187 Regulatory Submissions Jobs - Page 8

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/

Role & responsibilities Asst Manager / Sr. Executive - Regulatory DRA DEPT- Europe Market @ Pharma Formulation -PUNE City. Person will be responsible for DRA function for Pharma Formulation for Advanced Markets / EU The candidate should be conversant with preparing dossiers for Finished Formulations for EU. Preferred candidate profile Honest, Hard Working. Growth Mindset (Important). Good Communications Skills. Relevant Experience in Pharma Only Candidate with Relevant Experience may apply. We also encourage rightful candidates to write directly to us to "info@vekocare.com" with a proper covering note.

We are hiring an International Regulatory Affairs Executive/Manager with expertise in regulatory documentation, CTD dossiers & query handling. Immediate joiners preferred. Candidates with 1+ year experience may also apply. Join our growing team!

Expertise in API / Formulation regulatory compliance across EU/ROW regions Sound knowledge of Drug Substance control strategies Familiarity with global regulations: ICH, FDA, EMA, USFDA etc Skilled in responding to Ministry of Health (MoH) queries Required Candidate profile M. Pharma / B. Pharma / M.Sc / B.Sc with 7 to 15 Years Experience Deep Knowledge of Regulatory Affairs Compliance And Procedures Must be able to work independently And Head Team of junior Officers

Audit & Risk Management To support in the preparation, implementation and monitoring of the SOP's related to Health safety & Environment practices across all AIS Plants. Standardization & horizontal deployment of best practices. Plan and coordinate internal and third-party EHS audits across all units. Track, review, and follow up on audit findings, incident investigations, and corrective actions. Support plants in conducting risk assessments and HIRA/JSA exercises. 1. No of non compliances in internal/external audits 2. Audit score 3. No of Trainings EHS Data Management & Reporting: Consolidate and analyze EHS KPIs from all units. Prepare monthly/quarterly corporate dashboards and presentations for management and regulatory submissions Timeline for collection, compilation and circulation of data Project Support to improve Fare Safety Infrastructure Participate in new project evaluations and support EHS-related design reviews (e.g., fire safety, environmental clearances). Assist in vendor evaluation from an EHS perspective.Monitor to Annual Safety improvement plan Statutory & Legal Compliances.To check and fulfil the legal and statutory compliance requirement under various Environment , Health and Safety Acts. Should have good knowledge about ESG & plastic waste 1) Compliance plan vs. actual 2) Delay in renewal of agreement & License 3) Number of NC in external & internal auditTrainingTo provide training periodically on environmental aspects Number of trainings

Job Purpose: To lead and support regulatory operations for agrochemical products across the Asia Pacific region, ensuring compliance with local regulations, facilitating product registrations, and enabling market access. This role is critical in aligning regional regulatory strategies with global business objectives. Regulatory Compliance & Strategy Monitor and interpret regulatory requirements for agrochemicals (e.g., pesticides, herbicides, fertilizers) across APAC countries. Develop and implement regulatory strategies to support product launches and lifecycle management. Liaise with regulatory authorities and industry bodies to stay ahead of regulatory changes and advocate for science-based policies. Product Registration & Documentation Prepare and submit registration dossiers for new and existing agrochemical products, including active ingredients and formulations. Ensure timely renewals, amendments, and compliance with country-specific data requirements (e.g., toxicology, efficacy, environmental impact). Maintain accurate records of regulatory submissions, approvals, and correspondence. Operational Excellence Standardize regulatory processes across APAC affiliates to improve efficiency and compliance. Support digital transformation initiatives such as Regulatory Information Management Systems (RIMS). Collaborate with internal teams (R&D, Legal, Marketing) to ensure alignment on regulatory deliverables. Stakeholder Collaboration Act as a regulatory point of contact for internal and external stakeholders, including distributors and government agencies. Provide training and guidance to local teams on regulatory procedures and documentation standards. Support crisis management and product stewardship initiatives related to regulatory issues.

Review and analyse information from the general ledger and other accounting records to ensure accuracy and completeness, taking corrective action as necessary. Manage compliance with R2R accounting standards across the group. Identify gaps in finance processes that may have been overlooked, mitigating potential material reporting issues. Challenge and hold senior finance managers and staff accountable in instances where inappropriate accounting is detected. Lead and support the team, providing guidance to help members achieve established goals and KPIs. Consistently adhere to all deadlines. Prepare and review balance sheet analyses and reconciliations, review profit and loss statements, and implement required adjustments. Support the Corporate function in the consolidation and reporting of BU/Division financial results. Has finance responsibility for fixing any issues with SAP by working with the FICO (IT) team Perform general accounting tasks and participate in month-end close activities. Generate month-end reports, prepare entity-level management accounts, and liaise with business units to obtain variance commentary. Support group financial report preparation. Advise the business on effective project structuring to optimise on-system management reporting. Address audit enquiries and investigations as required. Conduct fixed asset processing to facilitate reporting and capital expenditure management. Roles may evolve to include support for business planning and forecasting initiatives. Develop and maintain strong professional relationships with colleagues, business staff, and management, building trust and deepening business understanding. Demonstrate proactivity in issue resolution, provide feedback, and contribute ideas for continuous improvement. Participate in relevant training activities and ongoing professional development. Maintain confidentiality and strictly comply with data protection regulations. Complete regulatory submissions and act as a point of contact for regulatory bodies.

We are seeking a highly skilled and experienced professional for the role of Design Quality Assurance (DQA) in Pune. The ideal candidate will have a strong background in quality management systems, regulatory compliance for medical devices, and hands-on experience with statistical tools and project management. This role is critical in ensuring product quality and regulatory adherence for Class II and III medical devices. Key Responsibilities: Ensure compliance with ISO 13485 , ISO 14971 , and other relevant quality standards. Oversee design assurance, design control, verification, and validation activities. Support regulatory submissions and audits for Class II and III medical devices. Utilize statistical tools (e.g., MINITAB) for data analysis and quality improvement. Apply Geometric Dimensioning and Tolerancing (GD&T) in product design and evaluation. Manage projects using tools like MS Project and ensure timely delivery. Collaborate with cross-functional teams to drive quality initiatives. Primary Skills (Mandatory): Professional training/certification in Quality Management Systems (ISO 13485, ISO 14971). Strong understanding of medical device regulatory requirements . Experience with design assurance/control , verification , and validation . Proficiency in MS Project and statistical tools like MINITAB . Knowledge of GD&T principles. CQE certification or equivalent training/experience is preferred. Secondary Skills (Good to Have): Exposure to emerging technologies and current industry practices . Ability to learn quickly and work independently with minimal supervision. Strong verbal and written communication skills. Qualification: Bachelors or higher degree in Biomedical Engineering or Pharmaceutical Sciences Works in the area of Software Engineering, which encompasses the development, maintenance and optimization of software solutions/applications. 1. Applies scientific methods to analyse and solve software engineering problems. 2. He/she is responsible for the development and application of software engineering practice and knowledge, in research, design, development and maintenance. 3. His/her work requires the exercise of original thought and judgement and the ability to supervise the technical and administrative work of other software engineers. 4. The software engineer builds skills and expertise of his/her software engineering discipline to reach standard software engineer skills expectations for the applicable role, as defined in Professional Communities. 5. The software engineer collaborates and acts as team player with other software engineers and stakeholders.

We are seeking a highly skilled and experienced professional for the role of Design Quality Assurance (DQA) in Pune. The ideal candidate will have a strong background in quality management systems, regulatory compliance for medical devices, and hands-on experience with statistical tools and project management. This role is critical in ensuring product quality and regulatory adherence for Class II and III medical devices. Key Responsibilities: Ensure compliance with ISO 13485 , ISO 14971 , and other relevant quality standards. Oversee design assurance, design control, verification, and validation activities. Support regulatory submissions and audits for Class II and III medical devices. Utilize statistical tools (e.g., MINITAB) for data analysis and quality improvement. Apply Geometric Dimensioning and Tolerancing (GD&T) in product design and evaluation. Manage projects using tools like MS Project and ensure timely delivery. Collaborate with cross-functional teams to drive quality initiatives. Primary Skills (Mandatory): Professional training/certification in Quality Management Systems (ISO 13485, ISO 14971). Strong understanding of medical device regulatory requirements . Experience with design assurance/control , verification , and validation . Proficiency in MS Project and statistical tools like MINITAB . Knowledge of GD&T principles. CQE certification or equivalent training/experience is preferred. Secondary Skills (Good to Have): Exposure to emerging technologies and current industry practices . Ability to learn quickly and work independently with minimal supervision. Strong verbal and written communication skills. Qualification: Bachelors or higher degree in Biomedical Engineering or Pharmaceutical Sciences Works in the area of Software Engineering, which encompasses the development, maintenance and optimization of software solutions/applications. 1. Applies scientific methods to analyse and solve software engineering problems. 2. He/she is responsible for the development and application of software engineering practice and knowledge, in research, design, development and maintenance. 3. His/her work requires the exercise of original thought and judgement and the ability to supervise the technical and administrative work of other software engineers. 4. The software engineer builds skills and expertise of his/her software engineering discipline to reach standard software engineer skills expectations for the applicable role, as defined in Professional Communities. 5. The software engineer collaborates and acts as team player with other software engineers and stakeholders.

Responsibilities: Operate, monitor, and optimize Effluent Treatment Plant (ETP) and Sewage Treatment Plant (STP) processes to ensure compliance with discharge norms. Ensure environmental compliance under CPCB, SPCB, MoEFCC, and other regulatory bodies. Prepare and maintain all necessary records related to Hazardous Waste Management, Water/Air Consent, and Environmental Audits. Manage liaisoning activities with government authorities for timely approvals, renewals, and inspections (e.g., Pollution Control Board, Factories Department, etc.). Lead initiatives related to sustainability, energy saving, and pollution prevention. Conduct environmental impact assessments (EIA) and periodic internal audits. Prepare and submit monthly/quarterly reports on environmental performance. Train staff on environmental awareness and best practices in ETP operations. Strong knowledge of local and national environmental regulations. Proficiency in preparing environmental documentation and regulatory submissions. Required Skills: Logical thinking. Organizing Team Player Good communication and problem-solving skills. Required Qualification:- B.Sc/M.Sc/B.E/B.Tech - Environment

Tracking of Regulatory emails and ensuring revert has been provided to Exchange Insider Trading Regulation Approvals Advertisement approvals Regulatory Submissions - Exchanges and Depositories ================================================= Educational Qualifications: Graduate/Post Graduate Experience: 5 to 6 year experience in Broking firm Domain Knowledge: Broking Industry, SEBI Regulations NISM IIIA to be cleared mandatorily