70 Submission Jobs - Page 2

2–4 years of experience in the US Insurance domain. Support US Account Managers with: Loss run ordering, cancellations, reinstatements Premium comparisons, invoicing, quoting, and rating Use of systems like AMS360, ImageRight, Applied EPIC, Nexsure

We are seeking a highly experienced and detail-oriented Regulatory Affairs Specialist with 5 to 15 years of experience in the pharmaceutical industry, specifically handling regulatory requirements for ROW (Rest of the World) / PICs (Pharmaceutical Inspection Co-operation Scheme) markets. The ideal candidate will have strong expertise in dossier preparation, international registration processes, and a solid understanding of global regulatory frameworks including ICH CTD, ACTD, and EU CTD formats .

Roles and Responsibilities Prepare ANDA dossiers, CMC modules, and submission documents for US FDA approval. Post approval and life cycle management of approved ANDA & suppliment filling. Review and prepare labeling documents (labels, cartons, pack insert) according to US regulations. Develop expertise in various therapeutic areas such as Cardiology, Diabetology, Neurology, Ophthalmology etc. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Ensure timely submission of applications to USFDA while maintaining high-quality standards. Desired Candidate Profile 8-10 years of experience in Regulatory Affairs with a focus on US market. Bachelor's degree in Pharmacy (B.Pharma) or Master's degree in Pharmacy (M.Pharma). Strong understanding of dossier preparation guidelines for USFDA submissions. Excellent communication skills for effective collaboration with internal stakeholders.

As a Backoffice Executive, your primary responsibility will involve conducting data-based field investigations. You will be required to coordinate with your supervisor to ensure that 100% compliance is followed during the investigation process. Timeliness and accuracy in field investigations are crucial, with a minimum of 30 cases, including Pre/Post FI, to be conducted every month before the deadline. Both online and offline investigations will need to be carried out as per the instructions provided by your supervisor. Additionally, you should be prepared to travel extensively as per the requirements of the company. One of your key tasks will be to prepare and submit investigation findings to your supervisor in a timely manner. Your role as a Backoffice Executive will play a vital part in ensuring that all field investigations are conducted efficiently and effectively, contributing to the overall success of the company's operations.,

CA with 3-7 years of experience Conduct inspections, ensure timely reporting & compliance by Business Partners Identify & implement improvements in the existing inspection processes Monitor and review periodic submissions as per Compliance Calendar Required Candidate profile Coordinate for BPs, HO, and IT to enhance systems, controls & training Ensure proactive and timely compliance from all BPs Readiness to travel based on business requirement Immediate Joiners preferred

•Direct the preparation and submission of regulatory agency applications, reports, or correspondence. •Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards. Required Candidate profile Experience in Regulatory Affairs function with experience in preparing DMF for US / EU / Japan / ROW market and handling their queries / deficiencies.

As a professional in the field of accounting and taxation, your primary responsibility will be to provide advice, support, and review of statutory matters related to GST. This includes tasks such as the preparation, reconciliation, and filing of GST returns, particularly focusing on GST Annual Returns and various forms such as GSTR-1, GSTR-3B, GSTR-6, and the annual return. It is imperative that you possess a strong working knowledge of GST to ensure accurate preparation and submission of GST claims. Additionally, you will be tasked with reviewing audit working papers prepared by staff members, ensuring that they are properly referenced, complete, and compliant with audit requirements. You will also have the opportunity to conduct related audits based on the annual plan in a highly professional manner, adhering to Audit standards throughout the process. The ideal candidate for this role will hold a minimum qualification of M.Com/B.Com and possess at least 1 year of relevant work experience in the field of accounting and taxation. This role currently has vacancies in Visakhapatnam (2 positions) and Pune (1 position). If you are seeking a dynamic role that allows you to apply your expertise in GST, audit, and compliance, this position offers a challenging yet rewarding opportunity to contribute to the success of the organization.,

Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile and Allergy Therapy Products, and Generics Solid Dosage Formulations. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma which is subsidiary to Jubilant Pharmova Limited. Jubilant Generics have 2 manufacturing sited at Roorkee, Uttarakhand and Salisbury, Maryland, USA engaged in manufacturing of Tablets and Capsules. The manufacturing location at Roorkee, Uttarakhand is state of the art facility and is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA. This business team focusses on B2B model for EU, Canada and emerging markets. Kindly refer www.jubilantpharmova.com for more information about organization. JOB RESPONSIBILITIES : ;;;;;;;;;;;;; Accountabilities;;;;;;;;;;;;;;;;;;;;;;;;;;; Scope of work US Drug Dossier Authoring, Reviewing and Submission of ANDA (US) Product life cycle management (LCM) activities Assessment of post approval changes eCTD publishing Thorough knowledge of CMC and Module 1 requirements Labelling submission, SPL preparation Preparation and Submission Authoring and review, compilation and submission of ANDA, DMF review and assessment, Query evaluation and response for under review ANDA within timeline. Assessments of post approval changes and submissions (Annual report, CBE-30, PAS), life-cycle maintenance and ensure timely post approval regulatory activities. Artworks (PIL, labels) and labeling files preparation along with SPL preparation. Coordinate with cross-functional teams for desired regulatory data and accordingly plan and complete regulatory filing activities Review and finalization of artwork/label as per current guideline. Regulatory Intelligence and develops up-to-date knowledge with regard to technical guidelines and regulatory requirements, as well as technical trends eCTD publishing Coordination Interface with R and D and other business functions on a regular basis to ensure project-specific regulatory strategy is met as agreed in timely manner Co-ordination with API vendors to resolve technical quires w.r.t. regulatory requirements To review technical documents like process validation, AMV, Stability and composition etc. received from Site QA or R and D/ADL against DMF/Dossier requirements Reporting and Maintenance Maintain regulatory files/database

To ensure that products with all regulations and legislation, both National and international,throughout the product lifecycleThe RAP works closely with R&D manufacturing QA/QC and mkt to ensure timely registration,compliance and approval of products

Riya Travels & Tours Pvt. Ltd. Designation: Visa Consultant Location: Bangalore, Chennai Role & Responsibilities: Manage visa processing for corporate clients , ensuring accurate documentation and timely submission for business and tourist visa categories. Handle end-to-end corporate visa booking , including appointment scheduling , document verification, and follow-up with embassies and consulates . Process visa applications for countries like USA, UK, Schengen, Canada, and New Zealand (any 2-3 key regions preferred). Communicate with corporate teams to gather necessary documentation and keep them updated on visa statuses. Draft clear and professional emails for corporate clients and internal stakeholders. Maintain updated and confidential records of visa applications and client interactions. Stay informed on visa process updates and compliance requirements, ensuring clients are aligned with the latest regulations. Preferred Candidate Profile: 2 to 5 years of hands-on experience in corporate visa processing & booking . Strong understanding of corporate visa appointment booking platforms and embassy processes. Experience managing corporate travel documentation & coordination . Excellent written and verbal communication skills to manage email correspondence and client calls . Proven track record in managing high-volume visa requirements for corporate clients . Willing to work from office or at implant locations (Bellandur) as required. Key Skills: Visa Processing, Corporate Visa Booking, B2B Appointment Scheduling, Client Coordination, Documentation Management, US/UK/Schengen Visa Handling, Email Drafting, Travel Industry, Business & Tourist Visa Processing.

Carries out tasks requiring physical presence at various locations. Customer service Reporting performance metrics Route Following Deliverable Collection and Submission Perks and benefits 2.75 Rps /KM Convenience Fee Retention Bonus- 1000

Understanding the requirements tender documents preparing bid proposals GEM portal such as engineering procurement and finance Preparing and submitting including bid preparation contract negotiation public sector projects (Electrical Engineer)

Role & responsibilities Stay current with evolving regulations related to Sulphur import/export in different countries, including customs regulations, trade agreements, and safety standards. Documentation: Prepare and manage import/export documentation, including permits, licenses, certificates of origin, invoices, and shipping documents. Compliance: Ensure compliance with all relevant import/export laws, regulations, and trade agreements for Sulphur. Supplier/Customer Relationship Management: Work with suppliers and customers to ensure compliance with import/export regulations. Licensing and Permitting: Obtain and maintain necessary import/export licenses and permits for Sulphur shipments. Record Keeping: Maintain accurate records of all import/export transactions. Communication: Communicate with customs authorities, government agencies, and other stakeholders to ensure compliance. Problem Solving: Identify and resolve regulatory issues related to Sulphur import/export. Collaboration: Collaborate with other departments, such as logistics and finance, to ensure seamless import/export operations. Audits: Prepare for and respond to regulatory audits related to import/export activities. Preferred candidate profile Bachelor's degree : in a relevant field, such as international business, logistics, or law Understanding of international trade laws, customs regulations, and other relevant regulations. Experience : in regulatory affairs, import/export, or customs compliance. Ability to prepare and manage import/export documentation accurately and efficiently. Ability to communicate effectively with customs authorities, government agencies, and other stakeholders.

Greetings from Veritis!!! *Hiring for the role of US IT Recruiter* About Veritis: Veritis is a global IT consulting services provider based out of Texas, United States. Veritis consulting services include a wide range of technology service offerings such as Cloud, Containerization, DevOps, Digital Transformation, Identity and Access Management, IT Infrastructure, Managed Services, Technology Advisory and Virtualization Services. Roles and Responsibilities : Any Degree with 2+ years of relevant experience. In-depth knowledge of hiring practices and existing laws with respect to the US market. Experience in building the talent pool for the IT department of the company. Must be comfortable working in EST and PST shifts. Experience in recruiting US Citizens and Green Card holders. Knowledgeable about different US work Visas like H1B, E3, and TN. Familiarity with different US Tax terms is required (1099/W2/Corp-Corp). Strong understanding of technical requirements. Ability to display deep sourcing skills and excellent candidate assessment skills. Should be self-motivated as well as a team Player. The ability to think analytically so as to consider all applicants and recommend the right fit for the organization. Should have excellent oral and written Communication skills as well as the ability to network in order to build an exemplary IT department for the company. Proficient in English. Job Type: Full Time Shift : EST TimeZone (6.30 pm - 3.30pm) Interested candidates can share their resume at priya.d@veritis.com

Role & responsibilities - Dossier preparation, review and submission in ACTD/CTD/ Country specific formate and also in ROW. - Review of technical documents - Responding to dossier - related queries. - License related activity. - Strong coordination with functional related department. Preferred candidate profile Dossier Preparation, Submission, Technical Review

Greetings from Veritis!!! *Hiring for the role of US IT Recruiter* About Veritis: Veritis is a global IT consulting services provider based out of Texas, United States. Veritis consulting services include a wide range of technology service offerings such as Cloud, Containerization, DevOps, Digital Transformation, Identity and Access Management, IT Infrastructure, Managed Services, Technology Advisory and Virtualization Services. Roles and Responsibilities : Any Degree with 2+ years of relevant experience. In-depth knowledge of hiring practices and existing laws with respect to the US market. Experience in building the talent pool for the IT department of the company. Must be comfortable working in EST and PST shifts. Experience in recruiting US Citizens and Green Card holders. Knowledgeable about different US work Visas like H1B, E3, and TN. Familiarity with different US Tax terms is required (1099/W2/Corp-Corp). Strong understanding of technical requirements. Ability to display deep sourcing skills and excellent candidate assessment skills. Should be self-motivated as well as a team Player. The ability to think analytically so as to consider all applicants and recommend the right fit for the organization. Should have excellent oral and written Communication skills as well as the ability to network in order to build an exemplary IT department for the company. Proficient in English. Job Type: Full Time Shift : EST TimeZone (6.30 pm - 4.40pm) Interested candidates can share their resume at priya.d@veritis.com

Co-ordination with all departments, collection of documents required for regulatory filing, DMF compilation, API document review for adequacy of regulatory submission, supporting activities for business development

•Direct the preparation and submission of regulatory agency applications, reports, or correspondence. •Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards. Required Candidate profile Experience in Regulatory Affairs function with experience in preparing DMF for US / EU / Japan / ROW market and handling their queries / deficiencies.

Experience in US FDA regulatory submission and query response along with handling of Control correspondence. Good Knowledge in Current US FDA Guidelines and MAPP Preparation of Module 1-5, Review and submit through eCTD software. Exposure to 505(j) and 505(b)(2) NCE-1 based submission. Experience in DMF review. Prepare, review, and submit regulatory submissions for Product life cycle management. Collaborate with cross-functional teams (R&D, Quality, Clinical) to ensure regulatory compliance. Develop and implement regulatory strategies to support product approvals and lifecycle management. Monitor regulatory intelligence and assess the impact of regulatory changes on the business. Working knowledge of clinical trial regulations and GxPs. Proficiency in regulatory software or document management systems Please share your CVs @ Kavya.c@viyash.com

Key responsibilities include: Responsible for all Regulatory related activities includes Filing, Submission, responding to DCGI queries, Customer requirements, SUGAM portal registrations, Renewal of licenses, IP commission & CDTL requirements, etc. Responsible to get approvals for the submissions to CDSCO like New drug application, FDC application, Subsequent new drug application, Import license, Test license, etc. Responsible for FSSAI annual returns filing, FosCos online license modification. Responsible for handling PV related activities, which includes PSUR submission and reporting the adverse events of pharmaceutical products for case processing, reviewing & submitting the reports to regulatory authorities. Filing & Submissions: Responsible to prepare submissions to CDSCO like New drug application, Subsequent new drug application, etc. and ensures to respond the DCGI queries & SEC recommendations in timely manner to get permissions/approvals. Responsible to collect & review all the essential documents (API vendor documents, CMC documents, Administrative part, Clinical & Non-clinical data) from CFT for submission. Managing the queries raised by CDSCO against the submitted applications and responsible for addressing the queries & requirements from Indian Pharmacopeia Commission, Central/State Testing Laboratories, SEC committee, DCGI, CDSCO. Regulatory Compliance Management Supports in customer / regulatory complaints, including reply to complainant, investigations, corrective and preventive actions and evaluations of effectiveness of corrections. Ensures that customer / regulatory complaints are adequately handled, including reply to complainant, investigations, corrective and preventive actions and evaluations of effectiveness of corrections. Evaluates, reviews and approves product claim on labels and marketing collaterals in accordance to legal and regulatory requirements. Responsible to organize and archive all regulatory documents including NOC, Product license, NSQs data, AE reports, Drug office requests by co-ordination with site Co-ordinate with the Consultants and Customers on regulatory requirements for new products and major changes in existing products. Reviews proposed changes and its supportive information for completeness and accuracy while ensuring compliance with regulations set by the Central Drugs Standard Control Organization (CDSCO) Responsible for Monitoring of Compendial/ Pharmacopeial revisions or any addition of new monographs, which impacts our system and procedure and ensuring the changes implemented in License, Artwork labelling, specification, testing methods, BMR, BPR, MMR and procedures at all sites Communicate changes in regulatory directions, regulatory intelligence and competitive activities. Notify internally via RA notification as necessary within all relevant regulatory matters Pharmacovigilance Management Responsible for submission of Periodic Safety Update Reports (PSUR) to regulatory authority as a part of new product approval/regularization within stipulated timeline. Responsible for reporting the Adverse Event PV, follow up, coordination with site QA (in case of quality complaint) and provide investigation report to customers and getting the concurrence / approval from customer on investigation and closure. Co-ordinate with CRO for processing AE cases & responsible for reviewing and submitting the reports to regulatory authorities on time. Assisting in PV projects in compliance with customer agreement and local & global regulatory guidelines. Maintain and track all CAPAs & submitted reports related to pharmacovigilance. Ensure pharmacovigilance regulatory compliance with oversight, as needed. FSSAI (Food Safety & Standards Authority of India) To perform & ensures on-time FSSAI annual returns filing (Form ‘D’) periodically. Responsible for central FSSAI license modification by including addition of products time to time and other licensing activities like Free Sale Certificate. Ensures regulatory compliance related to registration of Food Business Operator through Food Safety Compliance System (FoSCoS), Food safety audit, etc. Quality management (NSQ): Co-ordinates with site team & ensure to fulfil the drugs control requirements (Documents/ Sample) of concern FDA/DCD/DTL by responding within stipulated timeline. Collaborate & Coordinate with internal team to make a strategic plan to respond the NSQ/Showcause cases.

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

We are seeking a highly skilled and motivated Product Delivery Manager / Program Manager to lead and oversee the development of automotive product line (Preferably BMS, IVI). The Program Manager will be responsible for coordinating cross-functional teams, managing timelines, and ensuring the successful delivery of innovative embedded products that meet safety, regulatory, and performance standards. Key Responsibilities: Project Planning & Execution: Lead the planning, execution, and delivery of automotive embedded systems projects from concept to production including Systems and SW process areas/ subsystems, ensuring alignment with customer requirements, timelines, and budgets. Team Leadership: Manage a multidisciplinary team of engineers, designers, and testers to deliver high-quality embedded system for automotive products (e.g., IVI, BMS). Stakeholder Management: Act as the primary point of contact for internal teams and external stakeholders, including customers, suppliers, and regulatory bodies. Ensure clear communication on project status, risks, and opportunities. Risk Management: Identify, assess, and mitigate risks throughout the project lifecycle, ensuring compliance with automotive industry standards (such as ASPICE, ISO 26262, and cybersecurity). Resource Allocation: Allocate and manage resources efficiently to meet project deliverables, adjust strategies as needed to address challenges in the project lifecycle. Documentation & Compliance: Oversee project documentation, ensure adherence to regulatory and safety standards (e.g., functional safety standards, cybersecurity guidelines). Quality Assurance: Work closely with the QA team to ensure that all deliverables meet industry and customer standards, from early development stages to final validation. Generate metrics as needed. Budget Management: Monitor project budgets, control costs, and ensure the project remains financially viable. Required Qualifications: Education: Bachelor's degree in Electronics Engineering, Computer Engineering, or a related field. Experience: 12-15 years of experience in embedded product development in automotive industry, with at least 3+ years in a program management role within the automotive industry. Technical Expertise: o Strong understanding of Systems and Software development including design and environmental aspects. o Strong understanding of Model based development, MIL, SIL etc. o Strong understanding of BMS, IVI/ ADAS systems. o Strong Knowledge in technical and commercial Prposal submissions. o Strong understanding of automotive embedded systems, including microcontrollers, real-time operating systems (RTOS), communication protocols (e.g., CAN, LIN, Ethernet). o Familiarity with automotive safety standards such as ISO 26262, and process such as ASPICE. Program Management Skills: o Proficiency in program management tools (e.g., Azzure, Microsoft Project, Jira, PPT, Excel, Power BI). o Knowledge of Agile and Waterfall methodologies. o Certification in PMP or PRINCE2 is preferred. Roles and Responsibilities Identifies research and development areas that should be investigated. Responsible for attaining laboratory or department research, marketing, fiscal and staffing goals to conform to organization goals. Establishes operating procedures, practices and guidelines and communicates them with laboratory or department personnel. Establishes, monitors and controls schedules and project budgets. Plans, organizes and manages work of research and support staff. Responsible for negotiation or research contracts. Plans and manages business development and marketing activities for laboratory or department. Develops solutions to complex research problems.

Preparation of: Municipal Drawing / Drafting Challan calculations (PMRDA related task) Filing the necessary documents & file preparation. Letter drafting (all kinds of letters) to authorities: Query solving Covering letters etc. All kinds of drawings: Designing, Sale Plans, Submission, Working Drawings, Detailing of all drawings Periodical site visits Periodical Liasoning visits to PMRDA / PMC Software skills - Autocad, Microsoft office.

To manage and drive the implementation, monitoring, and compliance of all government-sponsored schemes (e.g., PMEGP, CGTMSE, MUDRA, Stand-Up India, etc.) across branches and ensure timely reporting, subsidy claims, and liaison with government agencies Roles and Responsibilities Ensure timely submission of claims for interest subvention/subsidies. Liaise with government departments, SIDBI, NABARD, etc., for approvals and updates. Track scheme-wise portfolio performance, NPA levels, and MIS reporting. Conduct periodic training sessions for branch staff. Prepare and share scheme-specific dashboards and updates with management. Ensure audit compliance and internal controls in all scheme-related operations

ABOUT XENONSTACK XenonStack is the fastest-growing data and AI foundry for agentic systems, which enables people and organizations to gain real-time and intelligent business insights. Building Agentic Systems for AI Agents with https://www.akira.ai Vision AI Platform with https://www.xenonstack.ai Inference AI Infrastructure for Agentic Systems - https://www.nexastack.ai THE OPPORTUNITY We are seeking an enthusiastic Software Trainee Marketing to support campaign management and analyze marketing data. If you are eager to learn, have strong communication skills, and a passion for marketing, we’d love to have you on our team. Job Role and Responsibilities Assist in implementing SEO strategies to optimize website content and improve search rankings. Conduct keyword research and analysis to identify opportunities for content optimization. Collaborate with the marketing team to develop and execute digital marketing campaigns. Help in tracking and analysing key performance indicators (KPIs) for online campaigns. Stay up to date with the latest trends, best practices, and updates in the digital marketing landscape. Support content creation by ensuring it follows SEO guidelines and drives engagement. Assist in the management and optimization of social media platforms and online presence. Skills Requirement Bachelor's degree in marketing, Communications, Business, or a related field. 0-1 year of hands-on experience in digital marketing or internships. Basic knowledge of SEO, keyword research, and content optimization techniques. Familiarity with Google Analytics, SEMrush, or other digital marketing tools is a plus. Strong enthusiasm for digital marketing and staying updated with trends. Excellent written and verbal communication skills. Ability to collaborate in a fast-paced, team-oriented environment. Detail-oriented with a passion for problem-solving and optimization. Familiarity with social media platforms and their marketing potential. Career Growth and Benefits 1) Continuous Learning & Growth Access to certification courses & skill-building sessions for professional development. Exposure to cutting-edge technologies and business analysis strategies. 2) Recognition & Rewards Regular constructive feedback to help you grow. Performance-based incentives and rewards. Special recognition for outstanding contributions and work ethic. 3) Work Benefits & Well-Being Comprehensive medical insurance for health security. Additional allowances for team members assigned to specific projects and Cab facility for women employees. XENONSTACK CULTURE- JOIN US & MAKE AN IMPACT! Here at XenonStack, we have a culture of cultivation with bold, courageous, and human-centric leadership principles. We value obsession and deep work in everything we do. We are on a mission to disrupt and reshape the category and welcome people with that mindset and ambition. If you are energised by the idea of shaping the future of AI in Business processes and enterprise systems, there’s nowhere better for you than XenonStack Product Value and Outcomes - Simplifying the User experience with AI Agents and Agentic AI1) Obsessed with Adoption : We design everything with the goal of making AI more accessible and simplifying the business processes and enterprise systems essential to adoption. 2) Obsessed with Simplicity : We simplify even the most complex challenges to create seamless, intuitive experiences with AI agents and Agentic AI. Be a part of XenonStack’s Vision and Mission for Accelerating the world's transition to AI + Human Intelligence.