108 Regulatory Submissions Jobs - Page 5

We are seeking a highly motivated Fresher Clinical Data Manager to join our clinical data management team. In this role, you will assist in managing, cleaning, and validating clinical trial data, ensuring data quality and compliance with regulatory stndards. This is an exciting opportunity for someone looking to start their career in clinical data management and gain exposure to the clinical research process. Manage and analyze clinical trial data, ensure data accuracy, and support regulatory submissions. Work mode Remote/Hybrid

We are seeking a highly motivated Fresher Clinical Data Manager to join our clinical data management team. In this role, you will assist in managing, cleaning, and validating clinical trial data, ensuring data quality and compliance with regulatory stndards. This is an exciting opportunity for someone looking to start their career in clinical data management and gain exposure to the clinical research process. Manage and analyze clinical trial data, ensure data accuracy, and support regulatory submissions. Work mode Remote/Hybrid

We are seeking a highly motivated Fresher Clinical Data Manager to join our clinical data management team. In this role, you will assist in managing, cleaning, and validating clinical trial data, ensuring data quality and compliance with regulatory stndards. This is an exciting opportunity for someone looking to start their career in clinical data management and gain exposure to the clinical research process. Manage and analyze clinical trial data, ensure data accuracy, and support regulatory submissions. Work mode Remote/Hybrid

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

Hi We are hiring for Regulatory Submissions Publisher . Job Purpose: Build and process submission dossiers of low-to-moderate complexity: Submission Dossiers that may be periodic (e.g.: safety reports) or minor amendments (e.g.: IND Amendment, DMF Amendment, CMC Update as appropriate to level, etc) or otherwise not major applications but in support of pending approvals or lifecycle commitments for marketed products (e.g.: meeting packages, responses as appropriate, Advertising and Promotion Submissions, routine labeling updates as appropriate, etc.) QC submission dossiers or parts of submission dossier output of low-to-moderate and moderate-to-high complexities as assigned. Other submission related requests could be assigned that are in support of general publishing but commensurate with role expectations. Role and Responsibilities: Utilize current electronic document management and publishing tools to prepare submission-ready Regulatory components and assemble, publish, and dispatch dossiers according to regulatory requirements for paper and electronic submissions with limited supervision Provide GRA component-level publishing support to ensure submission components conform to e-submission standards (e.g., templates, scanning, indexing) QC electronic and paper submissions to ensure compliance with company and agency requirements. Maintain effective interactions with all publishing contributors and responsible RA professionals, to ensure timely delivery of dossier components taking into consideration special requirements and needs; Maintain open and timely communication; Determine the scope of the electronic publishing requirements for the dossier Apply appropriate JRD document and dossier standards, including adherence to a pre-established submission content plan Participate in special projects and process improvement initiatives. Global Regulatory knowledge of product registration procedures covering IND, NDAs, CTAs, BLA, IMPDs, MAAs for various countries including regulated markets like US, EU, Canada and Australia-NZ. Support regulatory submissions publishing for EDMF, COS/CEP for Drug substance related filing and regulatory submissions publishing in MRP, DCP, CP and National filing for the EU or Support regulatory submissions publishing for Annual reports, Safety Reports, updates to DMF, labeling, stability and CMC sections for US. Reviews and maintains regulatory database comprising existing and new regulations pertaining to submission requirements for the region. Regular interaction with internal stakeholders and external stakeholders like Local Affiliates/ MC (Marketing Company) through emails & teleconference, through proper communication channels to ensure accuracy and completeness of submission and resolving issues as and when they arise. Escalates unresolved issues appropriately as per the agreed escalation process. Ensures that the quality and TAT targets defined are always met. Experience Required: Two or more years of experience in pharmaceutical industry submission publishing or related technical skills Minimum 1-year hands-on experience in working with Documentum and industry leading publishing tools, preferably Liquent Insight Publisher is required Experience with word processing, use/applications of templates, bookmarking, hyper-linking, Microsoft Office applications is required Familiarity with FDA or EU regulations & guidelines is preferred Practical understanding of evolving technologies in support of business area is preferred Skills Required: The candidate should possess strong attention to detail, exhibit excellent interpersonal communications (in English, both verbal & written), organizational, time management and follow-up skills. The candidate must also demonstrate personal initiative, responsibility, flexibility, the ability to work under limited supervision, and be able to handle multiple project assignments Managing own work: ability to prioritize, plan and organize multiple assignments, and to work under strict timelines Global Regulatory Knowledge; familiarity with regulatory resources (i.e., location, interpretation and application of global regulations and guidelines relating to regulatory affairs) Basic understanding of information management concepts and tools needed to support business area. Use various technical skills to resolve publishing/document preparation issues. Ability to demonstrate a solid command of the technical tools at the level required to perform job duties To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 369 b) For Position in Bangalore Search : Job Code # 370 c) For Position in Hyderabad Search : Job Code # 371

What you will do Let’s do this. Let’s change the world. In this vital role you will be responsible for designing, developing, and maintaining software applications and solutions in the Regulatory and Clinical Trial submission product team that meet business needs and ensuring the availability and performance of critical systems and applications. This role involves working closely with product managers, designers, and other engineers supporting applications like docuBridge Suite from Lorenz and Disclose from Citeline, developing scalable solutions, automating operations, monitoring system health, and responding to incidents to minimize downtime. The ideal candidate will have a strong background in regulatory submissions and clinical trials, along with innovative and transformational experience. Roles & Responsibilities: Take ownership of complex software projects from conception to deployment Manage software delivery scope, risk, and timeline Possesses strong rapid prototyping skills and can quickly translate concepts into working code Provide technical guidance and mentorship to junior developers Contribute to both front-end and back-end development using cloud technology Develop an innovative solution using generative AI technologies Conduct code reviews to ensure code quality and alignment to standard methodologies Create and maintain documentation on software architecture, design, deployment, disaster recovery, and operations Stay updated with the latest trends and advancements Work closely with the product team, business team, and other partners Design, develop, implement, and maintain applications, including configurations, custom reports, interfaces, and enhancements Analyze and understand the functional and technical requirements of applications, solutions and systems, and translate them into software architecture and design specifications Develop and implement unit tests, integration tests, and other testing strategies to ensure the quality of the software Work on integrating applications with other systems and platforms to ensure seamless data flow and functionality Provide ongoing support and maintenance for applications, ensuring that they operate smoothly and efficiently Design and implement systems and processes to improve the reliability, scalability, and performance of applications Develop and maintain monitoring tools and dashboards to track system health, performance, and availability Respond to and resolve incidents promptly, conducting root cause analysis and implementing preventive measures Implement and maintain security measures to protect systems from unauthorized access and other threats What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree OR Master’s degree and 4 to 6 years of Computer Science, IT or related field experience OR Bachelor’s degree and 6 to 8 years of Computer Science, IT or related field experience OR Diploma and 10 to 12 years of Computer Science, IT or related field experience Preferred Qualifications: Functional Skills: Must-Have Skills Have strong eye for business. Can demonstrate a deep understanding of pharma industry regulations and its compliance requirements Have excellent knowledge of submission publishing systems like Lorenz’s docuBridge application and Disclose from Citeline Have knowledge of ClinicalTrials.gov and EudraCT Have good knowledge of Regulatory Veeva Vault Demonstrated experience in managing technology initiatives and teams with a track record of successful innovation and fostering the development of talent. Exceptional collaboration, communication, must be flexible and able to manage multiple activities and priorities with minimal direction in a rapidly changing and demanding environment. Experience in applying technology standard process methodologiesScaled Agile (SAFe), ITIL, etc. Strong knowledge of information systems and network technologies Good-to-Have Skills: Strong knowledge of eCTD specification and highly regulated (GxP) systems Experience in a leadership role within a pharmaceutical or technology organization Extensive experience in the software development lifecycle of GxP Systems. Experience using and adoption of Scaled Agile Framework (SAFe) Strong analytical/critical-thinking and decision-making abilities. Ability to work effectively in a fast-paced, dynamic environment. Established business partnerships and IS governance practices involving senior business partners Broad working knowledge of key IS domains and layers Professional Certifications (please mention if the certification is preferred or mandatory for the role): ITIL (preferred) Scaled Agile Framework (SAFe) for Teams (preferred) Veeva Vault platform Certified (preferred) Soft Skills: Excellent analytical and solving skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills Shift Information: This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements. Equal opportunity statement Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com

Hi, We are hiring for leading ITES Company for Narrative Medical Writing Profile . Job Description Build and process submission dossiers of low-to-moderate complexity: Submission Dossiers that may be periodic (e.g.: safety reports) or minor amendments (e.g.: IND Amendment, DMF Amendment, CMC Update as appropriate to level, etc) or otherwise not major applications but in support of pending approvals or lifecycle commitments for marketed products (e.g.: meeting packages, responses as appropriate, Advertising and Promotion Submissions, routine labeling updates as appropriate, etc.). QC submission dossiers or parts of submission dossier output of low-to- moderate and moderate-to-high complexities as assigned. Other submission related requests could be assigned that are in support of general publishing but commensurate with role expectations. Role and Responsibilities: Utilize current electronic document management and publishing tools to prepare submission- ready Regulatory components and assemble, publish, and dispatch dossiers according to regulatory requirements for paper and electronic submissions with limited supervision Provide GRA component-level publishing support to ensure submission components conform to e-submission standards (e.g., templates, scanning, indexing) QC electronic and paper submissions to ensure compliance with company and agency requirements. Maintain effective interactions with all publishing contributors and responsible RA professionals, to ensure timely delivery of dossier components taking into consideration special requirements and needs; Maintain open and timely communication; and Determine the scope of the electronic publishing requirements for the dossier Apply appropriate JRD document and dossier standards, including adherence to a pre- established submission content plan Participate in special projects and process improvement initiatives. Global Regulatory knowledge of product registration procedures covering IND, NDAs, CTAs, BLA, IMPDs, MAAs for various countries including regulated markets like US, EU, Canada and Australia-NZ. Support regulatory submissions publishing for EDMF, COS/CEP for Drug substance related filing and regulatory submissions publishing in MRP, DCP, CP and National filing for the EU or Support regulatory submissions publishing for Annual reports, Safety Reports, updates to DMF, labeling, stability and CMC sections for US. Reviews and maintains regulatory database comprising existing and new regulations pertaining to submission requirements for the region. Regular interaction with internal stakeholders and external stakeholders like Local Affiliates/ MC (Marketing Company) through emails & teleconference, through proper communication channels to ensure accuracy and completeness of submission and resolving issues as and when they arise. Escalates unresolved issues appropriately as per the agreed escalation process. Ensures that the quality and TAT targets defined are always met. Experience Required: Two or more years of experience in pharmaceutical industry submission publishing or related technical skills Minimum 1-year hands-on experience in working with Documentum and industry leading publishing tools, preferably Liquent Insight Publisher is required Experience with word processing, use/applications of templates, bookmarking, hyper-linking, Microsoft Office applications is required Familiarity with FDA or EU regulations & guidelines is preferred Practical understanding of evolving technologies in support of business area is preferred Skills Required: The candidate should possess strong attention to detail, exhibit excellent interpersonal communications (in English, both verbal & written), organizational, time management and follow-up skills. The candidate must also demonstrate personal initiative, responsibility, flexibility, the ability to work under limited supervision, and be able to handle multiple project assignments Managing own work: ability to prioritize, plan and organize multiple assignments, and to work under strict timelines Global Regulatory Knowledge; familiarity with regulatory resources (i.e., location, interpretation and application of global regulations and guidelines relating to regulatory affairs) Basic understanding of information management concepts and tools needed to support business area. Use various technical skills to resolve publishing/document preparation issues. Ability to demonstrate a solid command of the technical tools at the level required to perform job duties Problem solving skills Management of team Knowledge of business principles. Key Skills: a) Grad or PG in Nursing, Pharmacy or Life Sciences b) 2or more years of experience in pharmaceutical industry submission publishing or related technical skills c) Familiarity with FDA or EU regulations & guidelines To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Noida Search : Copy and Paste the link below https://outpace.in/job/regulatory-submissions-publisher-4/