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1.0 - 5.0 years
7 - 10 Lacs
Hyderabad, Switzerland, Germany
Work from Office
If your location allows for pay/benefit transparency, please click the link below to request further information on this position. Pay Transparency Request Form PURPOSE AND SCOPE: Assists in the support of the daily operational activities within Regulatory Operations for the preparation of regulatory submissions required to market new or existing licensed pharmaceuticals products in the domestic and international markets as assigned. Maintains systems designed to ensure compliance with electronic submission requirements and document management systems. In addition to publishing responsibilities, this role will lead and support the creation, implementation, and ongoing maintenance of departmental Standard Operating Procedures (SOPs), Work Instructions (WIs), and operational processes, ensuring alignment with evolving regulatory requirements, internal standards, and best practices. . PRINCIPAL DUTIES AND RESPONSIBILITIES: Serves as a seasoned regulatory operations professional with a comprehensive understanding of global submission requirements and processes; applies creative problem-solving to resolve a wide range of technical and operational issues. Manages the end-to-end preparation, compilation, publishing, quality control, validation, and delivery of electronic regulatory submissions (eCTD) in compliance with global Health Authority requirements and internal standards. Supports submission planning and execution for initial marketing applications and post-approval lifecycle submissions (e.g., supplements, variations, renewals) across multiple regions including the U.S., Canada, EU, and Asia-Pacific. Performs thorough QC reviews to ensure submission-ready documents meet formatting, technical, and regulatory standards. Collaborates cross-functionally with Regulatory Affairs, CMC, Medical Writing, Quality, and other stakeholders to ensure timely and accurate handoff of components for inclusion in submissions. Interprets and applies key regulatory guidance, regional submission specifications, and evolving eCTD requirements (including ICH, FDA, EMA, etc.). Leads and contributes to the development, revision, implementation, and training of departmental SOPs, WIs, and standardized publishing processes to ensure consistency, efficiency, and regulatory compliance. Assists in the management and continuous improvement of templates, procedures, and tools used to support global submission activities. Troubleshoots technical issues related to publishing tools and document formatting, particularly within MS Word and Adobe Acrobat, and supports resolution of validation errors. Participates in evaluating and implementing new regulatory technologies; ensures alignment with infrastructure standards and supports transitions from legacy systems to electronic platforms. Maintains compliant archival and storage of regulatory documents, ensuring alignment with regulatory and business needs. May mentor junior staff, provide publishing guidance, and act as a resource for complex submissions. Demonstrates strong organizational and time management skills with the ability to manage multiple priorities under tight deadlines. Ensures compliance with all applicable regulations, company policies, and the Code of Business Conduct. May escalate complex issues for resolution and assist with additional projects or duties as assigned. Assist with various projects as assigned by a direct supervisor. Other duties as assigned. Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions. PHYSICAL DEMANDS AND WORKING CONDITIONS : The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function EXPERIENCE AND REQUIRED SKILLS : Bachelor s Degree required; Advanced Degree desirable Minimum five (5) years of regulatory operations experience in the pharmaceutical or biotechnology industry, with a strong emphasis on global regulatory submissions. Proven expertise in the preparation, compilation, publishing, and validation of eCTD submissions in support of U.S. (FDA), Canada (Health Canada), EU (EMA, MHRA), and Asia-Pacific (PMDA, TGA, NMPA, etc.) regulatory requirements. In-depth knowledge of electronic publishing tools and Regulatory Information Management (RIM) systems. Proficiency with electronic document management systems (EDMS) and advanced knowledge of document formatting tools, particularly MS Word (template and style management) and Adobe Acrobat (PDF optimization and troubleshooting). Strong understanding of global regulatory submission guidance. Demonstrated experience managing multiple submission projects in parallel, with proven ability to meet tight deadlines and deliver high-quality, technically compliant outputs. Strong organizational skills and meticulous attention to detail; able to identify and resolve issues independently and proactively. Excellent written and verbal communication skills, with the ability to clearly document processes, communicate submission requirements, and collaborate effectively across teams. Experience with electronic submissions, specifically eCTD, required. Strong understanding of document management processes in a regulated pharmaceutical environment. Demonstrated understanding of the drug development process and project management experience is highly preferred. Proven experience in developing, revising, and maintaining departmental Standard Operating Procedures (SOPs), Work Instructions (WIs), and internal processes, with a focus on continuous improvement and regulatory compliance. Strong software troubleshooting skills. EOE, disability/veterans
Posted 3 days ago
5.0 - 10.0 years
55 - 60 Lacs
, Switzerland
On-site
Company : Saipem Work Location: Worldwide Vessel: Various Hook Up Vessels MISSION Organise, coordinate and control the execution of the Hook-up activities, both performed by subcontractors or in direct hiring, ensuring a proper coordination between disciplines supervisors and Hook-up engineering, overseeing the availability of project materials, equipment and tools, verifying that works are carried out in accordance with project documentation, schedule, safety and quality standards and procedures Represent Hook-up construction in daily meetings with Client TASKS Ensure that Hook-up activities are carried out as per time schedule and adhering to the time frame allocated to the specific work tasks Interface with Hook-up Planning and Control Analyst to share information regarding the pro gress of the work, highlighting possible cause of deviations between the program and the work carried out and to analyze the forecast for Client/Third parties inspections Interface with Hook-up Engineering to request instruction s to overcome possible problems/critical issues, propose alternative solutions and request preparation of technical queries Ensure the supervision and monitoring of the works performed, subcontracted or in direct hiring Coordinate Hook-up resources, indicating any needs or surplus In conjunction with commissioning superintendent, plan and monitor vendors or any specialists activities at site Manage the technical and administrative documentation Promote safe works practices and environmental protection, ensuring that safety standards are respected Ensure that an effective Permit to Work system is implemented and maintained for the safe execution of the activities supervised by discipline specialists Ensure the Hook-up Marine Spread management is performed according to hook-up execution needs, in a timely and effective manner At Yard: Cooperate with Hook-up team to give inputs and expertise into the preparation of project Job Card Ensure proper and time effective stocks of tools, equipment and consumables are arranged in line with project forecast workload Support Hook-up Manager into material management and carry over management during weekly meetings with fabrication department Provide inputs to the definition of the Hook-up works detailed planning REQUIREMENTS Minimum 8 Years of experience in Offshore Construction as Hook Up Superintendent
Posted 1 week ago
120.0 years
0 Lacs
Zug, Switzerland
Remote
Job Description TreuhänderIn mit eidg. Fachausweis/ Senior Accountant (80-100%) Zug, Switzerland Monday – Friday, 40 hours per week Hybrid Werden Sie Teil unseres dynamischen Teams bei CSC Schweiz als TreuhänderIn an unserem Standort in Zug, wo Sie eine entscheidende Rolle in der Bereitstellung von Treuhanddienstleistungen für unsere Kunden übernehmen. Mit über 8.000 Mitarbeitenden weltweit und Expertise in 140 Rechtsgebieten ist CSC das business behind the business®. Sie haben die Möglichkeit, mit internationalen Kunden und Experten in den Bereichen Buchhaltung, Steuern und Lohnbuchhaltung zusammenzuarbeiten und Ihre Erfahrungen über die Schweizer Treuhandbranche hinaus zu erweitern. Wir bieten Flexibilität, Wachstumsmöglichkeiten und ein attraktives Vergütungspaket. Als Treuhänder/in arbeiten Sie unter der Aufsicht des Business Unit Managers - Finance, der in Zug ansässig ist. Der/die Treuhänder/in arbeitet eigenständig und unterstützt bei den finanziellen Angelegenheiten von Kundenunternehmen in der Schweiz. Der/die Treuhänder/in stellt in enger Zusammenarbeit mit qualifizierten Rechts- und Steuerberater sowie im Einklang mit den gesetzlichen und unternehmensinternen Richtlinien die termingerechte und optimale Finanzverwaltung der Kundenunternehmen sicher, stets unter Berücksichtigung der lokalen Gesetzgebung und der Erwartungen der Kunden. Aufgaben: Eigenständige Verwaltung der Finanzbuchhaltung für Kundenunternehmen in der Schweiz. Erstellung und Überprüfung von Jahresabschlüssen, Abwicklung von Steuern, Mehrwertsteuer und Löhnen für die Kunden. Verwaltung des Abschlussprozesses und Erstellung von Finanzberichten gemäss Schweizer Obligationenrecht. Erstellung von Reporting-Packages und Cashflow-Berechnungen nach Schweizer OR (IFRS & US GAAP); Enge Zusammenarbeit mit Rechts- und Steuerberater zur Sicherstellung der Einhaltung der lokalen Gesetzgebung und der Unternehmensrichtlinien. Unterstützung des Teams bei Projekten über Treuhand-Dienstleistungen hinaus, z. B. abteilungsübergreifende Projekte; Erstellung von konsolidierten Jahresabschlüssen und Abwicklung von Intercompany-Transaktionen / Abstimmungen; Coaching von Treuhand-SachbearbeiterInnen und Unterstützung bei deren Entwicklung innerhalb unseres wachsenden Teams und der Organisation; Erkennen von Entwicklungen innerhalb der Kundenstrukturen und Identifikation möglicher kommerzieller Chancen; Teilnahme an Gründungs-, Restrukturierungs- und Liquidationsprojekten. Ihr Profil: Berufliche Senior Treuhand-/Buchhaltungsqualifikation (eidg. Fachausweis oder gleichwertig). Nachgewiesene 4-7 Jahre Erfahrung in der Schweiz sowie Kenntnisse aller Aspekte der Jahresabschlüsse und des Abschlussprozesses. Fundierte Kenntnisse des Schweizer Obligationenrechts. Kenntnisse in IFRS & US GAAP. Fähigkeit, IFRS-basierte Jahresabschlüsse zu erstellen. Fliessend in Englisch und Deutsch (mündlich, schriftlich und Berichtserstellung); Französischkenntnisse sind ein Plus. Versiert im Umgang mit IT-Tools wie MS Office, Abacus, SAP, Viewpoint und Dr. Tax. Analytisch, proaktiv, organisiert und ein ausgeprägter Teamplayer. Lernfreudig und bereit, Aufgaben über die Stellenbeschreibung hinaus zu übernehmen / Hands-on-Persönlichkeit. Unser Angebot: Interessante und abwechslungsreiche Tätigkeit in einem motivierten Team; Attraktives Gehalts- und Vergütungspaket; Möglichkeit, interne Arbeitsprozesse abteilungsübergreifend mitzugestalten; Zusammenarbeit mit externen Experten in den Bereichen Buchhaltung/Steuern und Lohnbuchhaltung für unsere internationalen Kunden, mit einem Blick über die lokale Treuhandbranche hinaus; Verantwortung bei abteilungsübergreifenden Kundenaufgaben und Projekten; Möglichkeiten für interne und externe Weiterbildung; Innovative Arbeitszeitmodelle und flexible Arbeitszeiten, einschliesslich der Möglichkeit, im Homeoffice zu arbeiten; Mindestens 5 Wochen Urlaub (abhängig von Ausbildung & Seniorität); Überstundenvergütung (in Freizeit und/oder Bezahlung); Und vieles mehr. Suchen Sie eine Herausforderung, die sowohl berufliche Weiterentwicklung als auch Work-Life-Balance bietet? Bei CSC Schweiz unterstützen wir nicht nur Ihre berufliche Entwicklung, sondern legen auch Wert auf Flexibilität und Innovation in unseren Arbeitsmodellen. Haben wir Ihr Interesse geweckt? Zögern Sie nicht, sich bei uns zu bewerben! Bitte reichen Sie Ihre Bewerbung auf Englisch ein. #CSC #CSCCareers About Us CSC is a global business, legal, and financial services company based in Wilmington, Delaware, USA, providing knowledge-based solutions to clients worldwide. We have offices and capabilities in over 140 jurisdictions in the Americas, Europe, Asia Pacific, and the Middle East, and more than 8,000 colleagues. We are the business behind business.® Visit our careers site to learn more about CSC and our commitment to our clients, communities, and each other. CSC is committed to creating a feeling of belonging through a diverse and growth-oriented environment where everyone is valued. CSC colleagues have global career opportunities and excellent benefits, including annual success-sharing bonuses or commission plans based on individual performance. To learn more, visit cscglobal.com/service/careers . We offer a range of support to colleagues with disabilities, ensuring people have the necessary resources to thrive in their roles. We encourage candidates to work closely with our talent acquisition partners to convey their specific needs. Our commitment to accessibility reflects our broader dedication to diversity and belonging, CSC only accepts resumes from employment agencies that are part of our approved supplier program. Resumes submitted from other agencies either to talent acquisition, our hiring leaders, employees, or through any other mechanism other than our supplier process, will not be eligible to claim related fees and the submitted resumes will be considered property of CSC. We encourage candidates to apply directly to our website and not through third-party sources. Disclaimer: The information above describes the general nature and level of work performed by employees in this role. It is not intended to describe all duties, responsibilities, and qualifications. About The Team At CSC®, we’re always looking ahead, finding ways to improve and anticipate the future needs of our customers. 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 employees to bring the right solutions to market to meet customer demand. That is why we are 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 have been voted a Top Workplace every year since 2006. We offer challenging work and career opportunities. Most positions are filled with internal moves and employee referrals. Employees are eligible for success sharing, bonus, or commission plans based on role and individual performance. CSC offers a competitive and comprehensive benefits package as part of your Total Rewards that includes annual leave, tuition reimbursement, employee referral bonuses, and more. As business needs allow, CSC offers hybrid/remote work schedules in alignment with local regulations. Specific details for this position will be discussed during the interview process.
Posted 2 weeks ago
0.0 - 3.0 years
2 Lacs
New Delhi, Switzerland, Mandi
Work from Office
Key Job Responsibilities To ensure quality of business and operational e ciency through proper process adherence and facilitate smooth functioning of branches. Promote and maintain positive relations with all contacts, customers, and potential customers Achieve desired level of productivity to meet & contribute towards branch profitability targets. Promotes the products and services; consistently cross-sells and Up-sells products at every opportunity. Conduct promotional activities for marketing and drive referral programs for customer acquisition Responsible to handle day to day transactions and valuables. Maintain all data and records related to daily transactions Retain customers, by working towards achieving the higher purpose to transform the life of the common man by improving their financial well being Knowledge, Skills & Attributes Result Orientation Customer Service & Retention Focus Digital Mindset Relationship Building Process Knowledge/ Orientation Effective Time Management Cross Selling / Upselling Skills Business Development Communication Skills Proficiency in local language and English Role Requirements Educational Qualification Graduate Experience Freshers / 1 year experience in lending / financial services
Posted 2 weeks ago
0.0 - 3.0 years
3 Lacs
New Delhi, Switzerland, Mandi
Work from Office
Key Job Responsibilities To ensure quality of business and operational e ciency through proper process adherence and facilitate smooth functioning of branches. Promote and maintain positive relations with all contacts, customers, and potential customers Achieve desired level of productivity to meet & contribute towards branch profitability targets. Promotes the products and services; consistently cross-sells and Up-sells products at every opportunity. Conduct promotional activities for marketing and drive referral programs for customer acquisition Responsible to handle day to day transactions and valuables. Maintain all data and records related to daily transactions Retain customers, by working towards achieving the higher purpose to transform the life of the common man by improving their financial well being Knowledge, Skills & Attributes Result Orientation Customer Service & Retention Focus Digital Mindset Relationship Building Process Knowledge/ Orientation Effective Time Management Cross Selling / Upselling Skills Business Development Communication Skills Proficiency in local language and English Role Requirements Educational Qualification Graduate Experience Freshers / 1 year experience in lending / financial services
Posted 2 weeks ago
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