115 Cmc Jobs - Page 4

What you will do Let’s do this. Let’s change the world. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen’s CMC submission execution team, Regulatory Optimization of Tactical and Strategic Support (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC submission execution for Amgen products across phases of development, modality, and countries. In this vital role you 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 Potential to oversee or manage staff Act as a primary point of contact for specific submission execution or annual reporting tasks, including but not limited to, developing, documenting and maintaining process documents, training and onboarding new staff, and/or coordinating with impacted cross functional teams 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, postmarket 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 What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree and 1 to 3 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industryOR Master’s degree and 4 to 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Bachelor’s degree and 6 to 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: Experience managing or overing staff members 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 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. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Christian Medical College is looking for MCTT Trainee to join our dynamic team and embark on a rewarding career journey Learn MCTT processes and standards Assist in technical operations Gain hands-on experience Ensure compliance with protocols

Christian Medical College is looking for Staff III Graduate Technician to join our dynamic team and embark on a rewarding career journey Support laboratory experiments Ensure equipment maintenance Document experiment results Assist in research activities

Oversee the preparation, review, and submission of regulatory filings, including DMFs, ANDAs CTD submissions, and other relevant documentation. Document review Preparation and submission of DMF to various countries. Review & verification of BPCRs , PVP/PVR and method validation reports. Regularly updating and maintaining regulatory work sheets for monthly management review. Review and compiling vendor Qualification Documents and ROS etc. Review and compiling of CMC documents. Gathering and reviewing documents received from QA and other departments. Compilation of technical Data Packages, Quality Overall Summary & Open Part DMFs. Preparing US DMFs for USFDA, ASMF, CEP etc. Preparing Customer query response to AP/OP DMfs & TDPs raised by various customers. Preparing Applicant Part/ Open Part DMFs to various Customers. Preparation of LOAs LOEs, others declarations & commitment based on customers.

Staff III Instrument Technician for the Department of Urology (CMC Vellore, Ranipet Campus) Qualification: H.Sc., with Two Year Diploma in Urology Technician Course only from the recognized board and those who have completed 4 years of experience as Jr. Instrument Technician (Term Appointment) or equivalent only need to apply. Salary Scale : Rs.12762 - 510 25512 + DA HRA as per rules. Age Limit: Below 35 years Note: Only Regular mode will be accepted, Private or correspondence will be not accepted. 31/03/2025

Description Allianz POC 3 CMC - MD Expert Business Partner-C2#31 Deliverables Map existing local Business Partners to harmonized Business Partners - Identify gaps - Request from the OE missing BPs - Delete obsolete BPs - Perform Regression test Named Job Posting? (if Yes - needs to be approved by SCSC) Additional Details Global Grade D Level To Be Defined Named Job Posting? (if Yes - needs to be approved by SCSC) No Remote work possibility No Global Role Family 60236 (P) Software Engineering Local Role Name 6361 Software Engineer Local Skills 37116 SAP Finance Languages RequiredEnglish Role Rarity To Be Defined

JOB DESCRIPTION JOB TITLE Maintenance Executive-BHS LEVEL & GRADE B1 & B DIVISION/ DEPARTMENT Engineering & Maintenance /Mechanical COST CENTER 72180 REPORTS TO P Mohana Sundaram DATE 17/03/25 JOB PURPOSE (Provide an overview of the job, its context in the organization and the contribution that it makes) Responsible for day-to-day operation and maintenance/Comprehensive Maintenance activities, repair, troubleshooting, Inspection work of various Mechanical Installations. Having specialization skill & experience in Baggage handling system (BHS) in any large industry/organization. Also, having experience in one or more of the Mechanical Airport installations such as Passenger Boarding Bridges, Elevators & Escalators, Travelator (VHT) , Fire Protection System, Heating Ventilation and Air conditioning etgc. Co-ordination & Involving in both T1 & T2 Mechanical Maintenance activities. PRINCIPAL ACCOUNTABILITIES (List the responsibilities/ duties associated with the job and the major activities associated with each responsibility. For each responsibility/ duty listed, give the factors on which an individuals performance is judged) Accountabilities Major Activities Timely Review of Installations and maintenance task Compliance of Mechanical department activities with national and international standards Effective Maintenance planning and ensure timely Completion Having specialist knowledge & experience on Baggage Handling System (BHS) Having expertise on BHS SCADA, Self Bag Drop (SBD), Departure & Arrival Conveyor Systems, Baggage Sortation Process, Check-in Conveyors, Baggage Diverter system, Tilt Tray Sorter (TTS), Baggage Conveyor, Power Curve System, High Speed Diverter (HSD), Vertical Sorter Unit (VSU), Baggage Carousel etc Having exposure in trouble shooting of BHS system Carrying out scheduled maintenance, breakdown maintenance & predictive maintenance of Mechanical Installations (i.e. VHT, FFS, BHS, PBB & HVAC). Contract management of Mechanical Installations like HVAC, FFS, BHS, PBB & VHT Ensure serviceability of all Mechanical Installations as per Contract agreement including HVAC, FFS, VHT, PBB & BHS Co-ordination with the Project team/EPC/Design Team for any DLP & other additional improvement activities on Mechanical Installations. Effective Implementation of IMS (QMS, EnMS, EMS etc) Ensure that suitable Planned Preventative Maintenance (PPM) Plans are developed and implemented on Mechanical Installations Ensure that the Maintenance plan is fully documented and uploaded into SAP, ePalm. Ensures timely closing of entire mechanical department maintenance work orders(in SAP) during shifts Ensure updation of all maintenance documents Contract Management: efficiently and professionally manage contracts To ensure the labour regulations in the contract, legal & Statutory compliance Compliance; coordinates with Daily operation and contractors Training to Staff Training to staff in the troubleshooting & personal safety Develops, implements and trains staff; instructs staff in regulations, codes and work techniques and the proper use and maintenance of all equipment Effective Spare Parts Managements Availability and proper storage of all identified key spare parts Spare parts Planning cost, criticality Analysis Spare parts control-Regularly/irregularly used spare parts Ensures availability of adequate materials to conduct work activities; approves and/or initiates orders for new/replacement materials. DIMENSIONS (Financial or Non-financial parameters which are directly impacted/controlled by the role or indirectly influences/contributes to in a measurable way) Financial (Eg: Budgets, project costs, capex etc.,) Non-Financial (Eg: No. of direct/ indirect reports, headcount in projects, no. of clients handled etc.,) OPERATING NETWORK (Internal/ External contact groups with which the position holder interact/ work for achieving the organizations objectives) Internal External External Contractors Concessionaries Suppliers, vendors JOB SPECIFICATION 5.1.Education qualification and certifications (Indicate the level of education and certifications required) Degree/Diploma in Mechanical/Electrical/Electronics Engineering or Equivalent 5.2. Years of Experience ( Years of relevant experience required) Degree Holders: Should have Minimum 3 years of relevant working Experience in a large industry/Airport/corporate sector. Diploma Holders: Should have Minimum 6 years of relevant working Experience in large industry/Airport/corporate sector. 5.3. Computer skills (Indicate the required knowledge on software, applications, hardware etc., that are required) MS-Office (Word, Excel, Power point, Outlook) 5.4. Knowledge and work skills [Indicate what knowledge (machines, equipment, processes, systems etc.,) and work skills are required] Working experience in operation & maintenance of Baggage Handling System. Having expertise/experience in BHS SCADA, Self Bag Drop (SBD), Departure & Arrival Conveyor Systems, Baggage Sortation Process, Check-in Conveyors, Baggage Diverter system, Tilt Tray Sorter (TTS), Baggage Conveyor, Power Curve System, High Speed Diverter (HSD), Vertical Sorter Unit (VSU), Baggage Carousel etc Good knowledge in contract management like processing of bills ensures labour legal compliance, ensures proper wage disbursement to contract staffs by contractor etc. Good knowledge in preparation preventive maintenance schedule, execution as per schedule, maintaining of maintenance records, allocation of works to subordinates etc. Good knowledge in identify, procure & maintenance of spares Should have knowledge in Airport Operations in its totality - like movement of aircrafts, Check in process etc. Excellent Communication Skills in English (Verbal & Written) Behavioral Competencies (Behavioral competencies are qualities and skills that describe ‘how’ the job is to be performed. These qualities and skills translate into on-the-job behaviors that lead to superior and effective performance. There are 6 organizational competencies for BIAL that describe specific qualities and skills required by the position holder. Mention the level as skilled, proficient, advanced or expert as applicable, and if the competency is not required, then mention n.a.)

Christian Medical College is looking for Jr . Radiotherapy Technician to join our dynamic team and embark on a rewarding career journey A Radiotherapy Technician, also known as a Radiation Therapist, is responsible for administering radiation therapy to patients as prescribed by a radiation oncologist Here's a sample job description (JD) for a Radiotherapy Technician:Job Title: Radiotherapy TechnicianJob Overview:As a Radiotherapy Technician, you will be responsible for delivering radiation therapy treatments to patients with cancer, working closely with radiation oncologists, medical physicists, and other healthcare professionals You will ensure the accurate and precise administration of radiation therapy while prioritizing patient care and safety Responsibilities:Treatment Planning:Collaborate with radiation oncologists and medical physicists to develop and implement patient-specific treatment plans Review and verify treatment plans for accuracy and completeness Treatment Administration:Administer prescribed radiation therapy treatments using linear accelerators and other specialized equipment Ensure proper patient positioning and immobilization for accurate treatment delivery Monitor and adjust equipment settings to achieve the desired radiation dose Patient Care:Educate and support patients regarding the radiation therapy process, potential side effects, and self-care measures Monitor and assess patients for any adverse reactions during and after treatment Provide emotional support to patients and address their concerns Quality Assurance:Perform quality assurance checks on radiation therapy equipment Participate in quality improvement initiatives to enhance the safety and effectiveness of radiotherapy services Documentation:Maintain accurate and detailed records of treatment plans, delivery parameters, and patient responses Ensure compliance with regulatory and documentation requirements Radiation Safety:Adhere to radiation safety guidelines to minimize exposure risks for patients and staff Implement safety measures and protocols for handling radioactive materials

About the department Regulatory Affairs CMC play an important role in ensuring that all new Novo Nordisk treatments and devices are developed with compliance and the patients in mind. Liaising between relevant authorities and Novo Nordisk stakeholders, Regulatory Affairs CMC are involved throughout all phases of product development and roll-out. Our people in Regulatory Affairs come from many different academic and professional backgrounds, bringing valuable insights and expertise to the team and the company to ensure minimum time to market. This makes Regulatory Affairs a truly multi-disciplinary place to work with high professional standards, excellent opportunities for fast-paced professional development and career opportunities. The Position As a Senior Regulatory Professional, the candidate will be responsible for providing strategic input to RA CMC activities. One should have demonstrated ability to identify better practice and create improvements in methods, techniques, approaches etc. The professional will be required to handle most situations independently but will seek advice and guidance on complex issues. Further responsibilities include handling the change requests, query responses and provide strategic input at various forum representing RA CMC. Support preparation and submission of regulatory files, response to questions from health authorities and maintenance of marketing authorization globally. Negotiate with the regional affiliates on HA requirements and timelines. Manage stakeholders from across the organization including product supply. Hands on experience with Veeva vault and RIMS. The candidate will play a key role in stakeholder management and will be responsible for ensuring appropriate use of communication channels to strengthen relationships with the stakeholders. Experience 9+ years of experience within Regulatory affairs CMC with Graduate / Postgraduate degree in science/ pharmacy/ medicine etc. Experience of working in a Biologics company is preferred. Good understanding of end to end regulatory processes and life cycle management. Strategic mindset with proven negotiation skills. Should be able to convince and put forward the facts confidently. Highly proactive and able to take initiatives & manage multiple priorities. Self-managed, strong personal drive and ability to engage with colleagues and peers towards delivering excellent performance and results. High cultural sensitivity and comfortable working with different countries and cultures across multiple time-zones. Excellent written/spoken communication skills.

Role & responsibilities Job description Ensure that a company's products comply with the regulations of the regions. Keep up to date with national and international legislation, guidelines and customer practices Respond to queries from Centre for Veterinary Medicines (CVM). Collect, collate and evaluate scientific data from FR&D, AR&D and DQA. Develop and write clear arguments and explanations for new product licences and licence renewals at R&D site. Prepare submissions of licence variations and renewals to strict deadlines as per CVM. Monitor and set timelines for licence variations and renewal approvals Advise scientists (AR&D, FR&D, Pkg.-R&D) on regulatory requirements. Provide strategic advice to senior management throughout the development of a new product Review company practices and provide advice on changes to systems if any. Liaise with manager, and make presentations to, regulatory authorities, if any. Negotiate with regulatory authorities for marketing authorisation Take part in the development of marketing concepts and approve packaging and advertising before a product's release. Prepare the CTD sections of the dossier and ensure timely filing as informed by the functional head and Head -R&D. Review the data and check for its alignment and compliance from regulatory point of view as per CVM. Ensure the regulatory filing grid as shared by Functional head and Head-R&D is met on timely way and in complete regulatory compliance. Collaborate with FR&D, AR&D, Pkg-R&D on regular basis and together ensure the timely filing of products.

Christian Medical College is looking for Senior Resident/Assistant Professor to join our dynamic team and embark on a rewarding career Journey Patient Care: Provide comprehensive medical care to patients under the supervision of attending physicians Perform physical examinations, diagnose medical conditions, develop treatment plans, and monitor patient progress Clinical Supervision: Supervise and provide guidance to junior residents, interns, and medical students in their clinical duties Assist in their training, evaluation, and professional development Hospital Rounds: Conduct regular hospital rounds to assess patients, review test results, and discuss treatment plans with the healthcare team Coordinate and communicate patient care plans with nurses, specialists, and other healthcare professionals Medical Procedures: Perform or assist in various medical procedures, such as venipuncture, wound care, suturing, and bedside procedures Ensure adherence to sterile techniques, safety protocols, and best practices Medical Documentation: Maintain accurate and up-to-date medical records, including patient history, physical examination findings, treatment plans, and progress notes Ensure compliance with legal and regulatory requirements Patient Education: Educate patients and their families about their medical conditions, treatment options, and preventive measures Provide counseling on lifestyle modifications, medication management, and post-discharge care instructions Interdisciplinary Collaboration: Collaborate with other healthcare professionals, including nurses, pharmacists, therapists, and social workers, to ensure coordinated and holistic patient care Participate in interdisciplinary team meetings and contribute to care planning Continuity of Care: Facilitate smooth transitions of care between inpatient and outpatient settings Coordinate follow-up appointments, referrals, and discharge planning to ensure continuity of care and optimal patient outcomes Medical Research and Education: Stay updated with the latest medical advancements, evidence-based practices, and clinical guidelines Engage in research activities, present at conferences, and contribute to medical education and scholarly activities Quality Improvement: Participate in quality improvement initiatives to enhance patient safety, clinical outcomes, and healthcare delivery Identify areas for improvement, implement evidence-based practices, and contribute to quality assurance programs Professional Development: Engage in continuing medical education (CME) activities, attend conferences, and pursue opportunities for professional growth Maintain licensure and board certification requirements

Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : SAP UI5 Development Good to have skills : NA Minimum 2 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Developer, you will design, build, and configure applications to meet business process and application requirements. You will be responsible for ensuring that the applications are developed according to specifications and delivered on time. Your typical day will involve collaborating with the team to understand the requirements, designing and developing the application, and testing and debugging to ensure its functionality and performance. Roles & Responsibilities: Expected to perform independently and become an SME. Required active participation/contribution in team discussions. Contribute in providing solutions to work related problems. Collaborate with the team to understand the application requirements. Design and develop SAP UI5 applications based on the specifications. Test and debug the applications to ensure functionality and performance. Collaborate with cross-functional teams to integrate the applications with other systems. Provide technical support and troubleshooting for the applications. Stay updated with the latest trends and advancements in SAP UI5 development. Assist in documenting the application design, development, and maintenance processes. Professional & Technical Skills: Must To Have Skills:Proficiency in SAP UI5 Development. Good To Have Skills:Experience with SAP Fiori, JavaScript, and HTML5. Strong understanding of SAP UI5 framework and architecture. Experience in developing responsive and user-friendly UI5 applications. Knowledge of SAP ABAP programming language. Familiarity with SAP Gateway and OData services. Experience in integrating UI5 applications with SAP backend systems. Ability to troubleshoot and debug UI5 applications. Knowledge of UI design principles and best practices. Additional Information:-Strong hands-on experience in developing custom UI5 apps-Proficiency in Fiori Launchpad configuration and customization.-Strong knowledge of JavaScript, HTML5, CSS3, and OData services.-Ability to work in a team-oriented, collaborative environment. Qualifications 15 years full time education

Green Earth Exim India Pvt. Ltd is looking for Area Sales Manager 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 companys 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

Role & responsibilities: Compilation and review of registration dossiers as per Country specific guidelines and requirements. Specific experience required for Latam American market including Brazil, Mexico. Should have to work for EU market and hands on experience about the submission Management system. Review of all Technical Documents (DMF, Product Development Report, BMR, BPR, Analytical Method Validation Report, Specification-STP, Stability Report, BE Study Report etc.) Compilation of deficiency responses of new product submission and Backlog dossier To review the proposal for any post-approval changes as per the current regulatory guidance. To prepare and submit the variation for post approval changes. To communicate and follow up with overseas regulatory team /agent/ distributors to ensure timely filing of new submission or variation. To review various artworks & comments for ongoing commercial supply & products for the new launch. To prepare and maintain various registration Data base & updating at Central Depository. Preferred candidate profile: Candidate must have core International Regulatory Affairs experience in Latam and EU market can only apply. Candidate should have good technical job knowledge of EU and other regulatory. Should have good communication and interpersonal skills

Description Mandatory Skills: (MUST HAVE SKILLS) Experience with design and development of SAP Fiori, UI5 applications Experience with the SAP CAP framework, Fiori Launchpad, SAP BTP and its services especially workflow, Cloud Foundry and Kyma Experience with the OData API for SuccessFactors is a plus Strong analytical skills, personal drive and ability to deliver quality work IT Software Development or similar background and have several years of experience working in an international organisation with a complex IT environment.. Named Job Posting? (if Yes - needs to be approved by SCSC) Additional Details Global Grade C Level To Be Defined Named Job Posting? (if Yes - needs to be approved by SCSC) No Remote work possibility No Global Role Family To be defined Local Role Name To be defined Local Skills SAP BusinessObjects Languages RequiredENGLISH Role Rarity Niche

Additional Locations: N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we ll give you the opportunity to harness all that s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we ll help you in advancing your skills and career. Here, you ll be supported in progressing - whatever your ambitions. About the Role: Drive the capital equipment modalities of the Intervention Cardiology business, namely Rotablator and IVUS Imaging. Driving therapy advancement by promotion the usage of these modalities for driving better patient outcomes. Location: Bangalore, India Responsibilities & Requirements: Drive ROVUS therapy advancement across assigned territory in most compliant and efficient way. This will include effective Capital equipment demonstration during live case support, In-vitro Wet heart simulation, presentation on product in-service and execution of ROVUS training for Account Manager s, Cath Lab technicians and HCP s. Effectively implement TAG therapy advancement strategy for the incremental ROVUS consumables business in all BSC ROVUS installations in assigned region. Develop in-depth knowledge on ROVUS Therapy and should have optimal understanding of key competition for IVUS, FFR/DFR and Rotablation therapy. Ability to effectively manage product approvals and availability at new Cath Labs in coordination with BSCI Warehouse and authorized Channel Partners. Work in sync with the IC Sales Team. Achieve assigned overall TAG Target for the territory / region assigned, including Capital equipment and ROVUS Consumables business adhering BSCI compliance policy. Work closely with the IC sales team to identify opportunity in potential accounts as defined in strategic map for Rota, IVUS and FFR. Proactively prepare and work on closure of the CE Funnel leads in coordination with internal and external stake holders. Extend help and support to the Govt (GAM) / Private (KAM) tender management team to ensure that we get qualified in tenders with our technical specifications and win in most compliant way. Periodic review on the CE Funnel Leads in assigned region and timely status updating of the new Capex leads on SFDC portal in alliance with IC Sales Team, Channel Partners and Cath Lab companies. Work with IC Team and ROVUS Academy training team to drive the ROVUS trainings at BSC IAS Facility, COE s and ROVUS Workshops in assigned territory. Communicate and support Service team in getting AMC/CMC quote submitted with the existing installation user facility. Work with service engineer/s to execute the New Capital Equipment installation at user facility and minimize down time of Capital equipment in assigned territory. HCP and Key stakeholders call logging in the SFDC portal on a daily basis Requisition ID: 600835 As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen. So, choosing a career with Boston Scientific (NYSE: BSX) isn t just business, it s personal. And if you re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

Location based at Bangalore to take care of Karnataka, Telengana .Tamilnadu, Kerala Responsible for meeting monthly targets of Service Business (Comprehensive Monthly Contract/ Annual Maintenance Contract/ Repair Business/ Consumable Business) for South II region consists of Karnataka, Telangana Kerala. Evaluate budget proposals and manage purchases and expenses Represent the company to clients at meetings, conferences and sales negotiations Communicate with every department regularly to handle problems, identify new opportunities and build trust and transparency Assess employee performance and provide ongoing training and development programs Engages the customers through scorecards and f2f reviews Participates in internal commercial discussions related to services Regularly communicates with TS employees Drive South II AR by sending weekly/ monthly AR reports Sets up daily / weekly / monthly reviews with the South II team Generate reports on TS business analytics and share with the team PM compliance for govt hospitals for South II Enables inputs for the quarterly forecast Challenges team on opportunities for improvement on revenue Reviews monthly cost and identifies opportunities for improving cost base Identify opportunities on improving contract profitability Leads AR recovery discussions internally and eliminate bad debts Engages customer on long term contracts Abide by the price list, credit policy endorsed by finance for CMC repairs Builds install base for all the active equipments across South II region for contracts sales Lead annual goal setting in line with the regional expectations

Job Title: iCMC Regulatory Affairs Manager I Career Level - D1 Introduction to role As an iCMC RA Manager I, you will effectively handle the production of Chemistry, Manufacturing, and Control (CMC) documentation for designated product ranges to meet the needs of both AstraZeneca and our customers. You will project manage international CMC regulatory submissions, ensuring that project activities and documentation are delivered to the required standards across the product lifecycle. You will chip in to and lead the regulatory CMC components of business-related projects, maintaining effective communication with collaborators and project team members to ensure relevant timelines and regulatory commitments are met. Additionally, you will ensure the application of international CMC regulations and guidance within AstraZeneca and chip in to the development of new guidance, policy, and processes. Accountabilities Manage the timely preparation (including authoring) and delivery of CMC contributions to regulatory submissions linked to medicinal products throughout the lifecycle, including marketing authorization applications and all post-approval activities. Accountable for delivering submission ready CMC modules to internal and external regulatory team members in compliance with relevant AstraZeneca systems and procedures, ensuring submission quality. Document maintenance and communication of Health Authority approval status. Develop and build expertise in regional regulatory requirements to ensure compliance of CMC submissions. Demonstrate project management expertise with the ability to adapt to changing situations to ensure on-time delivery. Share learnings from own projects with colleagues/within functions. Support the agreed strategy to employ fit-for-purpose content applying regulatory intelligence and optimize proposed submission content. Participate in regulatory execution and delivery meetings, providing relevant updates to the CMC team. Contribute to business process optimization activities to reduce waste and ensure efficiency. Continually evolve and develop regulatory expertise through proactive recording and communication of Health Authority interactions, responses, and commitments. Apply GxP principles according to the stage of the product lifecycle. Responsible for organisational change as assigned. Understand the application of appropriate risk management across own activities. Demonstrate research skills in understanding regulations and guidance from different regulatory agencies. Essential Skills/Experience University degree in a science or technical field such as pharmacy, biology, chemistry, or biological science. Minimum 8 years of proven experience from the biopharmaceutical industry or other relevant experience. Breadth of knowledge of manufacturing, project, technical, and regulatory management. IT skills. Collaborator & project management. Professional capabilities: Regulatory knowledge. Desirable Skills/Experience Knowledge of the drug development process and regulatory submissions. Understanding of current regulatory CMC requirements. Direct/indirect Regulatory Affairs CMC experience with submissions for synthetics and/or biologic and biotechnology-derived products such as monoclonal antibodies or complex biologic products. Understanding of regulations and guidance governing the manufacture of biotechnology products, especially monoclonal antibodies. Lean capabilities. When we put unexpected teams in the same room, we fuel ambitious thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace, and challenge perceptions. Thats why we work, on average, a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. At AstraZeneca, we are committed to turning our drug development strategies into reality. We work at all stages of development to translate our life-changing science into medicines that achieve the best results for patients in need and healthcare professionals. Our innovative mindset drives us to think broadly about patients and what it takes to prevent and treat diseases. We are a diverse and open-minded team that values different skills and experiences, empowering us to make quick decisions and influence drug development strategies. Our science-driven approach ensures that our regulatory strategy is appreciated and valued, allowing us to bring life-changing medicines to patients. Ready to make a difference? Apply now to join our dynamic team! Date Posted 18-Mar-2025 Closing Date 22-Apr-2025

Flash Viven Machining Technologies Pvt Ltd FREE JOB! FREE JOB Company Name- Flash Viven Machining Pvt Ltd Job Location - Mahalunge Chakan Pune Qualifications ITI Turner ,Machinist ,Fitter, Grinder CNC VMC : 15,000/-to 16000/_ Diploma All : 16,000/- Facility Canteen & Bus 8 / 12 Hours Duty JOB ROLL Production Opretor CNC / VMC / Machine Opretor / Contact Number: Hr Aasha Mam : 86248 17374 Hr Sapan Mam: 92265 62301 Hr Sakisha Mam: 76666 42845 Resume + Qualification Documents + Aadhar Card + Pan Card + 4 passport size photo + Wear shoes Total 200 posts Male & female both applicable

Flash Viven Machining Technologies Pvt Ltd FREE JOB! FREE JOB Company Name- Flash Viven Machining Pvt Ltd Job Location - Mahalunge Chakan Pune Qualifications ITI Turner ,Machinist ,Fitter, Grinder CNC VMC : 15,000/-to 16000/_ Diploma All : 16,000/- Facility Canteen & Bus 8 / 12 Hours Duty JOB ROLL Production Opretor CNC / VMC / Machine Opretor / Contact Number: Hr Aasha Mam : 86248 17374 Hr Sapan Mam: 92265 62301 Hr Sakisha Mam: 76666 42845 Resume + Qualification Documents + Aadhar Card + Pan Card + 4 passport size photo + Wear shoes Total 200 posts Male & female both applicable

Flash Viven Machining Technologies Pvt Ltd FREE JOB! FREE JOB Company Name- Flash Viven Machining Pvt Ltd Job Location - Mahalunge Chakan Pune Qualifications ITI Turner ,Machinist ,Fitter, Grinder CNC VMC : 15,000/-to 16000/_ Diploma All : 16,000/- Facility Canteen & Bus 8 / 12 Hours Duty JOB ROLL Production Opretor CNC / VMC / Machine Opretor / Contact Number: Hr Aasha Mam : 86248 17374 Hr Sapan Mam: 92265 62301 Hr Sakisha Mam: 76666 42845 Resume + Qualification Documents + Aadhar Card + Pan Card + 4 passport size photo + Wear shoes Total 200 posts Male & female both applicable

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Analyst Qualifications: Master of Pharmacy Years of Experience: 3 to 5 years Language - Ability: English - Expert 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 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 affairs tasks of building regulatory dossiers 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.You will be expected to collect, collate and evaluate the scientific data gathered as part of R & D. Advise on legal and scientific restraints and requirements. Ensure the organization`s products comply with current regulations. Example; Build regulatory submission strategy, author CMC documents, and health authority packages etc. What are we looking for? Life Sciences Regulatory Services Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Agility for quick learning 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 Qualifications Master of Pharmacy

This position is responsible for effective operational and regulatory support to Sandoz as well as to regional/global organizations for assigned regulatory submission and maintenance activities, including preparation and submission of regulatory dossiers, maintenance of regulatory databases and archives and artwork-related activities. Job Description Your Key Responsibilities: Your responsibilities include, but not limited to: Is responsible for implementing regulatory strategy and managing operational activities for assigned medium regions. Provides input into global regulatory strategy and contributes to Regulatory Functional Plan (RFP) and Seed Document, or their equivalents, including identification of gaps or risks in global strategic plan for assigned regions. Partners with regions to align on regulatory strategy in order to fulfil business objectives. Implements RFP across assigned regions. 1/3. Determines requirements and sets objectives for Health Authority (HA) interactions with DRA GPT representative and/or GTAL. Facilitates preparation and finalization of briefing books and contributes to preparation of summary documents. Develops and implements plans for timely response to HA requests and coordinates responses. May serve as local HA liaison depending on location (e.g., FDA or EMA). Drives coordination, planning, and submission of dossiers in assigned regions worldwide. Review of global dossier summary documents. Develops and implements plans to avoid/minimize clock stops during submission review. Reviews, approves and submits Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs). Reviews and submits Risk Management Plans. May lead negotiations for regional approvals independently or with DRA GPT representative and/or GTAL. Responsible for facilitating timely submission and approval of dossier with HAs under the guidance of the DRA GPT representative and/or GTAL. Erroneous decisions result in critical delays and modifications to projects or operations; cause substantial expenditure of additional time, human resources, and funds; and jeopardize future business activity. Contributes to and often leads the development of departmental goals and objectives. What you ll bring to the role: Essential Requirements: Minimum 5+ years of experience in Regulatory Affairs 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 Sandoz 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.

Eugia Pharma is looking for Regulatory Affairs Associates with good experience in US and Canada Market. Job Location : Pashamylaram, Hyderabad Canteen and Transportation facility available JD for US Market Panning, reviewing and submission for assigned ANDA and NDA projects. Excellent drafting skills for FDA Deficiencies with high quality and regulatory standards in response. Evaluation and good interpretation of post approval changes. Submission of Supplements like CBE, CBE-30 and Prior Approval Supplement (PAS), Annual Reports. Review and authorizing regulatory change controls. Knowledge of eCTD, Module 2and 3. Formulate US Regulatory filing strategy for new projects. JD for Canada Market Experience in Dossier compilation (Injectable & OSD dosage forms) & knowledge of regulatory procedures and guidelines (ICH). Planning, execution and assessment of product life cycle management activities and strategies (LCM & Variation) Review technical documents like Protocols, API & Drug product technical packages, Change Controls etc and prepare technical documents to support regulatory submissions Knowledge in query response to agencys questions within assigned timelines

FREE JOB FREE JOB COMPANY - HANSA FLEX PVT LTD LOCATION - WASULI PHATA, CHAKAN PUNE QUALIFICATION - ITI - 18000/- (Turner, Machinist, Fitter, Grinder, CNC, VMC) DIPLOMA ALL - 18000/- BE/BTECH - 18000/- 8 HOURS DUTY CANTEEN & BUS 500 ATTENDANCE BONUS JOB ROLL PRODUCTION OPERATOR / CNC/ VMC / MACHINE OPERATOR Contact Us - HR SAPNA MAM - 9226514195 HR RUPALI MAM - 7741005871 TALENTCORP SOLUTIONS PVT LTD