47 Cdsco Jobs

Responsible for supplier audit planning, scheduling, and conduct supplier audits. Responsible for vendor/ supplier quality and management issues. Responsible for implementation of ISO 13485 requirements Responsible for formulating, document, and maintain quality standards and ongoing quality objectives. -Analysis of raw material, In-process samples, and finished product. -Auditing OEM and verify the process control and quality, suggest changes if required to improve quality. -Responsible to escalate technical issues to the design team and Providing product feedback and customer suggestions to the R&D and Product Management team, also tracking the continuous improvement of the products. -Resp...

Role & responsibilities: Outline the day-to-day responsibilities for this role. Preferred candidate profile: Specify required role expertise, previous job experience, or relevant certifications.

Position Sr Manager – Regulatory & Quality Assurance Experience – Min 10yrs Qualification – Graduate or Post Graduate (B.SC./M.Sc./M. Pharma) in Life Science / Chemistry. Location – Dhaulpur Salary – Negotiable In case interested kindly share your resume to hrcorporate@swearhealthcare.com OR Whats app – 8527517739 Roles & Responsibilities Responsible for implementation of Quality Management System as per ISO 13485:2016. Knowledge of BIS-ISI product registration & renewals. Understanding of UDI labeling requirements, UDI processes & Product Labeling to meet the GS1, ISO 15223-1, EN 62366, ISO 20417, and EU MDR 2017/745 requirements, etc. Knowledge of barcode symbology (GS1 barcodes, & QR code...

Role & responsibilities Responsible for ensuring and carrying out tasks in accordance with FDCA, CDSCO and Prohibition Excise guidelines. Responsible for preparing the ACDF application, i.e. CoPP, renewal and new manufacturing licences. Responsible for WHO GMP, Additional Product Permission, Tender Certificate, Test License Technical person approval Responsible for preparing wholesale license, loan license, audit, and inspection reports. Responsible for preparing IT application at CDSCO i.e. Test License, Form 10, From 11, Import & Export NOC Responsible to ensure and prepare renewal of licence for prohibition and excise. Also took necessary approval for Naukarnama and do return submission a...

Regulatory Liaison: Sound knowledge of schedule-M and all approval required for API and CDMO organisation. Act as the main interface with CDSCO, DCA, and other regulatory state authorities. Oversee applications (all types CT-11, 15, Form-25, 29, WC)

Job Title: Regulatory Affairs Specialist Med/Pharma (Female) Location: Remote Position Overview: We are seeking an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring compliance with applicable regulations (FDA, EMA, CDSCO, MHRA, ISO 13485, ICH guidelines). The ideal candidate will have a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and commercialization. Key Responsibilities: Prepared, reviewed...

Company Name: Exemed Pharmaceuticals Designation - Drug Regulatory Affairs -Officer/Sr Officer Location - Vadodara ( Corporate Office) Market: Domestic Primary Job Descriptions Having knowledge of SUGAM portal and CDSCO website Submission for Mfg. & Mkt. Applications [CT21/CT-18] for IND, New Drug, Subsequent New Drug, FDC. Application of CT-05 / CT- 04 Application of CT-10 / 12/ 13 Application of import Licenses [CT-16/ Form 12/Form 08] Knowledge of IPC submissions Form 29 application Preparation of presentation for Subject Expert committee (SEC) Product Lifecycle & Management Additionally, should be well verse with Preparation of Module 4 & 5 Nonclinical & Clinical data Preparation of Pack...

Role & responsibilities Responsible for ensuring and carrying out tasks in accordance with FDCA, CDSCO and Prohibition Excise guidelines. Responsible for preparing the ACDF application, i.e. CoPP, renewal and new manufacturing licences. Responsible for WHO GMP, Additional Product Permission, Tender Certificate, Test License Technical person approval Responsible for preparing wholesale license, loan license, audit, and inspection reports. Responsible for preparing IT application at CDSCO i.e. Test License, Form 10, From 11, Import & Export NOC Responsible to ensure and prepare renewal of licence for prohibition and excise. Also took necessary approval for Naukarnama and do return submission a...

We are seeking a highly skilled and detail-oriented Regulatory Affairs Executive / Senior Executive to join our dynamic team. The ideal candidate will have hands-on experience in applying for and managing regulatory licenses required for the import of raw materials and manufacturing of pharmaceutical, nutraceutical, and Ayurveda products. The role demands expertise in navigating Indian regulatory frameworks, including CDSCO, FSSAI, AYUSH , and obtaining Dual NOCs , Import Licenses , and product registrations . Key Responsibilities: Import Licensing & Raw Material Compliance Apply for and manage raw material import licenses through CDSCO or other relevant bodies. Coordinate with suppliers, fr...

Role & responsibilities " Responsible for local regulatory activities (driven by local or corporate initiatives) and operations with respect to new product registration, new indications and life cycle management. The individual will execute all the regulatory activities related to assigned portfolio for India and neighboring countries (Sri Lanka, Bangladesh & Nepal) as per Business needs. To act in compliance with country policies and practices to reduce companys exposure to Regulatory risks. Regular Follow up with officials in Health Authorities and to keep updated on changes to local regulatory environment/trends and impact of the regulatory requirements changes to the local business oppor...

As a Product Compliance & Quality Specialist in the Hygiene & Personal Care industry, you will be responsible for leading compliance, product claims, and quality systems for impactful categories including Handwash, Sanitizers, Toilet Cleaners, Detergents, Baby Products, Cosmetics, AYUSH, Medical Devices, and Wellness Products. Your role will involve ensuring compliance with regulatory bodies such as BIS, LM, CDSCO, AYUSH, and EPR rules. You will define test protocols, verify claims, drive audits, manage product documentation, artwork, risk assessments, and CAPA processes. Collaboration with cross-functional teams including R&D, Legal, Marketing, and Vendors will be key to success in this rol...

Alkem Laboratories Limited is an Indian multinational pharmaceutical company based in Mumbai, specializing in the manufacturing and distribution of pharmaceutical generics, formulations, and nutraceuticals across India and over 50 countries globally. Renowned for its top-tier pharmaceutical brands like Clavam, Pan, Pan-D, and Taxim-O, Alkem has consistently secured a position among India's top five pharmaceutical companies. As the IT Business Partner for SCM & Logistics at Alkem, your primary role is to serve as a strategic technology advisor, ensuring that IT solutions are aligned with the company's business objectives for the Supply Chain and Logistics functions. Your responsibilities incl...

Responsibilities: * Prepare CDSCO dossiers & manage vendors * Conduct clinical research, formfilling expertise required * Ensure compliance with regulatory standards * Manage SUGAM portal submissions have experience in indian regulatory

As a Manufacturing Supervisor for Active Pharmaceutical Ingredients (API), you will be responsible for overseeing and enhancing the production processes to ensure top-notch quality, operational efficiency, and compliance with regulatory standards. Your main focus will be on driving operational excellence and supporting scale-up activities within a dynamic production setting. Your key responsibilities will include managing the entire API production process, starting from handling raw materials to delivering the final output. It will be crucial for you to maintain strict adherence to cGMP, EHS, and various regulatory norms such as ICH and CDSCO. Collaboration with R&D, QA/QC, and engineering t...

Company Name: Exemed Pharmaceuticals Designation - Drug Regulatory Affairs -Officer/Sr Officer Location - Vadodara ( Corporate Office) Market: Domestic Primary Job Descriptions Having knowledge of SUGAM portal and CDSCO website Submission for Mfg. & Mkt. Applications [CT21/CT-18] for IND, New Drug, Subsequent New Drug, FDC. Application of CT-05 / CT- 04 Application of CT-10 / 12/ 13 Application of import Licenses [CT-16/ Form 12/Form 08] Knowledge of IPC submissions Form 29 application Preparation of presentation for Subject Expert committee (SEC) Product Lifecycle & Management Additionally, should be well verse with Preparation of Module 4 & 5 Nonclinical & Clinical data Preparation of Pack...

Responsibilities: * Manage regulatory affairs portfolio from pre-clinical to post-market. * Ensure compliance with FDA, CDSCO & vendor management. * Collaborate on product development life cycle.

Are you passionate about driving clinical quality and compliance Do you have a proven track record in clinical operations and a knack for innovation and process improvement If you're ready to take on a leadership role that makes a real impact, we invite you to explore this exciting opportunity, apply today for a life-changing career! As the Head of Clinical Operational Excellence, you will play a pivotal role in ensuring clinical quality, compliance, and operational excellence. Your key responsibilities will include performing risk assessments and trend analyses to proactively address clinical quality risks, ensuring audit and inspection readiness including CAPA documentation and stakeholder...

Role & responsibilities Architect and implement a lean, auditready ISO13485:2016 Quality Management System and drive certification. Own all designcontrol documentation (SRS, DHF, Risk Management File, DMR, Technical File, etc.) in collaboration with engineering teams. Define and execute regulatory strategies: first CDSCO (ClassII/III), then FDA 510(k), and EU MDR CE Mark. Prepare, review, and submit regulatory dossiers; interact with authorities and notified bodies. Plan and conduct internal audits, manage CAPA investigations, and lead continuousimprovement initiatives. Qualify and monitor suppliers/CMOs; establish incoming and inprocess quality controls and batchrelease records. Train cross...

As a Regulatory Affairs Associate, you will be required to hold a Master's Degree in M. Pharm or M. Sc. with a specialization in Pharmaceutics, Industrial Pharmacy, Pharmaceutical Chemistry, Analytical Chemistry, Chemistry, Biochemistry, or Microbiology. A minimum of 2 to 6 years of hands-on experience in R&D within Manufacturing or Import companies, specifically in MNCs and Generics, is essential for this role. Proficiency in CDSCO and Central Licensing Agency - New Delhi (SUGAM) skills, including Agency Liaison, is a priority as applications lacking these skills will not be considered. Your responsibilities will include understanding new client requirements, scope, deliverables, and timeli...

You will be responsible for reviewing and conducting chemical testing of raw materials, finished products, cosmetics, Ayurveda, Sidha & Unani products. You will need to accurately enter the test results into the LIMS software. Additionally, you will be required to handle instruments like HPLC, GC, FTIR, Dissolution, etc. Technical documentation in compliance with FDA, CDSCO & Ayush standards for audits will also be part of your responsibilities. The position is based in Gurugram and requires a minimum qualification of B.Pharma, M.Pharma, MSc. Chemistry or a related field. The ideal candidate should have 2 to 15 years of relevant experience.,

Role & responsibilities Dossier Preparation in CTD/ACTD/Country Specific Formats 2. Re-registration and Renewal Application 3. Variation Application 4. Queries Handling 5. DMF Activity 6. Artwork Review (Carton/Foil/Label/Insert/Shipper) 7. Pack Insert Preparation as per Country Guideline 8. Documents and Sample Collection Activity from F&D, QA, QC and Store department for registration requirement. 9. Documents Review Knowledge: Pharmaceutical Development Report, Process Validation Protocol & Report, Excipients Specifications/MOA, Finished Product Specification/MOA, Packing Material Specification/MOA, COA, Stability Study Protocol & Report, MFR, BMR, BPR, Clinical/Non Clinical Literature Sea...

KEY RESPONSIBILITIES: Delegating and directing service tasks, monitoring the progress of current projects, and managing service team members to ensure the team's objectives and sales goals are met. Handling customer complaints or concerns quickly and professionally to maintain good customer relationships and ensure repeat customers. Assisting with or performing administrative tasks, such as managing and updating invoices, processing new orders, and tracking inventory. Setting up and maintaining a service desk and evaluating its efficiency. Resolving service desk problems and improving service methods to increase the service desk's productivity and customer service. Monitoring department issu...

Job Title: Senior Regulatory Affairs Team Lead Medical Devices Location: Chennai, India Department: Regulatory Affairs Experience Required: Minimum 5 years Reports To: Head of Regulatory Affairs / Director of Quality & Regulatory Job Summary: We are seeking a highly skilled and experienced Senior Regulatory Affairs Team Lead to manage and lead our regulatory submissions and strategy for medical devices in India. The ideal candidate will have a deep understanding of the regulatory framework governed by CDSCO (Central Drugs Standard Control Organization) and proven experience in successfully obtaining approvals for medical devices. This role requires both strategic oversight and hands-on execu...

Job Purpose: Maintain compliance to Quality Management System to deliver consistent quality medical devices to fulfil future strategy of Cipla. To Lead and establish Quality Management System for medical devices as per EU Regulatory requirements, CDSCO and ISO 13485 requirements and develop and implement documentation such as SOPs, Quality manual etc. to define the framework. Monitor effective implementation of Quality System across function and appraise Management Representative. Responsible for monitoring metrics/KPI for medical devices starting from design, manufacturing, postproduction. Compile data for management review meetings. Responsible for coordinating with cross functional team f...

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...