454 Regulatory Submissions Jobs - Page 2

Role Overview: As a Medical Writer at our company, you will play a crucial role in creating high-quality documents for various medical and scientific projects. Your expertise in scientific writing and in-depth knowledge of medical and healthcare concepts will contribute to the success of clinical trials, regulatory submissions, publications, and other scientific materials. You will collaborate closely with cross-functional teams to ensure the accuracy and compliance of all written documents. Key Responsibilities: - Write and edit various medical and scientific documents such as clinical study reports, regulatory submissions, and research papers. - Ensure that all documents adhere to regulato...

Job Description You will be taking on a full-time on-site Sr Manager Drug Regulatory Affairs role in Chandigarh. Your main responsibilities will include ensuring regulatory compliance, managing regulatory requirements, overseeing regulatory affairs, handling regulatory submissions, and maintaining the quality system. Key Responsibilities - Ensure regulatory compliance - Manage regulatory requirements - Oversee regulatory affairs - Handle regulatory submissions - Maintain the quality system Qualifications - Regulatory Compliance and Quality System management experience - Understanding and implementing Regulatory Requirements experience - Proficiency in managing Regulatory Affairs and handling...

As a highly skilled and motivated analytical scientist, your role at our client's vaccine innovation company will involve leading efforts for the analytical development and method qualification within the Vaccine Product Development organization. Your primary responsibilities will include: - Providing strategic, tactical, and technical leadership in the development of analytical methods supporting protein manufacturing processes. - Collaborating with the protein development team to determine the best methods for measuring quality attributes. - Developing the method qualification approach for assays used in process characterization. - Offering technical direction, mentorship, and coaching to ...

As a selected intern at Noccarc Robotics, your responsibilities will involve: - Conducting clinical validation tests of ICU ventilators, patient monitors, and other critical care devices in hospital and laboratory settings. Collaborating closely with intensivists, respiratory therapists, and ICU staff to evaluate product performance. - Designing and implementing ex-vivo and in-clinic testing protocols to ensure device functionality, accuracy, and safety. - Collecting, analyzing, and interpreting clinical data to generate insights for product improvements. - Documenting findings, preparing validation reports, and contributing to regulatory submissions. - Identifying and troubleshooting device...

As a Statistical Programmer in our company, your role will involve providing statistical input to the design, analysis, reporting, and interpretation of clinical studies. You will also contribute to publications. Your responsibilities will include: - Utilizing SAS or other software to develop custom programming code for generating tables, data listings, graphs, and derived datasets as specified in the protocol or statistical analysis plan. - Ensuring that all outputs meet quality standards and project requirements. - Performing validation programming and collaborating with other Programmers, Biostatisticians, and project team members to resolve any discrepancies or findings. - Keeping the pr...

As a Senior Medical Writer at MS Clinical Research Pvt Ltd, you will be responsible for creating high-quality, scientifically accurate medical documents to support clinical trial activities and regulatory submissions. Your role will involve preparing and reviewing clinical study protocols, reports, and other trial documents in compliance with regulatory guidelines and industry standards. Additionally, you will collaborate with cross-functional teams, interpret clinical trial data, assist in regulatory submissions, and contribute to project planning and timelines. Key Responsibilities: - Prepare and review clinical study protocols, reports, and other trial documents following regulatory guide...

Job Description Join our dynamic Corporate Functions team, where we support diverse areas like finance, risk, and marketing to promote success for our businesses, clients, and employees. As part of Global Supplier Services, you'll engage in sourcing, third-party oversight, and supplier relationship management. The CTPO team at JPMorgan Chase ensures third parties meet our high standards in client service, quality, and compliance. Be a part of the CTPO - LEORA team, a key player in managing Supplier Risk Reporting and Inventory submission, crucial for effective Outsourcing Governance and regulatory compliance. As a LEORA Analyst within the CTPO - LEORA team, you will report functionally to th...

Job Title Manager 2/1 R&D Biotechnology Business Unit R&D1 Regulatory Affairs Job Grade G11A/G10 Location Baroda At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine As you enter the Sun Pharma world, you'll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other's journeys. Key Responsibilities Develop and implement phase-appropriate ana...

Position Overview In Scope of Position based Promotions (INTERNAL only) Job Title: Enterprise & Treasury Risk Management / Capital Risk Management & recovery planning, AVP Location: Mumbai, India Role Description Treasury Risk Management (TRM), within the Chief Risk Office function, provides a holistic oversight of financial risks associated with Treasury activities. These include inter-related risks such as liquidity & funding risk, capital risk, structural interest rate and FX risks. Additional responsibilities include the submission of the ICAAP and the Group Recovery Plan, Resolution planning, 2LoD contribution to the ILAAP, and the review and challenge of the Funds Transfer Pricing fram...

As a Lead Scientist in Hosur, your role involves developing diagnostic assays such as nucleic acid-based, immunoassays, and enzymatic tests. You will be responsible for designing and executing experiments to support assay development and validation in compliance with CLIA/CAP/ISO standards. Your duties will also include analyzing and interpreting complex data sets using statistical and bioinformatics tools, collaborating with clinical teams to optimize assays for diagnostic applications, and preparing technical reports, SOPs, validation documentation, and regulatory submissions. In case of assay performance issues, you will troubleshoot and implement corrective actions. Additionally, mentori...

As an intern at Noccarc Robotics, your day-to-day responsibilities will involve conducting clinical validation tests of ICU ventilators, patient monitors, and other critical care devices in hospital and laboratory settings. You will collaborate with intensivists, respiratory therapists, and ICU staff to assess product performance. Additionally, you will be responsible for designing and executing ex-vivo and in-clinic testing protocols to validate device functionality, accuracy, and safety. - Conduct clinical validation tests of ICU ventilators, patient monitors, and other critical care devices - Collaborate with intensivists, respiratory therapists, and ICU staff - Design and execute testing...

As a Biostatistician, you will play a crucial role in contributing to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions. You will collaborate with various stakeholders such as the GBDS Biostatistics Lead, medical monitor, protocol manager, data manager, PK scientist, and other members of the study/indication team. Your responsibilities will include: - Driving the selection of optimal study designs, data collection methods, and analytic approaches. - Providing strategic and scientific input at the indication/protocol/integrated analysis level to enhance the understanding of the asset being studied and improve developmen...

Roles and Responsibility Manage regulatory affairs for pharmaceutical products in the European and Canadian markets. Develop and implement regulatory strategies to ensure compliance with relevant laws and regulations. Collaborate with cross-functional teams to prepare and submit regulatory documents. Conduct thorough reviews of regulatory submissions to ensure accuracy and completeness. Maintain up-to-date knowledge of changing regulatory requirements and guidelines. Provide training and support to internal stakeholders on regulatory matters. Disclaimer: This job description has been sourced from a public domain and may have been modified by Naukri.com to improve clarity for our users. We en...

Role Overview: As the Statistical Science Director at the organization, you will be a key leader in advancing the application of statistical science within the pharmaceutical industry. Your expertise in statistical methodology, project design, delivery, and interpretation will be crucial in guiding various stages of product development. Your responsibilities will include leading statistical strategy for projects, contributing to regulatory submissions, and influencing internal governance decisions. The ideal candidate for this role is an externally recognized expert in statistical methods with the ability to guide complex analyses and mentor junior staff. Strong cross-functional collaboratio...

Role Overview: As the Cybersecurity Lead for Risk & Compliance IT, you play a crucial role in supporting the Chief Information Security Officer (CISO) for Enterprise Technology as part of the 1st Line of Defence (1LoD). Your main focus will be on strengthening cybersecurity governance, enabling risk-based decision-making, ensuring compliance, and supporting remediation initiatives for the Risk & Compliance IT landscape. Additionally, you will provide cybersecurity oversight across various areas of Enterprise Technology and support broader CTO CISO team initiatives. The ideal candidate for this role will have deep expertise in cybersecurity risk management, governance, regulatory compliance, ...

Role Overview: As a candidate for this position, you will be responsible for developing, validating, and transferring analytical methods for raw materials, intermediates, and finished products in compliance with regulatory guidelines such as ICH, USP, EP, JP, etc. You will utilize techniques including HPLC, UPLC, GC, MS, FTIR, UV-Vis, and dissolution testing for method development. Your role will also involve supporting formulation development by providing analytical data for stability, compatibility, and process optimization studies. Additionally, you will troubleshoot analytical methods and instrumentation to ensure data integrity and reliability. Conducting forced degradation and stabilit...

At EY, we're all in to shape your future with confidence. We'll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and help to build a better working world. ICAAP and ILAAP Senior Consultant FS Risk Consulting - MENA About The Job At EY, you'll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we're counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. I CAAP & ILAAP Senior Consultant, FS R...

Responsibilities Responsible and review of DCGI applications for BE-NOC, T-License and working standard Import license. Responsible for query reply to all DCGI related matters like, BE-NOC, Import License and working standard Import license. Responsible for feasibility of all molecules as per requirements of DCGI regulatory authority. Responsible and review of DCGI Notification for IEC doc submission, Typo Error and minor /amendment changes application. Responsible and Review of Test License Renewal Applications. Responsible for quarterly filling of precursor molecule to NCB, Mumbai. Responsible for submitting quarterly return of NDPS substances to CBN and state FDA. Preparation and Review o...

Be responsible for managing regulatory submissions in terms of collection of data, review of site variations Be up-to-date with Guidance and MHRA & EU Regulations and provide assistance in evaluating proposed changes and deciding strategy, BE study queries Post approval change management To assist in thorough interpreting of RFIs, and outlining plan of action to respond to deficiencies To provide support/assistance to UK RA team by coordinating with suppliers/CMOs on Regulatory matters

RA Profile (EU Market Filing and Query & Response) Department: Regulatory Affairs Reporting to: Senior Director Global Regulatory Affairs Job Location: Bangalore Industry: Pharmaceuticals Key Responsibilities Regulatory submissions to the EU Market and Query Response subsequently comply with applicable regulatory requirements Compile and review all documents required in line with the relevant guidelines. Coordinate with relevant departments and prepare submissions. Perform detailed regulatory review and assessment of all documents, gather required data as needed to develop/finalise the documents, coordinate and prepare submissions Review technical reports, summary documents and change contro...

Senior Compliance Analyst India At Optiver, you'll find an environment built on collaboration, curiosity, and continuous improvement. As a leading technology-driven market maker, we thrive on solving complex challenges that power the world's financial markets. Our Compliance team plays a crucial role in ensuring that we operate with integrity, within regulatory frameworks, and in line with Optiver's risk appetite. That's where you come in. In this role, you will be part of the India Compliance team, working closely with the India Head of Compliance to support day-to-day compliance operations, regulatory obligations, and risk management processes. You will also collaborate with regional teams...

. Job Title: Manager 2/1 – R&D Biotechnology Business Unit: R&D1 Regulatory Affairs Job Grade G11A/G10 Location Baroda At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” Key Responsibilities: Develop and implement pha...

Develop and execute regulatory strategies for Class I, II, and III medical devices in compliance with US FDA (21 CFR Part 820) and EU MDR (2017/745). Prepare, review, and submit regulatory submissions including 510(k), PMA, Technical Documentation, and Design Dossiers. Global regulatory experience or knowledge is added advantage. Collaborate with cross-functional teams including R&D, Quality, Clinical, and Manufacturing to ensure regulatory compliance throughout product lifecycle. Assess the regulatory impact of product and process changes and ensure proper documentation and notification. Support internal and external audits, including FDA inspections and Notified Body audits, ensuring readi...

Prepare & review dossiers Manage product registrations/submissions Ensure regulatory & documentation compliance Coordinate with QA/QC/R&D teams Review artworks/labels Support audits & authority queries Call on- 9662266641/9662266691

Role & Responsibilities To prepare dossiers for product registration and renewal as per the scheduled time in African and Middle East countries in Regional as well as CTD formats as per the requirements for registration purpose. Variation filing of the products considering all the changes in Finished product. Local FDA activity as and when required. CDSCO activity as and when required. To check artworks for regulated and semi regulated countries for defined countries. To co-ordinate for documents and samples for regulatory submissions with manufacturing locations - LL & TP. Handling of queries pertaining to regulatory submissions from various regulatory authorities. Maintain and update regul...