152 Submission Jobs - Page 6

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 kno...

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 re...

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 Leadersh...

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 ...

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 ...

THE ROLE Demand for our Functional Service Provision is growing we are therefore looking for a driven and passionate Statistical Programmer to join our reputable FSP team to support one of our fantastic US based pharmaceutical clients. We are looking for an experienced Programmer with ISS / ISE and submission experience, who is versatile and flexible to work on various therapeutic areas. The successful individual must be able to program / QC ISS and ISE datasets, as well as TLFs and will have experience with building macros and standards. This is a fantastic opportunity to work for a growing CRO that is recognized for its continuous learning and development opportunities, whilst also gaining...

Title We are currently seeking an full time office based Experienced Study Start up Submissions Coordinator to join our Clinical Operations team in India Mumbai. This role is a vital part of the team to accomplish tasks and projects that are instrumental to the company’s success. If you are interested in an exciting career where you can use your expertise and develop and grow your career even further, then this is the opportunity for you. Our culture is of expertise, and we empower our teams to employ their unique talents and experience to take an assertive approach to research, problem solving, and ultimately supporting our business partners. At Medpace, our employees embody our values and ...

Title We are currently seeking a full-time, office-based Study Start up Submissions Coordinator to join our Clinical Operations team in Mumbai, India office. This role is a vital part of the team to accomplish tasks and projects that are instrumental to the company’s success. If you are interested in an exciting career where you can use your expertise and develop and grow your career even further, then this is the opportunity for you. Our culture is of expertise, and we empower our teams to employ their unique talents and experience to take an assertive approach to research, problem solving, and ultimately supporting our business partners. At Medpace, our employees embody our values and our ...

Responsibilities: * Documentation keeping/ printing/ handling/ submission * Ensure timely submissions * Maintain accurate records * Coordinate with clients & vendors & banks & etc

Role & responsibilities Manage billing operations, including cash billing, credit management, and insurance claims processing. Oversee submission of medical bills to various healthcare organizations (insurance companies) for reimbursement. Handle collections from patients or insurance companies as needed. Ensure accurate and timely submission of claims to avoid delays in payment. Coordinate with internal teams to resolve any discrepancies or issues related to billing. Preferred candidate profile 10-15 years of experience in hospital billing, preferably in a leadership role. MBA/PGDM degree from a recognized institution. Strong understanding of hospital management principles and practices. Ex...

Roles and Responsibility : To review and arrange required documents to corporate RA for dossiers, query response. To review artwork in artwork management system. R apply product permission, NOC for all manufactured product.R

Key Responsibilities: Strong understanding of eCTD, NeeS, and ICH guidelines. Familiarity with Regulatory systems and Publishing tools. Use publishing tools such as: Lorenz Docubridge, Ectd Validator, ISI Toolbox, Adobe Acrobat, MS Excel, SharePoint. Ability to perform end-to-end eCTD submission process, including Document level Publishing and Dossier compilation, and dispatch of submissions to respective Health Authorities (Developed and ROW Markets) Manage lifecycle submissions including variations, amendments, and renewals. Perform document-level publishing, hyperlinking, bookmarking, and validation. Conduct quality control checks to ensure submission readiness. Collaborate with cross-fun...

• Develop and review content for various regulatory documents; ensure quality as per setegulatory standards and compliance requirement. • Good understanding of global regulatory dossier formats and ACTD/CTD/NeeS/paper dossier format. • Candidate will need to author and/or review clinical and non-clinical documents under Module 2, 4 and 5 of eCTD, and Part III and Part IV of ACTD for submission to the Health Authorities in EU and APAC markets, respectively. Key requirement: • Good medical/pharma/scientific knowledge that can be applied in developing content for regulatory documents • Experienced in the development and review of clinical and non-clinical documents under Module 2, 4 and 5 of eC...

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 o...

Opening for - Manager, Regulatory Affairs - CMC@ Mumbai , Pune and Hyderabad location. Experience : 5 to 10 Yrs relevant experience in RA CMC This Role is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidances and defined regulatory strategies. He would even be responsible for the preparation and review of information required for development of regulatory CMC dossiers for commercial products. Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network ...

Roles and Responsibilities Prepare dossiers, variations, renewals, and amendments for regulatory submissions to FDA and other global health authorities. Coordinate with cross-functional teams to ensure timely submission of regulatory documents. Maintain accurate records of all regulatory correspondence, reports, and audit findings. Ensure compliance with regulatory guidelines and requirements by reviewing documentation and conducting internal audits. Provide support during regulatory audits by gathering necessary information and preparing responses. Desired Candidate Profile 1-4 years of experience in Regulatory Affairs or related field (pharmaceutical industry). Bachelor's degree in Pharmac...

Knowledge of registration requirements and procedures in LATAM (e.g., Brazil, Mexico, Argentina, Colombia, Peru, Chile) and other ROW countries (e.g., Africa, CIS, Southeast Asia). Experience with dossier preparation in CTD/ACTD/non-CTD formats. Familiarity with country-specific labeling, packaging. Strong communication, coordination, and documentation skills. Proficient in MS Office, document management tools, and regulatory tracking systems. Dossier Preparation: Compile, review, and submit registration dossiers (CTD/eCTD formats) for domestic and export markets (e.g., ROW, semi-regulated, and regulated markets). Regulatory Submissions: Handle regulatory filings for new product approvals, r...

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

Overview THE COMPANY Phastar is a multiple award-winning global biometric Contract Research Organization (CRO) that is accredited as an outstanding company to work for by Best Companies. We partner with pharmaceutical, biotechnology and medical device organizations to provide the expertise and processes to manage and deliver on time, quality biostatistics, programming, data management and data science services. With offices across the UK, US, Germany, Denmark, Kenya, Australia, India, China and Japan, Phastar is the second largest specialized biometrics provider globally, and the largest in the UK. Our unique approach to data analysis, The Phastar Discipline, has led us to build a reputation...

Overview We have an exciting role of Medical Writer to drive and translate creative and contemporary ideas to solid design and impact. You will have a key role in design and deployment of creative campaigns with our global clients, including many Fortune 50 companies. Responsibilities Lead and manage a team, providing guidance, mentorship, and support to ensure their professional growth and enhance the quality of output Develop a refined understanding of the brand, disease, and the overall therapeutic/treatment category. Ensure all content is created with appropriate tone, style, and structure based on brand strategy, creative brief, and client expectations Demonstrate a sound understanding ...

Subject: Unlock Your Potential in the US P&C Insurance Domain at ReSource Pro India! Join Our Dynamic Team at ReSource Pro India! Are you ready to elevate your career in the US Property and Casualty (P&C) Insurance sector? We're on the hunt for passionate professionals with the following expertise: Experience Required: 3 - 5 years Key Skills: Mastery in Rating/Online Rating, Quoting, Submissions, and Endorsement tasks. In-depth knowledge of Lines of Business (LOBs) such as Workers Compensation, Business Owners Policies, General Liability, BOP, etc. Advanced skills in MS Excel. Strong communication abilities. Why Choose Us? Innovative Environment: Be part of a forward-thinking team that value...

Process Study& Calculation / Plant Hydraulic Design Develop& maintain strong material supplier master& vendor database Support project team during project execution& address technical issues Take quote from OEM/ vendors, discuss technical specs Required Candidate profile Process Design Knowledge of ETP (Biological&Inorganic)with ZLD (MEE)&STP plant with MBBR,MBR Technology Able to write complete Techno-Comml. Proposal Technical competency to deliver solution to client Perks and benefits Nego. Based on experience, Skills& ZLD Experience.

Lead the preparation, review, and submission of new regulatory dossiers for Solid Oral Dosage Forms (SODF), Injectables, and/or Ophthalmic products to regulated markets. Lifecycle,Labelling Management, Stakeholder,Team Leadership,Process Improvement