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5.0 - 9.0 years
7 - 8 Lacs
Ahmedabad
Work from Office
Compile, prepare, review and submit ANDA submissions and Amendments to FDA with an overall objective to avoid major deficiencies and contribute to get approval within the shortest timeframes possible. Maintains full awareness of all regulatory activities on assigned projects and ensures that project deadlines and performance standards for these projects are established and met. Must have expertise/prior experience in Sterile (Injectables/Ophthalmic/Otic/IV Bags) dosage form ANDAs either with Aseptic sterilization or Terminal sterilization or both techniques. Ensure timely submission of all assigned projects. Review / prepare documents which meet the requirement set forth by US FDA and accepted for review by FDA without query or RTR. Evaluate change controls and formulates strategies for correct filing categories, with minimal involvement of supervisor. Proactively raises major issues if any to superior for resolution and agreement. Compile and submits critical post-approval supplements, such as CBE, CBE-30 and PAS. Work very closely with all relevant departments at the time of product initiations, R&D phase, ANDA/Bio Execution and after initiation of stability to ensure timely availability of all documents to ensure timely submissions. Prepare and finalize controlled correspondence as well as Pre-submission meeting package (Pre-ANDA, Pre-IND and Pre-NDA) to FDA on specific issues as needed for assigned projects. Assess the deficiency letter immediately after receipt from FDA, perform in-detail gap assessment and discuss with superiors to finalize the strategy to respond the deficiency. Proactively raises major project issues to superior for resolution and agreement. Be flexible in timings and available for t-cons as per US team schedule. Evaluate final compositions for IIG and Proportionality similar criteria s and develop regulatory strategies to avoid acceptable for filing issues. Review the API DMFs thoroughly and share the review comments to purchase department on-time. Follow up with purchase team or with DMF holder directly as needed to ensure compliance to provided comments on-time. Responsibilities: Ability to maintain a high level of accuracy and attention to detail, while meeting deadlines for assigned projects. Excellent written (Technical writing) and verbal communication skills and interpersonal skills. Prior experience working with ANDAs, INDs, NDAs and FDA correspondences. Time management, organization and planning skills, multi-tasking and prioritization skills in a fast-paced environment are required. Ability to communicate effectively and collaboratively as part of a team in a respectful manner. Ability to interface with professionals domestically and abroad. Ability to work independently, self-starter. Working knowledge of ICH, FDA and 21 CFR regulations. Should archive and maintain all submissions in a systematic way. Performs administrative functions as directed by Management to support projects and to ensure the smooth operation of the department. Maintain current knowledge of regulations and other issues that affect products and industry. Good problem solving skills and analytical ability. Strong computer skills in order to learn new programs as quickly as possible. Experience in MS Word, Excel, Power-point, Outlook and Adobe Professional is a must. Skills: Required Skills: Regulatory Submission & Dossier Filing | Advanced Regulatory Guidelines Knowledge | Advanced Cross Functional Communication | Intermediate Change Management & Documentation | Intermediate Problem Solving & Risk Mitigation | Intermediate Change Control & Regulatory Impact Assessment | Advanced Product Lifecycle Management | Advanced CMC Documentation | Advanced Health Authority Query Response | Advanced Regulatory Strategy Development | Advanced
Posted 4 days ago
0.0 - 3.0 years
3 - 6 Lacs
Gurugram
Work from Office
We are seeking a meticulous Legal Operations Intern to handle day-to-day legaloperations including NDA management, contract review, document abstraction, andredlining support for ongoing projects. Key Responsibilities Review, negotiate, and manage Non-Disclosure Agreements (NDAs) Perform contract abstraction and create executive summaries Provide redlining support for various legal documents and agreements Summarize complex legal documents for internal stakeholders Assist in contract lifecycle management Support ongoing projects with legal documentation review Maintain contract databases and tracking systems Coordinate with internal teams on legal requirements for projects Required Qualifications Currently pursuing LLB or LLM degree (2nd year onwards preferred) Strong contract review and negotiation skills Experience with redlining and document markup Excellent summarization and abstraction abilities Proficiency in legal document management systems Knowledge of commercial contracts and corporate law Attention to detail and ability to work under tight deadlines Proficiency in MS Office Suite and PDF editing tools
Posted 4 days ago
10.0 - 12.0 years
10 - 15 Lacs
Chennai
Work from Office
Responsibilities & Key Deliverables Liaison with Platform team and VES COE s for ensuring Program defined TCP are meeting the Targets L1 to L4 Timeplan preparation and monitoring. Ensure control of timeline revisions are updated and communicated to respective COE s Project Risk monitoring and escalation to GPH s/Delivery heads/Vertical Heads/President Gateway deliverables - Activities monitoring and closure, Critical path identification. Represent respective GPH s in NPQ meetings Software releases tracking in line with MPDS Gateway CMTCP monitoring Timeline and Performance Circulate Project MIS report to leadership team Maintain and publish project specific - single issue list and follow-up for closure Support for new Program scope finalization and Budget estimation Support for E-BOM release and build intent sign off for respective builds Support for Parts tracking for vehicle build requirement in co-ordination with CDMM Monitor supplier end development activities and escalate critical concerns Monitor and publish Validation, RGA, Plant specific concerns reports to internal team Investment and Material Cost to be monitored and communicate to central budget management team and escalate for deviation IMCR, Field concerns - consolidation and monitoring for implementation Monitor and manage resource utilization Standardization - within projects Support for NDA/PR-PO/Contract/ Service agreement preparation, IPR Registration and Approval tracking Knowledge Management & lessons learnt deployment Experience 10 to 12 years Industry Preferred Qualifications BE/B Tech Electrical Engineering BE/B Tech Electrical and Electronics Engineeing BE/B Tech Automobile engineering BE/B Tech Mechatronics Engineering General Requirements Very Good Vehicle system knowledge and E&E agregates in the vehicle- Distribution system, Starting & Charging system, Lighting system and swtichtes Expertise in WH & vehicle trouble shooting Knowledge in Catia V5, Capital Harness is added advantage Program management skills Basic level knowledge in Vehicle electronics & In Vehilce netwroking systems - Body contorl module, ABS/ESP, Airbag &Infotainment, Communicaiton protocols like CAN & LIN
Posted 5 days ago
7.0 - 12.0 years
8 - 13 Lacs
Chennai
Work from Office
Responsibilities & Key Deliverables Liaison with Platform team and VES COE s for ensuring Program defined TCP are meeting the Targets L1 to L4 Timeplan preparation and monitoring. Ensure control of timeline revisions are updated and communicated to respective COE s Project Risk monitoring and escalation to GPH s/Delivery heads/Vertical Heads/President Gateway deliverables - Activities monitoring and closure, Critical path identification. Represent respective GPH s in NPQ meetings Software releases tracking in line with MPDS Gateway CMTCP monitoring Timeline and Performance Circulate Project MIS report to leadership team Maintain and publish project specific - single issue list and follow-up for closure Support for new Program scope finalization and Budget estimation Support for E-BOM release and build intent sign off for respective builds Support for Parts tracking for vehicle build requirement in co-ordination with CDMM Monitor supplier end development activities and escalate critical concerns Monitor and publish Validation, RGA, Plant specific concerns reports to internal team Investment and Material Cost to be monitored and communicate to central budget management team and escalate for deviation IMCR, Field concerns - consolidation and monitoring for implementation Monitor and manage resource utilization Standardization - within projects Support for NDA/PR-PO/Contract/ Service agreement preparation, IPR Registration and Approval tracking Knowledge Management & lessons learnt deployment ngs Experience 7 to 12 years Competencies Very Good Vehicle system knowledge and E&E agregates in the vehicle- Distribution system, Starting & Charging system, Lighting system and swtichtes Expertise in WH & vehicle trouble shooting Knowledge in Catia V5, Capital Harness is added advantage Program management skills Basic level knowledge in Vehicle electronics & In Vehilce netwroking systems - Body contorl module, ABS/ESP, Airbag &Infotainment, Communicaiton protocols like CAN & LIN Qualifications BE/B Tech Electrical Engineering BE/B Tech Electrical and Electronics Engineeing BE/B Tech Automobile engineering BE/B Tech Mechatronics Engineering General Requirements
Posted 5 days ago
0.0 - 3.0 years
0 - 1 Lacs
Vadodara
Work from Office
Generate leads via LinkedIn, Upwork & emails. Pitch IT services, convert leads, understand client needs, coordinate proposals. update CRM Build long-term client ties, and meet monthly/quarterly sales targets. Flexi working Work from home Sales incentives Performance bonus
Posted 5 days ago
8.0 - 10.0 years
25 - 30 Lacs
Chennai
Work from Office
Overview STAMPING COMMODITY BUYER Responsibilities Job Summary: The Commodity Buyer will be responsible for the strategy and execution of his/her commodity to meet corporate goals in supply base management, cost reduction, supplier reduction, and quality improvement and part consolidation. One of the primary responsibilities of this position is to develop and implement cost reduction opportunities and building a strategic supply base. Strong emphasis will be on meeting metrics, implementing cost reduction strategies while coordinating business relationships and agreements with major suppliers. The Commodity Buyer will create the supply base strategy and coordinate efforts with the program buyer to ensure supply base strategy is being followed. In general, the Commodity buyer will manage his/her commodities from 90 days after SOP through end of life while also managing the overall supply base strategy in addition to the responsibilities listed above. This position will report to the purchasing manager. Duties and Responsibilities: Executes negotiation of commodities; works independently with minimal supervision, exercising discretion, judgment, and professionalism in all tasks. Develop and maintain relationships with suppliers through regular communication, performance reviews, onsite visits. Lead and resolve commercial issues with the supply base. Work proactively to solicit ongoing coordination and cooperation in driving cost down, while managing commodity deck P&L. Helps to manage supplier score cards. Maintains supplier purchase orders and NDA(Non Disclosure Agreement). Close coordination with various departments and Department Managers and Supervisors as required. Understands Supplier Market situation and forecasts the impact to the supply chain. Ensures prompt conflict resolution between vendors and the Company, working with the team both internally and externally. Mandates year over year supplier savings and business link for any business new awarded. Ensures NDA / contracts with the suppliers towards protect company interests. Participates in continuous improvement activities that may include developing program to improve supplier performance. Qualifications Education & Experience: Education: Bachelors degree in Engineering, supply chain, or related field or applicable industry experience to substitute. Skilled in negotiations, supplier selection and the development, approval and control of purchases in a decentralized environment. Strategic purchasing experience as it relates to supplier relations, sourcing and contract management. Essential skills Qualifications: five plus years automotive commodity purchasing experience. Proven negotiation skills, with implemented cost savings. Work location: Chennai. Working knowledge/experience in machining, stamping, or casting is a plus. SAP knowledge a plus. Excellent verbal and written communications skills. Ability to handle multiple projects simultaneously. Self-driven, positive can-do mentality. Seizes opportunities and is not fearful of jumping into challenging situations. Deals with ambiguity and can shift gears comfortably, easily able to cope with change. Customer focused. Ability to make decisions in a timely manner, sometimes without complete information or under tight deadlines. Key Words: BIW, Stamping, Steel raw material, Steel & Stamping Commodity Experience 8 to 10 YearsIn OEM and Tier 1 Automotive
Posted 1 week ago
8.0 - 10.0 years
25 - 30 Lacs
Chennai
Work from Office
Overview COMMODITY BUYER - Injection Moulding Parts Responsibilities Job Summary: The Commodity Buyer will be responsible for the strategy and execution of his/her commodity to meet corporate goals in supply base management, cost reduction, supplier reduction, and quality improvement and part consolidation. One of the primary responsibilities of this position is to develop and implement cost reduction opportunities and building a strategic supply base. Strong emphasis will be on meeting metrics, implementing cost reduction strategies while coordinating business relationships and agreements with major suppliers. The Commodity Buyer will create the supply base strategy and coordinate efforts with the program buyer to ensure supply base strategy is being followed. In general, the Commodity buyer will manage his/her commodities from 90 days after SOP through end of life while also managing the overall supply base strategy in addition to the responsibilities listed above. This position will report to the purchasing manager. Duties and Responsibilities: Executes negotiation of commodities; works independently with minimal supervision, exercising discretion, judgment, and professionalism in all tasks. Develop and maintain relationships with suppliers through regular communication, performance reviews, onsite visits. Lead and resolve commercial issues with the supply base. Work proactively to solicit ongoing coordination and cooperation in driving cost down, while managing commodity deck P&L. Helps to manage supplier score cards. Maintains supplier purchase orders and NDA(Non Disclosure Agreement). Close coordination with various departments and Department Managers and Supervisors as required. Understands Supplier Market situation and forecasts the impact to the supply chain. Ensures prompt conflict resolution between vendors and the Company, working with the team both internally and externally. Mandates year over year supplier savings and business link for any business new awarded. Ensures NDA / contracts with the suppliers towards protect company interests. Participates in continuous improvement activities that may include developing program to improve supplier performance. Qualifications Education & Experience: Education: Bachelors degree in Engineering, supply chain, or related field or applicable industry experience to substitute. Skilled in negotiations, supplier selection and the development, approval and control of purchases in a decentralized environment. Strategic purchasing experience as it relates to supplier relations, sourcing and contract management. Essential skills Qualifications: five plus years automotive commodity purchasing experience. Proven negotiation skills, with implemented cost savings. Work location: Chennai. Working knowledge/experience in machining, stamping, or casting is a plus. SAP knowledge a plus. Excellent verbal and written communications skills. Ability to handle multiple projects simultaneously. Self-driven, positive can-do mentality. Seizes opportunities and is not fearful of jumping into challenging situations. Deals with ambiguity and can shift gears comfortably, easily able to cope with change. Customer focused. Ability to make decisions in a timely manner, sometimes without complete information or under tight deadlines. Key Words: Exposure to Injection moulding parts ( FBP/PBP), Bumper, Spoiler, Roof Rail, Exterior Claddings, Mud Guard, Cowl Grills, ABC Pillars, Chrome/Painted Parts Experience 8 to 10 YearsIn OEM and Tier 1 Automotive
Posted 1 week ago
8.0 - 13.0 years
9 - 15 Lacs
Nashik, Pune, Aurangabad
Work from Office
Position: Assistant Manager / Deputy Manager - Marketing Experience - 6 To 8 Years Contact - 9356395439 Email - punejob2025@gmail.com Preferred Industry - Plastic Injection Molding, From Automobile Industry only. Profile JD: 1. RFQ Generation & Handling. 2. Costing 3. Develop new market & new customers where business is not present. 4. Knowledge of Thermoplastics , Inj Molding, Painting & Plating 5. Prepare and monitor the marketing budget on a quarterly and annual basis 6. Measure and report on the performance of marketing campaigns, gain insight and assess against goals 7. Analyses consumer behavior and adjust email and advertising campaigns accordingly 8. NDA review and updates, Business Purchase Agreement Renewals 9. RM Price Amendment 10. Payment Follow-ups & Customer Visits 11. Monthly MIS reports (Sales/Marketing/Automotive Trend) 12. New Project Co-ordination with NPD Team 13. Customer satisfaction & ensure QCDDM 14. Internal Audit (IATF)
Posted 1 week ago
2.0 - 7.0 years
6 - 10 Lacs
Greater Noida
Work from Office
Working Days - Monday to Saturday Location: Greater Noida (Pari Chowk) Client : Chemical Manufacturing & Energy Transition Must have experience in Corporate Law Side.b Key Responsibilities: 1. Draft, review, and vet various legal documents, including but not limited to: Service Agreements, Vendor Agreements, NDAs, MOUs, Employment Contracts, Lease Deeds, etc. 2. Assist in negotiation and finalization of commercial contracts with vendors, clients, and service providers. 3. Coordinate with internal teams (HR, Sales, Procurement, etc.) to understand business needs and ensure legal compliance in all documentation. 4. Provide day-to-day legal advisory to the management on corporate and operational matters. 5. Conduct basic legal research on applicable laws, rules, and regulations. 6. Maintain records of all executed contracts and track renewal or expiry timelines. 7. Assist the external legal counsel as and when required. 8. Assist in handling notices, replies, and regulatory correspondences. 9. Ensure adherence to applicable laws, rules, and corporate policies. Qualifications & Skills: - Bachelors degree in Law (LL.B) from a recognized university. - 2-5 years of experience in corporate legal function or legal consultancy, with focus on contract law and drafting. - Strong knowledge of Indian Contract Act and commercial laws. - Excellent drafting, communication, and analytical skills. - Ability to multitask, prioritize work, and handle matters independently.
Posted 1 week ago
5.0 - 10.0 years
7 - 12 Lacs
Gurugram
Work from Office
Designation: Assistant Manager, Company Secretary Location: Gurugram, Haryana Schedule: 45 hours per week Onsite- Hybrid 4 Days work from office Intro : The Assistant Manager supervises the daily operations of the group and ensures that all the communications with clients are supported by emails, outlining agreed action steps, responsibilities, and deadlines. They are also involved in the preparation of budgets and forecasts for the group and comparing these with the previous budgets and forecasts. Our team is dedicated to creating long-term relationships with our clients and business partners, and we strive to provide a personalized and practical approach to our services. We take pride in our industry-leading services and are committed to helping our clients stay compliant with national and international legislation. Does this sound like a team you want to be a part of Additionally, we provide training, mentorship, and opportunities for growth. If you re ready to take on a challenge and make an impact, CSC is the place for you. What you ll do for us Experience in handling a portfolio of clients across diverse industries Develop an in-depth knowledge of existing and potential clients, their industry, and key contacts Meet prospective clients and prepare fee proposals, including follow-through until the job is accepted or rejected Responsible for filing and registering any document including forms, returns, and applications which may include drafting of letters and resolutions Advise the clients on the secretarial matters as and when required Handles the promotion, formation, and incorporation of companies and the related matters as when required by the client companies Manages all the tasks related to securities and their transfer and transmission Drafting and reviewing the Contracts as per the need of the business Manage and coordinate the Legal or Compliance Audit activities for the clients Completing all the legal compliances Handling all kind of secretarial documents of clients and keeping the tracker and record of the same for future purposes Keeping up to date with any regulatory or statutory changes and policies that might affect the clients organization Review of NDA, engagement letters, business contracts, MoU, financing agreement, service contracts, etc. for the clients Managing a small team as well Perform high-level review on staff s deliverables and add value to the work that has to be delivered to the clients Focus on providing good client service ensuring that clients receive prompt responses to requests and queries Ensure all communications with clients are supported by emails, outlining agreed action steps, responsibilities, and deadlines Responsible for ensuring that commitments made to the client are followed-up in a timely manner so that the clients are satisfied What technical skills, experience, and qualifications do you need Required Qualifications: Excellent verbal and written communication skills Moderate knowledge of Companies Act, Contract Act, Industrial Disputes Act, Insolvency Code, Stamp Act, Registration Act, etc. Ability to research on the matters as per the business Excellent analytical skills to analyze and opine on various statutory provisions Excellent client servicing skills and strong problem-solving skills Able to work independently and work under tight deadlines Able to train, lead and motivate a team of professional staff Meticulous, organized, detailed and deadline-oriented Preferred Qualifications: Qualified CS or Law Graduate is preferred Minimum 5 years of exposure in professional firms providing corporate secretarial services Why work with us At Intertrust Group, a CSC company, we re always looking ahead, finding ways to improve and anticipate the future needs of our clients. Curiosity fuels our innovation and productivity drives our results. This proactive mindset has helped us adapt and create solutions that have enabled businesses to run smoother and smarter for more than 120 years. CSC is committed to attracting, developing, and retaining talented people whose personal values align with ours. We empower our colleagues to bring the right solutions to market to meet client demand. That s why we re the premier provider of global solutions for more than 180,000 businesses. CSC is a great place to work with smart and dedicated people. We ve been voted a Top Workplace every year since 2006 and are a National Top Workplace in the U.S. for the second consecutive year and Best Place to Work in India.. We offer challenging work and career opportunities. Most positions are filled with internal moves and colleague referrals. Colleagues are eligible for an annual success sharing bonus or commission plans based on role and individual performance. Our global standard for our work environments supports current and future technology initiatives through open design, sit-stand workstations, and digital interface points with wireless access throughout the campus. It s an exciting time for us in terms of growth and expansion. About Intertrust Group, a CSC company We are the premier global business, legal, and financial services company providing knowledge-based solutions to clients worldwide. Based in Wilmington, Delaware, U.S., we have locations and capabilities in more than 140 jurisdictions in the Americas, Europe, Asia Pacific, and the Middle East, with more than 8,000 employees. We are the business behind business. Working with us means entering a dynamic, international, and growth-oriented company. Diverse teams give us a competitive advantage and drive innovation. We re committed to attracting, developing, and retaining talented people who create an environment where everyone is valued and respected. CSC is an equal opportunity employer
Posted 1 week ago
8.0 - 10.0 years
25 - 35 Lacs
Noida
Work from Office
Job Title: Legal and Contract Manager Company: Hitachi Rail GTS India Noida, India. Salary: As per Industry Company Overview: Hitachi Rail is a leading partner to the world s best transportation companies, with a comprehensive portfolio of rail solutions and services for the urban, mainline and freight railway markets. Job Roles & Responsibilities: Legal and Contract Management support to Hitachi Rail GTS India: 80% Responsible for drafting, negotiating, preparing and managing commercial contracts (e. g. procurement and supplier contracts, service agreements, letters of intent, MOU, NDA, etc ) and company templates (Sales & Purchase T&Cs, ) to be executed from proposal to completion of projects, including partnerships and supply chain. Work closely with operational and compliance functions and help in elaborating relevant contractual solutions and identifying contractual, legal and compliance issues so that risks are detected, measured and mitigated. Ensure that contractual, commercial and technical risks (ability to understand technical and commercial aspects of contracts) to the business are minimized and the company s operating needs are met all along a project (from bid phase to contract performance). In compliance with the relevant Group policies, the incumbent will interface with external counsels and law firms for analysis and management of specific legal issues in the framework of complex contractual and/or legal arrangements. Provide legal guidance, advice and promote legal awareness. Manage resolution of disputes and litigation relying on local law firms. Corporate secretary, governance and board office: 10% Provide expertise in local legal and contractual systems related to Hitachi Rail GTS business activities in India. Draft, update, implement and monitor the governance rules and delegations of authority/signature in line with Hitachi Rail rules and local laws. Perform secretarial responsibilities for corporate bodies (Board(s), General Meeting(s) and Management Meetings including related preparation and documentation. Responsible for addressing corporate law, governance and compliance aspects for Hitachi Rail GTS India. Draft on behalf of shareholders the statutory resolutions required for the compliance of companies with local company laws/regulations. Secure the legal sustainability and continuity of Hitachi Rail GTS India, particularly to adapt to changes in laws, regulations and succession of management. Legal accreditations and documentation: 10% Manage, update, renew and archive legal and contractual documents. Monitor the timely updating and renewal of local administrative documents. Manage the legal qualification and local legal accreditations of Hitachi Rail GTS India to be qualified to perform business and commercial activities in compliance with local regulation Skills: Strong experience in drafting, reviewing, and negotiating commercial and procurement contracts. Good understanding of commercial law, public procurement law, and corporate legal frameworks. Excellent written and verbal communication skills. Ability to work both independently and as part of a team. Strong organizational and time management skills with the ability to prioritize tasks. Practical, solution-oriented, and business-focused approach to legal issues. Approachable, flexible, and able to handle multiple stakeholders. Knowledge of IT law (cybersecurity, data protection) will be an added advantage. Comfortable using legal and documentation tools; good IT skills appreciated Experience: 8 to 10 years experience in commercial and public procurement law in an international (technology) company or in a law firm and have been exposed to both domestic and international commercial contracts. Education: Bachelor s degree in law (LL. B) from a recognized university is mandatory. Master s degree in law (LL. M) with specialization in Commercial/Corporate Law will be an added advantage. Membership in Bar Council of India or any relevant State Bar Council preferred. Additional certifications in Contract Management, Corporate Governance, or Compliance would be beneficial.
Posted 1 week ago
2.0 - 5.0 years
4 - 7 Lacs
Ahmedabad
Work from Office
3109 Legal Advisor - Intech 3109 Legal Advisor Prepare, amend and evaluate Legal documents like NDA, MSA, AGM MSA and other (Contracts of Associates, Clients and frontend partner) Advise company/MD/CXO s for legal matters Legal Support for long outstanding payments Responding to all legal queries Streamlining legal processes Advising on legal aspects of IPO Protecting the Intellectual Property Rights Monthly meetings with concerned departments Management of relevant records in office Establishing and ensuring a listening and culture of legal department in organisation. Foreseeing the challenges and preparing a legalpreparing legal framework to protect company. On request, participating and leading any and all legal conversation with all stakeholders as and when needed. Leading and dealing with legal escalation of grievances within the company or outside of company.
Posted 1 week ago
15.0 - 20.0 years
20 - 35 Lacs
Vadodara
Work from Office
Role & responsibilities 1. Characterization of RLD pack samples. 2. Finalization of packing configuration for Exhibit batch packing of new generic product/NDA as per requirement. 3. Identification of new packaging material & new vendor development for packaging materials. 4. Mold development for primary packaging material & secondary packaging material & its validation. 5. Support to Regulatory team on ANDAs/NDA’s filling for regulated market. 6. Coordination with NPI & planning team for launch of ANDA’s/NDA’s. 7.Preparation & revision of packaging material specification. 8. Preparation & review of MPC, FMEA, TA, DHF & AFMEA. 9. Preparation & review of Development Study protocol & report & execute the study. 10. Performing functional test as per regulatory requirement. 11. Coordination with Cross functional team like (FDD/RA/Plant/Marketing/PMO) for completion of task. 12. Participating in FAT of machines. 13. Support to plant for validation, trouble shooting and market complaints. 14. SOP preparation, periodic review and packaging lab equipment handling/maintain calibration records. 15. Preparation of Packaging documentation (Pack Style, Justification Report etc. as per Product/Regulatory) as required. 16.Handling of primary and secondary packaging material in storage area & maintaining the PM quantity for stability packaging at R&D.
Posted 1 week ago
2.0 - 5.0 years
20 - 25 Lacs
Hyderabad
Work from Office
Summary ~Novartis i m terilerine (CPOlar ve B lgesel pazarlama ve sat ekipleri) e itli d k-orta karma kl ktaki analitik raporlar konusunda analitik destek sa lamak. ~Niteliksel ve niceliksel analitikler sa layarak ve ileterek Novartis i m terileri i in veriye dayal karar vermeyi desteklemek ve kolayla t rmak ~Bilgi payla m , i e al m ve e itim deste i, i le ilgili t m g revlerde/faaliyetlerde destek ekibi lideri, s re dok mantasyonu ve bilgi havuzlar olu turma gibi e itli giri imlere dahil olarak uygulama olu turmada GBS ~ GCO i ini destekleyin. ~ Promosyon pazarlama materyallerinin tasarlanmas ndan sorumlu kapsaml bir tasar m ekibinin ayr lmaz bir par as olmak. About the Role Major Accountabilities ~ Mutab k kal nan SLAlara g re m teri gereksinimlerinin alt nda olu turun ve sunun. ~ Hizmetlerin teslimat boyunca uygun dok mantasyon ve ileti im ile yap land r lm proje y netimi yakla m yoluyla hizmet teslim etmek ~ Kalite g vencesi ; Kalite ve do ruluk i in kt lar n en y ksek d zeyde oldu undan emin olun. ng r len s reler i inde zaman nda proje teslimi. ~ Standart i letim prosed rlerinin (SOPler) olu turulmas ve s rd r lmesinde destek ~ Niteliksel ve niceliksel raporlar yakalayan bilgi havuzlar n n geli tirilmesi ve s rd r lmesinde destek. ~ e itli bilgi payla m oturumlar na kat lmak Key Performance Indicators ~Novartis i m terilerine (CPOlar ve B lgesel pazarlama ve sat ekipleri) e itli d k-orta karma kl ktaki analitik raporlar konusunda analitik destek sa lamak. ~Niteliksel ve niceliksel analitikler sa layarak ve ileterek Novartis i m terileri i in veriye dayal karar vermeyi desteklemek ve kolayla t rmak ~Bilgi payla m , i e al m ve e itim deste i, i le ilgili t m g revlerde/faaliyetlerde destek ekibi lideri, s re dok mantasyonu ve bilgi havuzlar olu turma gibi e itli giri imlere dahil olarak uygulama olu turmada GBS ~ GCO i ini destekleyin. ~ Promosyon pazarlama materyallerinin tasarlanmas ndan sorumlu kapsaml bir tasar m ekibinin ayr lmaz bir par as olmak. Work Experience ~ la sekt r nde al ma deneyimi ~Proje Y netimi ~Operasyon Y netimi ve Uygulama Skills ~Reklam Kampanyalar ~Alteryx (Alternatif) ~Analitik D nme ~Marka Bilinirli i ~ A ~Merak ~Dijital Pazarlama ~E-posta pazarlama ~Pazarlama leti imi ~Pazarlama Planlar ~Pazarlama Stratejisi ~Medya Kampanyalar ~S re Dok mantasyonu ~Stratejik Pazarlama Language ngilizce Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together? https://www. novartis. com / about / strategy / people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: 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:
Posted 1 week ago
4.0 - 8.0 years
10 - 11 Lacs
Bengaluru
Work from Office
Responsible for project planning & implementation for respective PAx. Responsible for identifying & driving cost reduction projects. Support price negotiations, RFQ machines, should- costig & MCR current forecast / target business plan by providing the demand planning by supplier / PAx Responsible for request of quotations (RFQ) for RPP/VCP and preparation f supplier decisions including the necessary documentation in accordance with valid guidelines. Responsible for project related contracts & documents (NDA, N2580. . . . ) Responsible for the necessary information management and key performance indicator tracking for RPP projects for PAx. Gaining the respective technical commodity knowledge, supplier market and support internal customers & market developments. Purchasing responsibility & accountability for all purchasing projects in accordance with all valid RB, PT & AC specific guidelines.
Posted 1 week ago
5.0 - 8.0 years
7 - 10 Lacs
Bengaluru
Work from Office
Responsible for RPP/VCP (BPV or Project leader) project planning & implementation for respective PAx. Responsible for identifying & driving cost reduction projects. Support price negotiations, RFQ machines, should- costig & MCR current forecast / target business plan by providing the demand planning by supplier / PAx Responsible for request of quotations (RFQ) for RPP/VCP and preparation f supplier decisions including the necessary documentation in accordance with valid guidelines. Responsible for project related contracts & documents (NDA, N2580. . . . ) Responsible for the necessary information management and key performance indicator tracking for RPP projects for PAx. Gaining the respective technical commodity knowledge, supplier market and support internal customers & market developments. Purchasing responsibility & accountability for all purchasing projects in accordance with all valid RB, PT & AC specific guidelines.
Posted 2 weeks ago
5.0 - 17.0 years
7 - 19 Lacs
Chennai
Work from Office
Responsibilities & Key Deliverables Liaison with Platform team and VES COE s for ensuring Program defined TCP are meeting the Targets L1 to L4 Timeplan preparation and monitoring. Ensure control of timeline revisions are updated and communicated to respective COE s Project Risk monitoring and escalation to GPH s/Delivery heads/Vertical Heads/President Gateway deliverables - Activities monitoring and closure, Critical path identification. Represent respective GPH s in NPQ meetings Software releases tracking in line with MPDS Gateway CMTCP monitoring Timeline and Performance Circulate Project MIS report to leadership team Maintain and publish project specific - single issue list and follow-up for closure Support for new Program scope finalization and Budget estimation Support for E-BOM release and build intent sign off for respective builds Support for Parts tracking for vehicle build requirement in co-ordination with CDMM Monitor supplier end development activities and escalate critical concerns Monitor and publish Validation, RGA, Plant specific concerns reports to internal team Investment and Material Cost to be monitored and communicate to central budget management team and escalate for deviation IMCR, Field concerns - consolidation and monitoring for implementation Monitor and manage resource utilization Standardization - within projects Support for NDA/PR-PO/Contract/ Service agreement preparation, IPR Registration and Approval tracking Knowledge Management & lessons learnt deployment Experience 5-17 Years Industry Preferred Qualifications BE/B Tech Electrical Engineering BE/B Tech Electrical and Electronics Engineeing BE/B Tech Automobile engineering BE/B Tech Mechatronics Engineering General Requirements Very Good Vehicle system knowledge and E&E agregates in the vehicle- Distribution system,Starting & Charging system,Lighting system and swtichtes Expertise in WH & vehicle trouble shooting Knowledge in Catia V5, Capital Harness is added advantage Program management skills Basic level knowledge in Vehicle electronics & In Vehilce netwroking systems - Body contorl module, ABS/ESP,Airbag &Infotainment, Communicaiton protocols like CAN & LIN
Posted 2 weeks ago
3.0 - 8.0 years
8 - 10 Lacs
Gurugram
Work from Office
1. Drafting standard SOWs for clients 2 .Review agreements required by business teams . (i) Preparation of synopsis for client contracts (ii) Preparation of obligation matrix for client contracts (iv) Review of VRF, standard NDA and Agreement, Required Candidate profile 1) Law Graduate with minimum 4-6 years of work experience 2) Strong MS office skills 3) Strong written and verbal communication Share resume on the given mail id shubhi.agrawal@silverskills.com
Posted 2 weeks ago
5.0 - 10.0 years
7 - 10 Lacs
Bengaluru, Vadodara
Work from Office
Job Title: Procurement Specialist- Non-IT Job Location: Baroda Shift Timings: 7 P.M IST - 4 A.M IST https://www.linkedin.com/showcase/collaberagtc/ https://collabera.com/globaltalentcenter/ https://www.collabera.com/ https://www.youtube.com/@CollaberaGTC/videos https://instagram.com/collaberagtc?igshid=ZWQyN2ExYTkwZQ== Collabera, a leader in staffing Industry, is looking for Procurement Specialist- Non-IT . Our employees work in fast paced, high energy work environment driven by our unique work culture that embraces competitiveness, passion and work hard-play hard approach to the fullest. Our clientele comprises of many Fortunes 100/500 organisations across various industry domains. Job Description: We are looking for a Category/Procurement Specialist who will be responsible for supporting Indirect sourcing initiatives with respect to non IT related projects and helping to manage daily purchasing activities. The specialist ensures that purchases are made at the lowest cost and highest quality consistent with the needs of the internal stakeholder, and in alignment with company policies and procedures. Specific responsibilities include, but are not limited to: Ensure all purchases are made in accordance with company policies and procedures. Establish NDAs, purchase orders and contracts, as appropriate. Support renewal requests, budgetary pricing requests, contract inquiries and Statement of Work review requests. Maintain appropriate documentation and files for all purchases made and Monitors supplier performance. Support the improvement and upkeep of sourcing templates and other documentation used within Indirect Purchasing. Meets with business users/ managers to understand business priorities and translate them into procurement plans; comprehends the industry and the Marketplace. Identify cost saving opportunities using competitive bidding (RFx), negotiations, and drive service improvements. Collaborate with internal Teams (Legal, finance, IT) to mitigate risk during contract negotiations. Report on active projects and contribute to collaborative, cross-functional reports. Executes risk mitigation, business continuity, cost management, and operation strategies. Perform other duties as assigned. Level Based Competencies: Building Strategic Working Relationships Business Acumen Planning and Organization Strategic Decision Making Ability to Manage Multiple Projects Strong Communication Skills Technical Knowledge/Skills: Understanding of purchasing and sourcing concepts, practices, and procedures Negotiation skills Excellent computer skills Familiar with financial management and comfortable with performing analysis Ability to excel in a matrix management environment Supply Chain knowledge General Knowledge/Skills: Excellent verbal and written communication skills Excellent organizational and follow up skills with a strong attention to detail Ability to adapt to a changing environment Strong analytical and problem solving skills Excellent time management skills Familiar with project management and vendor management skills Strong teamwork and interpersonal skills Education/Experience: Bachelor's Degree in the field of supply chain, procurement, or business Minimum 5+ years of experience in procurement, corporate purchasing focus is helpful Experience in use of P2P systems helpful but not required Sounds like you? Let me know your thoughts or concerns and lets get the dice rolling! Looking forward to hearing from you!
Posted 2 weeks ago
5.0 - 17.0 years
10 - 14 Lacs
Chennai
Work from Office
Responsibilities & Key Deliverables Liaison with Platform team and VES COE s for ensuring Program defined TCP are meeting the Targets L1 to L4 Timeplan preparation and monitoring. Ensure control of timeline revisions are updated and communicated to respective COE s Project Risk monitoring and escalation to GPH s/Delivery heads/Vertical Heads/President Gateway deliverables - Activities monitoring and closure, Critical path identification. Represent respective GPH s in NPQ meetings Software releases tracking in line with MPDS Gateway CMTCP monitoring Timeline and Performance Circulate Project MIS report to leadership team Maintain and publish project specific - single issue list and follow-up for closure Support for new Program scope finalization and Budget estimation Support for E-BOM release and build intent sign off for respective builds Support for Parts tracking for vehicle build requirement in co-ordination with CDMM Monitor supplier end development activities and escalate critical concerns Monitor and publish Validation, RGA, Plant specific concerns reports to internal team Investment and Material Cost to be monitored and communicate to central budget management team and escalate for deviation IMCR, Field concerns - consolidation and monitoring for implementation Monitor and manage resource utilization Standardization - within projects Support for NDA/PR-PO/Contract/ Service agreement preparation, IPR Registration and Approval tracking Knowledge Management & lessons learnt deployment Experience 5 to 17 Years Industry Preferred Qualifications BE/B Tech Electrical Engineering BE/B Tech Electrical and Electronics Engineeing BE/B Tech Automobile engineering BE/B Tech Mechatronics Engineering General Requirements Very Good Vehicle system knowledge and E&E agregates in the vehicle- Distribution system,Starting & Charging system,Lighting system and swtichtes Expertise in WH & vehicle trouble shooting Knowledge in Catia V5, Capital Harness is added advantage Program management skills Basic level knowledge in Vehicle electronics & In Vehilce netwroking systems - Body contorl module, ABS/ESP,Airbag &Infotainment, Communicaiton protocols like CAN & LIN
Posted 2 weeks ago
6.0 - 9.0 years
4 - 5 Lacs
Navi Mumbai, Mumbai (All Areas)
Work from Office
Draft, review, and manage contracts. Ensure legal compliance and support negotiations. Ideal for legal pros with 6–8 yrs of experience. Internship in Nariman Point; permanent role in Ahura, Mumbai. Required Candidate profile Experienced legal professional (6–8 yrs) skilled in contract drafting, review, and negotiation. Strong legal compliance knowledge, attention to detail, and stakeholder coordination abilities.
Posted 2 weeks ago
2.0 - 7.0 years
3 - 6 Lacs
Bengaluru
Hybrid
Role & responsibilities SKILLS: CONTRACT MANAGEMENT Contract ManagementJob LevelExperience (in Years)Job Description 3A3+ years• Graduate, preferred - Bachelor in Law or similar qualification • Desired experience in end to end Contract Management and conducting related quality checks/analysis • Experience in reviewing and negotiating commercial terms and interpreting contractual language. • Standard Template Based - Drafting, negotiation, and execution of contracts between client and its 3rd party vendors meeting the Performance Standards • Draft low to mid complexity agreements of various types (e.g., Statements of Work, Master Professional Services Agreements, SOW Amendments, Donation Letters, Event Sponsorships, Art Services Agreements • Excellent legal analytical and review skills • Good written and verbal communication skills • Adept in using MS Office • Exposure to desired tools/legal databases Preferred candidate profile
Posted 2 weeks ago
6.0 - 11.0 years
5 - 8 Lacs
Ludhiana, Mohali
Work from Office
Responsibilities: Spearheading the management of the company's internal contract management tools Drafting of contracts (MSA, NDA, Legal Contracts, Service Agreements) for the client Negotiating commercial contracts with the clients (B2B clients only) Vetting of the contracts shared and proposed by the client for the services to be provided Maintain a roster for renewal of contracts and ensuring that contracts are renewed and active timely and all times Coordinating with finance team to understand impact of the rates and thus partnering with BD team to get better rates for the services Handle the overall contract management for a set of clients based out of the office. Candidate must have: Graduation in LLB. Minimum 5 years of relevant experience in Corporate contract drafting, vetting and reviewing. Minimum 3 years of relevant experience in Negotiations of rates. Minimum 3 years of experience in client communication and client meetings. Excellent Contract Drafting, reviewing, vetting and Negotiation skills. Amicable Personality to lead Contract Management and handle independent conversations with Client companies across India. You are a detail-oriented person and follow a stringent timeline with regards to the delivery of your contracts.
Posted 2 weeks ago
4.0 - 9.0 years
2 - 6 Lacs
Bengaluru
Work from Office
At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. Job Overview TE Connectivity's Contract Management Teams administer, extend, negotiate and terminate standard and nonstandard contracts. They conduct all aspects of proposal preparations, contract negotiations, contract administration, and supplier or customer contact activities to provide for proper contract acquisition and fulfillment in accordance with the company policies, legal requirements and supplier or customer specifications. Our Contract Management Teams are also responsible for partnering with the business to align our contract commitments, modifications and revisions. Job Responsibilities: Drafting and reviewing non-disclosure agreements (NDAs) and other types of commercial contracts (as and when required). This includes drafting fresh NDAs using playbook and templates provided, redlining NDAs received from vendors and customers and finalizing the same after obtaining inputs and feedbacks from the relevant stakeholders (wherever required), within the agreed turn-around-time. Collaborate and follow up with the relevant India and global teams to close the contractual requirements. Responsible for administration and internal filing of contracts on the relevant portal of the company in a diligent and timely manner. Maintain all contract documentation and ensure that files are maintained in a logical and sound sequence. Desired Candidate Profile: LLB (Enrolled with any State Bar Council) 4+ Years of experience High level of professionalism and ability to be a team player. Ability to independently manage communication with internal stakeholders and clients (whenever required). Excellent attention to detail and analytical skillset. Time management skills and ability to multi-task, prioritize and work in a fast-paced environment with minimal to no supervision. Ability to work with playbooks and contract templates. Interest to learn business aspects pertaining to the company Competencies ABOUT TE CONNECTIVITY TE Connectivity is a global industrial technology leader creating a safer, sustainable, productive, and connected future. Our broad range of connectivity and sensor solutions enable the distribution of power, signal and data to advance next-generation transportation, renewable energy, automated factories, data centers, medical technology and more. With more than 85,000 employees, including 8,000 engineers, working alongside customers in approximately 140 countries. TE ensures that EVERY CONNECTION COUNTS. Learn more atwww.te.com and onLinkedIn , Facebook , WeChat, Instagram and X (formerly Twitter). WHAT TE CONNECTIVITY OFFERS: We are pleased to offer you an exciting total package that can also be flexibly adapted to changing life situations - the well-being of our employees is our top priority! Competitive Salary Package Performance-Based Bonus Plans Health and Wellness Incentives Employee Stock Purchase Program Community Outreach Programs / Charity Events Across our global sites and business units, we put together packages of benefits that are either supported by TE itself or provided by external service providers. In principle, the benefits offered can vary from site to site.
Posted 2 weeks ago
1.0 - 6.0 years
0 - 1 Lacs
Bengaluru
Work from Office
Job description Should be able to Handle Secretarial Compliances independently, well versed with the Companies Act, 2013, Secretarial Standards along with the latest amendments and have thorough and technical knowledge of all type company compliances, rules and regulations. Preparing of agenda and papers for Board meetings, Committees, General meeting and oversee follow up action post Board meetings. Maintain corporate records and statutory registers. Vetting and scrutinizing of various kinds of contracts, including customer agreements, vendor contracts, NDAs, licensing agreements, partnership agreements. coordinate internal and external audits, ensuring compliance with all regulatory and statutory requirements.
Posted 2 weeks ago
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