functional teams (including R&D, technology, and operations) to ensure alignment and ensure the product strategy is supported by business cases and industry standards. 3. Product Delivery: o Oversee the agile product development process, ensuring smooth product delivery from initial conception to ongoing iterations. o Partner with the Scrum Master and delivery team to ensure timely and successful sprints, address challenges, and resolve any ambiguities. o Manage backlog prioritization, balancing short-term deliverables with long-term goals and breakthrough ideas. 4. Continuous Improvement: o Track the performance and impact of the product post-launch, gathering feedback to drive continuous improvements and enhancements. o Monitor user satisfaction, adoption, and scientific outcomes to ensure the product evolves to meet the needs of researchers and business goals. 5. Technical Leadership & Strategic Vision: o Develop a strong understanding of CMC workflows and data integration needs, particularly in areas related to drug substance and drug product development, manufacturing, and quality control. o Support the vision for innovative solutions in CMC data management and analysis within the Data Mesh architecture. o Stay current with developments in data platform technologies, particularly Snowflake, and their applications in the pharmaceutical industry. Key Requirements: Experience: o 5+ years in product management, preferably with experience in life sciences, pharmaceutical development, or data platforms. o Experience working with scientific or technical products in regulated environments. o Familiarity with cloud environments and data platform technologies, particularly Snowflake. Soft Skills: o Strong drive and ability to articulate product vision and align teams around shared goals. o Excellent communication, presentation, and collaboration skills, particularly with scientists, engineers, and executive stakeholders. o Proven ability to make strategic decisions, overcome roadblocks, and deliver results in a fast-paced, complex environment. o Leadership skills to inspire and guide both technical and non-technical teams toward successful product delivery. Technical Skills: o Solid knowledge of Agile methodologies, including experience working in Scrum teams. o Familiarity with bioinformatics tools and ELN (Electronic Laboratory Notebook) systems o Strong understanding of Data Modelling, data integration concepts, and data engineering principles. o Experience with cloud platforms, AI platforms, and data pipelines is a plus. o Knowledge of GxP principles and their application in pharmaceutical data management is a plus. Education: o master s degree in computer science, bioinformatics, data science,or a related scientific field. Ph.D. or equivalent experience in relevant scientific domains will take into consideration

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

Job Title: Intern CMC (Formulation) Duration: 12 Months (1 year) Location: Hyderabad Department: CMC (Formulation) Reporting To: Lead Scientist - CMC (Formulation) Stipend: Paid Qualifications: Master s degree in Pharmaceutical Sciences (Pharmaceutics) or related discipline from a reputed institution. Strong academic background in pharmaceutics Basic knowledge of formulation principles and analytical techniques. Familiarity with regulatory guidelines (e.g., ICH, FDA, EMA) is an advantage. Proficient in MS Office (Word, Excel, PowerPoint) and scientific writing. Excellent communication, organizational, and problem-solving skills. Position Summary: The Formulation R&D Intern will support the development of pharmaceutical dosage forms through hands-on laboratory work, data analysis, and documentation. This internship is designed to provide comprehensive exposure to formulation science, regulatory requirements, and industrial practices in a dynamic and collaborative environment. Key Responsibilities: Formulation Development: Assist in the design and optimization of formulations for various dosage forms including tablets, capsules, suspensions, emulsions. Conduct pre-formulation studies such as solubility, pH stability, hygroscopicity, and compatibility testing. Participate in excipient selection and formulation trials based on physicochemical properties and target product profile. Laboratory Work: Prepare lab-scale and pilot-scale batches under supervision. Operate and maintain laboratory equipment such as mixers, granulators, tablet presses, and dissolution testers. Documentation & Compliance: Maintain accurate and detailed laboratory notebooks and batch records. Prepare technical reports and summaries of experimental findings. Ensure compliance with Good Laboratory Practices (GLP) Cross-Functional Collaboration: Work closely with Analytical R&D, Quality Control, Regulatory Affairs. Participate in project meetings and contribute to formulation strategy discussions Location: Ferring India FHPDC R

Skill required: Provider Network - Life Sciences Regulatory Operations Designation: Health Operations Associate Manager Qualifications: Any Graduation Years of Experience: 10 to 14 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 Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and rating, research and education, policies and procedures, quality assurance, patient services, and public relationsYou will be expected to 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 Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems Typically creates new solutions, leveraging and, where needed, adapting existing methods and procedures The person requires understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor or team leads Generally interacts with peers and/or management levels at a client and/or within Accenture The person should require minimal guidance when determining methods and procedures on new assignments Decisions often impact the team in which they reside and occasionally impact other teams Individual would manage medium-small sized teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualification Any Graduation

The ROOTS2 staff member will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. The ROOTS2 staff member will be responsible for varying levels of product support, including leading projects, based upon their experience level. Additional job responsibilities include: Lead submission for annual reports, facility registrations, facility renewals, and product renewals Interact with authors/reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions Preparing submission content plans for CMC submissions including, CMC IND/CTAs and amendments, new marketing applications, facility registration and renewals, post market supplements/variations, product renewals, Module 3 baselines, and annual report/notifications Coordination, preparation, collection and/or legalization of CMC country specific documents Document and archive CMC submissions and related communications in the document management system Initiate and maintain CMC product timelines at the direction of product lead Interface with the regulatory operations team Train staff on select CMC procedures and systems Provide report status of activities and projects to teams and department Participate in cross-functional special project teams Basic Qualifications: Master s degree OR Bachelor s degree and 1-2 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Associate s degree and 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR High school diploma / GED and 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: BS degree in Life Science Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development Regulatory CMC specific knowledge and experience Mature project management and organizational skills Strong and effective oral and written communication skills Experience in Veeva Vault platforms

Career Category Regulatory Job Description Let s do this. Let s change the world. In this vital role you will report into the Regulatory Compliance Team lead. The Regulatory Compliance Change Assessor will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams, as well as Amgen Operations, Quality, and/or Supply Chain for specific strategies or activities that impact a product. The Change Assessor will be responsible for varying levels of product support, including global reportability assessment of single or cross-product changes, based upon their experience level. Roles & Responsibilities: Key responsibilities of the Regulatory Manager include: Reviews change records to evaluate impact of the change with respect to reportability and product restrictions for any product in scope. Defines and documents the reporting and product distribution restriction requirements for the change within the change control management system. Liaise with other functions, including Process Development, Operations, Quality and Supply Chain to ensure alignment of regulatory strategies Provides expertise and guidance to interdepartmental and cross-functional teams Coaches and support junior regulatory staff s career development Identifies and implements process improvements for the change management process What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Doctorate degree OR Master s degree and 4 to 6 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Bachelor s degree and 6 to 8 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Diploma and 10 to 12 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: Degree in Life Science discipline Regulatory CMC specific knowledge & experience Understanding and application of principles, concepts, theories and standards of scientific/technical field Experience in manufacture, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Career Category Regulatory Job Description The Regulatory Compliance Change Assessor will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams, as well as Amgen Operations, Quality, and/or Supply Chain for specific strategies or activities that impact a product. The Change Assessor will be responsible for varying levels of product support, including global reportability assessment of single or cross-product changes, based upon their experience level. Roles & Responsibilities: Key responsibilities of the Regulatory Sr Associate include: Reviews change records to evaluate impact of the change with respect to reportability and product restrictions for any product in scope. Defines and documents the reporting and product distribution restriction requirements for the change within the change control management system. Liaise with other functions, including Process Development, Operations, Quality and Supply Chain to ensure alignment of regulatory strategies What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a type of person with these qualifications. Basic Qualifications: Master s degree OR Bachelor s degree and 2 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Associate s degree and 6 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Diploma and 8 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: Degree in Life Science discipline Regulatory CMC specific knowledge & experience Understanding and application of principles, concepts, theories and standards of scientific/technical field Experience in manufacture, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry .

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

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.

- Visit the customers for attending to technical jobs viz., repairs, refurbishing etc. - Work as per contracts GMC PMC CMC schedules - Support the service business by generation of sales of genuine spares - Customer satisfaction by fast response and quick service (minimum lead time) for long-term relationships. - Salvage the spare parts, understand recurring problems of the products,replacement of spares at customers site and sending back items under warranty to HO for proper accounting and documentation. - Provide training to customers operators about upkeepment, maintenance and safety of the equipment purchased by the customers - Educate and recommend to the customers on new products of the division. - Installation, troubleshooting & repairing Material Handling equipment. - Providing remote technical assistance to dealer technicians on need basis.

Profile: Medical Lab Incharge Onsite and Permanent Job description: Roles and Responsibilities: - Authorize release of test report based on the Buyers protocol & test methods - On time responds to Buyers & clients queries, emails and calls - Responsible for reviewing revisions, updates on test parameters, protocols and regulations, etc. and circulating these to the concerned lab team - Training lab staff as per updated, revised protocol received from clients and brands - Support team to develop capability on new test parameters as received in buyer protocol - Training & Supervising the handling, operating and maintenance of test equipment. - Supervising preparation and maintenance of document as per requirement of ISO 17025 - Monitor accuracy of ILC/ PT programs and timely delivery of Test results and Test reports - To monitor NABL and Buyers/ clients accreditation process & correlation activities - Responsible for efficient operations of testing lab. - Responsible for on-time delivery of test reports and maintaining TAT - Responsible for development of new test methods required as per revisions and updates - Seek approvals for revision of test reports, Invoices - Ensure AMC/ CMC for test instruments, Calibration tools, standard reference materials are in place. - Coordinate with QM/ Quality executive to respond and resolve customer complaints / claims, non-conformances and in the corrective and preventive action Exp.- 1-16yrs

Profile: Medical Lab Incharge Onsite and Permanent Job description: Roles and Responsibilities: - Authorize release of test report based on the Buyers protocol & test methods - On time responds to Buyers & clients queries, emails and calls - Responsible for reviewing revisions, updates on test parameters, protocols and regulations, etc. and circulating these to the concerned lab team - Training lab staff as per updated, revised protocol received from clients and brands - Support team to develop capability on new test parameters as received in buyer protocol - Training & Supervising the handling, operating and maintenance of test equipment. - Supervising preparation and maintenance of document as per requirement of ISO 17025 - Monitor accuracy of ILC/ PT programs and timely delivery of Test results and Test reports - To monitor NABL and Buyers/ clients accreditation process & correlation activities - Responsible for efficient operations of testing lab. - Responsible for on-time delivery of test reports and maintaining TAT - Responsible for development of new test methods required as per revisions and updates - Seek approvals for revision of test reports, Invoices - Ensure AMC/ CMC for test instruments, Calibration tools, standard reference materials are in place. - Coordinate with QM/ Quality executive to respond and resolve customer complaints / claims, non-conformances and in the corrective and preventive action Exp.- 1-16yrs

As the Regulatory Manager (CMC, EU & Japan/China) at Syneos Health, you will be part of a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. Our focus is on translating clinical, medical affairs, and commercial insights into tangible outcomes that address the realities of the modern market. In our Clinical Development model, we prioritize placing the customer and the patient at the center of all our activities. We strive to simplify and streamline our processes, not only to enhance our interactions with clients but also to create a more conducive working environment for our employees. Whether you are engaged in a Functional Service Provider partnership or operating in a Full-Service setting, you will collaborate with a team of enthusiastic problem solvers who are committed to innovating and assisting our clients in achieving their objectives. At Syneos Health, we are agile and have a strong drive to expedite the delivery of therapies because we are deeply passionate about making a positive impact on people's lives. As part of our company, you will discover the significance of working in an environment where your contributions matter globally. We are dedicated to the growth and development of our employees through various means such as career advancement opportunities, supportive and engaged line management, technical and therapeutic training, peer recognition, and a comprehensive rewards program. Our commitment to the Total Self culture ensures that you can be your authentic self at work. This culture unites us globally and underscores our determination to prioritize the well-being of our employees. By fostering a diverse and inclusive workplace that values different perspectives, backgrounds, and cultures, we aim to create a sense of belonging for everyone. In your role, you will have the opportunity to engage with the vast experience of Syneos Health. Over the past five years, we have collaborated on 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and conducted over 200 studies across 73,000 sites involving 675,000+ trial patients. At Syneos Health, we encourage you to challenge the status quo, take initiative, and adapt to the highly competitive and dynamic environment we operate in. We are continuously evolving and striving to become the company that everyone desires to work for and that customers prefer to work with. Our ultimate goal is to harness the power of diverse thoughts, backgrounds, and perspectives to create a workplace where everyone feels included and valued. Please note that the tasks, duties, and responsibilities outlined in this job description are not exhaustive. The Company reserves the right to assign additional tasks, duties, and responsibilities at its discretion. Qualifications may vary based on equivalent experience, skills, and education. The Company will determine what constitutes equivalence to the qualifications mentioned. This job description does not create an employment contract and is intended to comply with all relevant legislation, including the EU Equality Directive and the Americans with Disabilities Act. Accommodations will be provided as necessary to enable employees or applicants to perform essential job functions.,

This is a full-time on-site role for a Manager / Deputy Manager Regulatory Affairs located in Vadodara. As the Manager / Deputy Manager, your responsibilities will include developing and implementing regulatory strategies, ensuring compliance with regulatory requirements, preparing and submitting regulatory documents, and maintaining regulatory files. Your role will involve interacting with regulatory agencies, managing timelines, and ensuring that all products meet regulatory standards. Your key responsibilities will be to develop and direct global regulatory strategies for clinical, non-clinical, and CMC aspects. You will lead the preparation, review, and approval of submission documents for US FDA, EMA, Health Canada, Australia, and ANVISA. Providing strategic guidance on the impact of CMC changes on regulatory submissions and developing appropriate regulatory pathways will be crucial aspects of your role. Additionally, you will review and evaluate CMC documents, including specifications, batch records, stability data, and change controls. Collaboration with cross-functional teams to ensure regulatory compliance and timely submission will be essential. You will also participate in client discussions, training, and development activities as needed. Experience in handling teams and a total experience of 12 to 15 years is required for this role. Qualifications for this position include experience in regulatory strategy development and implementation, proficiency in preparing and submitting regulatory documents, a strong understanding of regulatory compliance, excellent organizational and timeline management skills, strong written and verbal communication skills, and the ability to interact effectively with regulatory agencies. Experience in the pharmaceutical industry is a plus, and a Bachelor's degree in Pharmacy, Chemistry, or a related field is required.,

Summary -Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation publication of REG CMC documentation for submissions to Health Authorities. In addition interact with HAs on REG CMC questions to support new product or post marketed launches. About the Role Major accountabilities: Formulate and lead global CMC regulatory strategy with a focus on innovation, maximizing the business benefit balanced with regulatory compliance -Lead and implement all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products. Identify the required documentation and any content, quality and/or timelines issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines. Author and/or review high-quality CMC documentation for HA submission, applying agreed CMC global regulatory strategies, current regulatory trends and guidelines. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements. Prepare and communicate CMC Risk Management Assessments, contingency plans, and lessons learned on major submissions and escalate with management as appropriate. Initiate and lead Health Authority interactions and negotiations as appropriate; setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans. Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) Produces high quality strategic project documentation and presentations; no late changes in strategy due to inadequate prior evaluation. No delays in approvals of clinical studies, global registration dossiers or variations due to late or inadequate submission documentation on matters within RA CMC control. Delivers reliable, timely and accurate information / communication about project specific issues within own department and to key stakeholders RA CMC regulatory documentation follows Novartis guidelines and meets regulatory guidelines. Provides high quality regulatory evaluation and strategic advice on time (change control, etc.); regulatory compliance met in all compliance systems. Maintains collaborative partnerships with stakeholders. Minimum Requirements: Cross Cultural Experience. Operations Management and Execution. Collaborating across boundaries. Project Management. Change Control. Cross-Functional Teams. Documentation Management. Negotiation Skills, Project Management, Regulatory Compliance. Risk Assessment. Why Novartis: You ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. Commitment to Diversity and Inclusion: Accessibility and accommodation Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https: / / talentnetwork.novartis.com / network Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:

Eurofins Scientific through its subsidiaries is a world leader in food, environment, pharmaceutical and cosmetic product testing, discovery pharmacology, forensics, advanced material sciences, and in agroscience Contract Research services. It is also one of the global independent market leaders in genomics and in the support of clinical studies, as well as in BioPharma Contract Development and Manufacturing. In addition, Eurofins is one of the key emerging players in specialty esoteric and molecular clinical diagnostic testing in Europe and the USA. With ca. 62,000 staff across a network of over 1,000 independent companies in 62 countries and operating over 900 laboratories, Eurofins offers a portfolio of over 200,000 analytical methods for evaluating the safety, identity, composition, authenticity, origin and purity of biological substances and products, as well as for innovative clinical diagnostics. The objective of Eurofins companies is to provide their customers with high-quality services, accurate results on time and expert advice by their highly qualified staff. Main Responsibilities "¢Sourcing Expertise & experience in CDMO/CMC/Chemistry/Toxicology "¢Exposure to import of Specialty chemicals from China "¢Extensive experience on Cost Sheets. "¢Experience in import and its related formalities to ensure timely clearances and delivery of imported Goods (Lab equipment"™s and chemical/consumables) "¢Procurement of Biologicals & Consumables "¢Liaison with Regulatory Authorities "¢Develop, lead and execute purchasing strategies. "¢Track and report key functional metrics to reduce expenses and improve effectiveness. "¢Craft negotiation strategies and close deals with optimal terms. "¢Partner with stakeholders to ensure clear requirements & documentation. "¢Forecast price and market trends to identify changes of balance in buyer- supplier power "¢Perform cost and scenario analysis, and benchmarking. "¢Assess, manage and mitigate risks. "¢Seek and partner with reliable vendors and suppliers. "¢Determine quantity and timing of deliveries. "¢Rate contracting of all Opex related requirements. "¢To arrange for vendor approval after obtaining of duly filled in Vendor Questionnaire "¢Ensure timely, cost effective and high-quality materials adhering to all purchase policies and regulatory guidelines. "¢Review and approval of Stores Records Competencies "¢Proven working experience in Biopharma industry. "¢Strong leadership capabilities "¢Working with teams, leading them "¢Senior profiles from the industry who has worked in a shared service profile and who has the potential of moving into a senior role in near future. "¢Comfortable and has worked in different industries and segments especially large MNC"™s and proprietor driven organizations. "¢Candidate who has managed purchase savings. "¢Candidates with dynamic personality and strategic purchase know how "¢Exposure to Techniques of Cost Reduction "¢Exposure to Techniques of Negotiation "¢Knows Key KPI"™s of purchase department. "¢Familiarity with sourcing and vendor management "¢Interest in market dynamics along with business sense "¢Working experience of vendor management software like Coupa. "¢Ability to gather and analyze data and to work with figures. "¢Solid judgement along with decision making skills. "¢Knowledge of Indirect and Capex procurements "¢Ambitious, looking for leadership role. "¢Has had lateral movements "“ Cross Industry "¢Entrepreneurship Skills "¢Comfortable working in a fast pace environment and who can put processes into place. Qualifications "¢Any graduate Diploma/Degree "¢BE/ MBA good to have.