15 Compilation Jobs

Description. Sr Regulatory Associate (CMC). Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.. Discover what our 29,000 employees, across 110 countries already know:. WORK HERE MATTERS EVERYWHERE. Why Syneos Health. We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.. Primary. Job Responsibilities. Practical understanding of ICH guidelines, GMP requirements, and regional regulatory frameworks (e.g., FDA, EMA). Post approval variation experience is mandatory for EU market and Preapproval MAA dosier experience for ROW is preferred.. Strong experience in preparation, compilation, review and submission of high-quality CMC dossiers for variations, renewals, annual reports, RTQs.. Can support change control assessment and impact assessments for global markets.. Capable to execute day-to-day tasks according to client processes and SOPs for building high quality global CMC dossiers.. Assists in training and mentoring of team members depending upon project requirements. Preparation, review and finalization of quality compliance reports, liaising with site, QA/ QP’s, CRAs and Client CMC team.. Ability to liaise with cross-functional teams (Quality, Manufacturing, Analytical, etc.) to gather necessary technical data and ensure regulatory consistency for global submissions.. Timely sensitization /escalation within team to maintain compliance and adherence to timelines.. Secondary. Understands Regulatory requirements for Marketing Authorization dossier applications for ROW markets.. Optional experience for tracking/ submission of regulatory/CMC commitments and update the databases. Hands on experience of RIMS/VEEVA vault.. Excellent written and verbal communication skills. Open to working in Cross-Cultural/Virtual teams. Attends client meetings as needed with relevant inputs. Good communication skills clearly articulate through emails/ calls; provide accurate update on regulatory activities for assigned products in internal or Client meetings. Qualifications. Minimum 4 years of experience required in preparation, compilation, review and submission of high-quality CMC dossiers for variations with Master’s degree in pharmaceutical sciences (preferred) or Master’s degree in other life sciences.. Ability to work independently and manage multiple priorities in a fast-paced consulting environment.. Detail-oriented, strong organizational skills to manage multiple priorities in a deadline-driven environment. Experience with RIMS/Veeva Vault for submission management, document lifecycle tracking, and regulatory compliance. Get to know Syneos Health. Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.. http://www.syneoshealth.com. Additional Information. Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.. Show more Show less

Programming Languages: Experience in languages like C or C++, or Python, Scripting: Experienced in Shell Scripting, Kernel and Package Management: Skilled in kernel configuration and package updates, Security: Expertise in Secure Boot (spkg creation) and Security FIT image creation, Custom ISO Creation: Proficient in Debian Live Build for custom ISO creation, Linux Device Drivers: Knowledgeable in Linux device driver development, Porting and Toolchains: Experienced in porting and toolchain management, System Debugging and Optimization: Strong skills in system debugging and optimization, Linux Debugging: Proficient in Linux debugging, ARM architecture, CMake, Makefile, and GNU toolchains cross-compilation, Problem-Solving: Strong problem-solving skills and attention to detail,

Primary skills: Bachelor's or Master’s degree in electronics or similar 4-6 years of experience in automotive embedded software development Need AUTOSAR Hands-on with different ports, interfaces , and configurations Need Hands-on with OS Runnable configuration and NVM updates Need Hands-on with RTE configuration and source generation Hands-on with Davinci Configurator or equivalent Strong understanding of Compilation and linking processes. Debug skills to identify the route cause in case of build failure. Strong knowledge of version control systems (i.e. PTC integrity ) Good hands-on with the build process (build configurations for Pre/Post-build steps and build setup to a new project) Good Scripting ( Batch/Python ) knowledge to automate and debug the existing tools Knowledge to analyse map files and Hex files . Required to find the anomalies in RAM/ROM usage Good to have integration test bench preparation. To perform basic tests before final delivery and support the development teams to identify the cause of failure during CI. Secondary skills : CMM Scripts Exposure to Module/Integration/Qualification testing DOORs knowledge HIL (Control Desk, Automation desk) or LabCar/SoftCar

Support US - based audit (Construction clients) and accounting engagements. Perform financial analysis, reconciliations, and reporting in compliance with US GAAP and GAAS. Collaborate with US teams and work on cloud-based platforms.

Prepare and submit regulatory documents for product approvals, renewals, variations, and notifications. Maintain up-to-date knowledge of regulatory guidelines. Dossier preparation. Support product registration processes. Required Candidate profile 1–3 years of experience in regulatory affairs. Qualification : BSC / MSC / B Pharm Office Location : Mulund

Amdocs helps those who build the future to make it amazing. With our market-leading portfolio of software products and services, we unlock our customers innovative potential, empowering them to provide next-generation communication and media experiences for both the individual end user and enterprise customers. Our approximately 30,000 employees around the globe are here to accelerate service providers migration to the cloud, enable them to differentiate in the 5G era, and digitalize and automate their operations. Listed on the NASDAQ Global Select Market, Amdocs had revenue of $4.89 billion in fiscal 2023. In one sentence Focuses on non- functional testing with responsibility for segments of test planning, design and execution, meeting planned scope and schedule and maintaining the engagement and relationship with the customer and internal stakeholders. What will your job look like You will oversee and execute test processes, determine the proper prioritization of the testing activities and ensures integrative work and full coverage of test scenarios in accordance with plans and observations from concurrent testing activities. You will develop and implement NF automation procedures and tools. You will create and define test execution plans as well as non-functional requirements for mitigating technical risks. You will design and review test solutions and scenarios, develop NF scripts and automation utilities to be implemented and executed in alignment with the scope determined during test planning, leveraging knowledge and a broad understanding of E2E Business process & requirements You will select and apply appropriate structural design techniques to ensure that tests provide an adequate level of confidence and optimization. The tests are to be based on code and aligned with version requirements, customer needs/use and design scope You will call attention to and focuses on incident assessments. You will provide recommendations for resolution of issues and proposes improvements to the NF aspects of code, system optimization, best sizing and architecture You will ensure that product documentation, testware and work products used in the testing activities are of the highest quality to ensure traceability, correctness and compliance with product requirements and specifications, internal standards and clients' needs. You will maintain and enhance the professional and business relationship with the client/ internal customers. You will provide professional and technical support to team members and keeps them informed of assignment/ project status. Mentors new team members All you need is... 7-10 years experience in performance testing of large scale enterprise systems. Expert in developing test scripts, creating scenario, test execution and analysis usingLoadRunner / Jmeter / Neoload / Blazemeter / SOASTA / Akamai and any monitoring tool. Expert in compiling, analyzing and interpreting performance test results. Knowledge of application monitoring (e.g. HP Diagnostic, Dynatrace, AppDynamics etc.) Attention to detail and good interpersonal and communication skills Ability to understand hardware and software architectures Ability to evaluate open source performance test tools and suggest suitable one for theapplication under test Understanding of throughput, latency, memory and CPU utilization Should be ready to work in an environment which may demand individual contribution as well asa team player. Hands-on knowledge of Knowledge of SQL and PL/SQL query, C, C++, Java, Unix or any otherlanguage Why you will love this job: You will be responsible for Identifying, analyzing and mitigating non-functional issues and technical risks of software systems You will be involved in participating in and/ or leading formal and informal reviews with stakeholders

Responsibilities: * Prepare new DMF, annual reports, respond to customer queries. * Compile sequences with eCTD software, validate, submit. * List NDC drugs to FDA, prepare submissions. Provident fund

Develop procurement plans with business demand-spice commodities Identify, evaluate, onboard reliable spice suppliers - farmers, FPOs, traders, vendors Negotiate pricing, payment & delivery terms Monitor market, seasonal availability, price changes Required Candidate profile Prepare RFQ & issue PO & timely follow up Track inventory & coordinate procurement Coordinate with logistics partners for shipping, customs clearance Track procurement spending & cost cutting

RSM is looking for a dynamic Manager to join our Assurance team. You will have the opportunity to work as a team member on diverse client engagements. Our clients include local, national and internationally recognized companies. RSM s assurance professionals helping companies improve their performance through the most challenging business cycles. Responsibilities Perform Review and Compilation engagements in accordance with firm and professional standards as directed by engagement leaders. Design, develop, and execute analytical procedures to assess financial data and performance metrics. Review and analyze lease agreements to ensure compliance with lease accounting standards (e.g., ASC 842), including calculation of lease liabilities, right-of-use assets, and related journal entries. Responsible for overseeing the accurate and timely preparation of financial statements, including income statements, balance sheets, and cash flow statements, ensuring compliance with accounting standards and regulations. Prepare detailed supporting schedules for financial statement analysis and review, ensuring accuracy and compliance with accounting standards, to facilitate comprehensive reporting and decision-making for managerial review. Revenue recognition procedures to ensure compliance with regulatory requirements and accurately reflect earned revenue, optimizing financial transparency and accountability Required Qualifications Bachelor of Commerce (Accounting) degree or equivalent degree from an accredited university Licensed CPA / Qualified CA 5+ years of current or recent experience in a public accounting environment 7 plus years' experience in Canda Corporate tax return/compilation/review engagement related field Experience leading teams and mentoring associates Understanding of accounting services, with knowledge of review and compilation standards A proven record of building profitable, sustainable client relationships Minimum of 4 years of team lead or in-charge experience overseeing staff on multiple engagements Preferred Qualifications Experience with managing review and compilation engagements including the applicable taxation. A successful record of directing and deploying staff and senior associates on multiple, simultaneous engagement Preparing financial statements, conducting compilations and reviews, and completing Canadian corporate tax returns. empowering you to balance life s demands, while also maintaining your ability to serve clients. Learn more about our total rewards at https://rsmus.com/careers/india.html .

Roles and Responsibilities Prepare dossiers for regulatory submissions, including compilation of data from various sources into a cohesive document. Review and compile dossiers prepared by others to ensure accuracy and completeness. Coordinate with internal departments (e.g., CMC, Non-Clinical Toxicology) and external vendors/consultants to obtain necessary information for dossier preparation. Ensure timely submission of dossiers to relevant authorities (e.g., FDA, EMA). Maintain accurate records of all correspondence with regulatory agencies. Desired Candidate Profile 5-8 years of experience in Regulatory Affairs or related field (B.Pharma / M.Pharma degree required). Strong understanding of drug regulatory affairs, particularly in Europe market. Proficiency in compilation, dossier preparation, and regulatory submissions.

Hello all GNU/Linux fans and geeks! Nakshatra Systems is looking forward to hire a Linux Software Repository maintainer, who can service, maintain, upgrade/udpate and manage the software repository. Job is Work from home and contract based. Looking for immediate joiners. Contract job of 1 year. Candidate will have to sign a legal agreement that will include NDA and NCA. Vacancy : 1 Minimum experience needed : 1 - 2 years Mandatory technical skills : ============================= Compiling and creating software from source code. Ability to create software packages using package creation tools to install/remove software. Creating/Updating packages. Keeping track of software dependencies. creating / providing / managing software patches Monitoring and staying current with CVE's Maintaining Changelogs and other documentation. Providing bug fixes. Reviewing changes. Proficiency in linux commands, filters, bash scripting, C and python. Knowledge of patch command and other similar software management tools. Connect with upstream developer for solutions if needed to get issues resolved. Good troubleshooting skills. Knowledge of Slackware Linux a HUGE plus. As Nakshatra Linux is a clone and a derivative of slackware linux , candidates with knowledge of slackware will be prioritized over to those with knowledge of redhat/debian. Non-technical pre-requisites : ============================== Should be fluent in english with good verbal and written skills Since nature is work from home , a good broadband internet connection (at least 50 mbps) with IPV6 facility is mandatory for remote logins and work. Ability to work in team as well as independently. Should be able to resolve assigned tasks in the specified time-frame/deadlines. Candidates with matching skill set that are shortlisted will be contacted via phone for a technical telephonic interview. This is not a sysadmin profile job.

Role & responsibilities Keen Knowledge on Regulatory guidelines for finished product registration. Dossier compilation as per guidelines. Compilation and review the product dossiers for submission in CTD, ACTD . Gap analysis of the dossier and addressing the gaps before submission to MOH. Handling the customer and MOH queries . Life cycle management of the product. Development report, scale up report , specification, COA, stability protocol and Process validation protocol. Documents review (Specification, STP, Analytical method validations, Development report and validation reports, BMR, BPR, PVP/R and stability). Post approval experience to file the applicable variations timely. Knowledge on EAEU, ICH and EMEA guidelines. Re-registration (Renewal) procedures. Administrative documents requirements (COPP, Mfg. License and Import License) . Registration information management system updates on regular basis.

Role & responsibilities Lead the compilation, analysis, and reporting of global management information systems (MIS) and financial performance, ensuring accuracy and consistency across all regions. Review forward-looking financial plans and forecasts from global entities, comparing them with historical trends and actual performance to highlight key variances and business risks. Conduct comprehensive financial analysis across entities and product portfolios, including profitability, cost structures, and operational performance. Report deviations and key insights to senior global management. Design, implement, and continuously improve global cost allocation models and methodologies to ensure fair and transparent distribution of shared costs. Develop and deliver management reports, dashboards, and insights tailored to the needs of the senior global leadership team. Maintain a centralized database of financial and technical data for key products, including both launched and pipeline products. Support supply chain cost analysis and inventory performance reviews to enhance efficiency and cost control. Collaborate with Group Accounting during month-end close to validate results and provide performance commentary. Prepare high-quality financial reports and presentations for board meetings, shareholder communications, and other executive forums. Participate actively in global finance transformation projects, systems upgrades, and process improvement initiatives. Provide ad-hoc analytical support to the global leadership team, including market research, competitive analysis, and industry benchmarking to inform strategic decisions, legal matters, and investor relations. Qualification Requirements: MBA or MBA with CA or CA with relevant experience in FP&A. At least 5+ years FP&A experience from Pharma or FMCG industries. Experience working with cross-functional and cross-regional teams. Strong proficiency in MS Excel, PowerPoint, and dashboard creation tools such as Power BI. Expertise in global cost allocation, planning systems, and management reporting tools. Working knowledge of SAP ERP systems. Strong analytical mindset, attention to detail, and a proactive approach to problem-solving. Demonstrated ability to meet tight deadlines and prioritize effectively. Fluency in English language is mandatory

Role & responsibilities Extensive Knowledge in Pre-Submission activity and handling new product submissions. Handling of post approval activities (US/EU and ROW) Experience in handling life cycle management Activities. Line Extension and New Submissions. Well versed in applicable regulatory and country specific guidlines.

Immediate Joining | Remote | | Part Time - Visiting Faculty Impart Training Sessions for the students of Drug Regulatory Affairs Weekend Training Sessions Prepare presentations Deliver Training Sessions