168 Regulatory Documentation Jobs

Senior Medical Writer Experience: 3 - 7 Years Exp Salary : Competitive Preferred Notice Period : Within 30 Days Opportunity Type: Onsite (Ahmedabad) Placement Type: Permanent (*Note: This is a requirement for one of Uplers' Clients) Must have skills required : CRO, writing scientific/regulatory/ clinical documents, MS Office suite Tatvacare (One of Uplers' Clients) is Looking for: Senior Medical Writer who is passionate about their work, eager to learn and grow, and who is committed to delivering exceptional results. If you are a team player, with a positive attitude and a desire to make a difference, then we want to hear from you. Role Overview Description Company Overview Tatvacare is a cu...

Senior Medical Writer Experience: 3 - 7 Years Exp Salary : Competitive Preferred Notice Period : Within 30 Days Opportunity Type: Onsite (Ahmedabad) Placement Type: Permanent (*Note: This is a requirement for one of Uplers' Clients) Must have skills required : CRO, writing scientific/regulatory/ clinical documents, MS Office suite Tatvacare (One of Uplers' Clients) is Looking for: Senior Medical Writer who is passionate about their work, eager to learn and grow, and who is committed to delivering exceptional results. If you are a team player, with a positive attitude and a desire to make a difference, then we want to hear from you. Role Overview Description Company Overview Tatvacare is a cu...

Ways of working : Mandate 3 - Employees will come to the office everyday at their base location. About Swiggy Instamart: Swiggy Instamart, is building the convenience grocery segment in India. We offer more than 30000 + assortments / products to our customers within 10-15 mins. We are striving to augment our consumer promise of enabling unparalleled convenience by making grocery delivery instant and delightful. Instamart has been operating in 90+ cities across India and plan to expand to a few more soon. We have seen immense love from the customers till now and are excited to redefine how India shops. Position: Assistant Manager - Regulatory (Private Label Business) Function: Regulatory & Co...

Medical Writer (CER) Role & Responsibilities: Writing and reviewing of clinical and regulatory documents related to Drugs, medical devices or in-vitro medical device Writing and reviewing clinical/regulatory documents such as clinical trial protocols, Clinical evaluation Plans, Clinical evaluation reports, investigator brochures, informed consent forms, according to ICH or other guidelines. Responsible for preparation of documents that support the presentation and/or publication needs of assigned therapeutic areas and/or medical devices in the clients Strategic Medical Affairs Team for a wide range of audiences. Responsible for compliant writing of Clinical Evaluation Reports, clinical study...

As an Electronics Engineer, you will be responsible for developing standalone electronic systems from concept to production. Your expertise in digital and analog circuit design, component selection, PCB design, and system-level simulation will be crucial for this role. Experience with medical electronics, compliance standards (IEC 60601, ISO 13485), and EMI/EMC-compatible design practices is essential for success. Key Responsibilities: - Lead the end-to-end design and development of electronic systems for standalone and embedded medical devices. - Design and simulate digital, analog, and mixed-signal circuits using tools such as LTSpice, Multisim, or Proteus. - Perform signal integrity, powe...

Associate - Clinical Quality Assurance (CQA) Department: QA - MakroCare and DDi Job Roles and Responsibilities: Perform maintenance, review, and approval of company Standard Operating Procedures (SOPs) in compliance with ISO standards and applicable international and national regulations. Prepare and review Quality Management System (QMS) documents, CQA procedures, and assist in reviewing department SOPs as needed. Manage SOPs in mLMS, create users, review training records, and escalate non-compliance issues to the Head of CQA or relevant department heads. Maintain the CQA document repository and archive validation protocols and documents in line with regulatory requirements. Conduct interna...

Role Overview: Adiuvo Diagnostics is looking for a highly motivated Principal Engineer & Head of R&D (Hardware & Optics) to spearhead the development of advanced medical diagnostic devices. As the ideal candidate, you will lead a talented team in designing and implementing innovative solutions from conception to market launch. Key Responsibilities: - Lead end-to-end research and development efforts in hardware, optical systems, and device integration. - Design, prototype, and validate new hardware and optics solutions for imaging and diagnostic platforms. - Collaborate closely with software, clinical, and regulatory teams to translate product requirements into scalable technical designs. - F...

As a dynamic and execution-driven Senior Manager R&D at Elmentoz, your role will involve leading the coordination, planning, and techno-administrative execution of cutting-edge product development programs. You will serve as the operational anchor between top management and scientific teams, ensuring timely delivery of R&D milestones across various areas such as product development, technical trials, IP, and regulatory documentation. Your strong project management skills, deep industry understanding, and excellent communication capabilities will be crucial in driving innovation with speed and precision. Your key responsibilities will include: - Leading the end-to-end execution of R&D program...

As a Purchase Executive for Raw Materials (Pharma API) in the Pharmaceutical / API industry, you will play a crucial role in managing the procurement activities of raw materials, specifically Active Pharmaceutical Ingredients (API). Your focus will be on sourcing and procuring raw materials from both domestic and international suppliers, ensuring cost efficiency, quality compliance, and timely availability. Key Responsibilities: - Source and procure raw materials (API) from domestic and international suppliers. - Manage the end-to-end procurement process, including supplier identification, price negotiation, purchase order creation, and order tracking. - Coordinate imports of small-quantity ...

SR. Executive/Assistant Manager/Manager - Regulatory Affairs Roles and Responsibilities - To prepare dossiers as per CTD/ACTD guidelines for product registration, renewal & variation applications to submit in regulated / semi regulated countries. - To arrange administrative documents required for dossier submission & export purpose (Manufacturing Lic, WHO-GMP, P.P/COPPs/FSC- Procuring and legalization). - To check & approve the artworks for regulated / semi regulated countries. - To Co-ordinate and follow-up with manufacturer for documents & samples/WS required for regulatory submission. -Handling queries pertaining to regulatory submissions from various regulatory authorities. - Maintain re...

As a Pharmaceutical Purchase Executive with 3+ years of experience in procurement, vendor coordination, and inventory management, your role will involve managing the end-to-end procurement process for pharmaceutical products. You will be responsible for identifying, evaluating, and negotiating with suppliers and manufacturers. Issuing purchase orders (POs) and tracking deliveries to ensure timely supply will also be a key responsibility. Additionally, you will maintain accurate records of purchase transactions, vendor terms, and pricing. Monitoring stock levels and coordinating with the sales and inventory team for replenishments is crucial. Ensuring compliance with pharmaceutical regulation...

Role Overview: As a member of Shree Clinical Services Pvt Ltd, you will be part of a clinical research organization that specializes in managing and conducting clinical trials across various therapeutic areas like oncology, cardiovascular diseases, and vaccines. The company places a strong emphasis on ensuring compliance with Good Clinical Practice (GCP) guidelines. Your role will involve providing end-to-end clinical trial management, which includes tasks such as patient recruitment, regulatory documentation, and data analysis. Key Responsibilities: - Manage and conduct clinical trials in oncology, cardiovascular diseases, vaccines, and other therapeutic areas - Ensure compliance with Good ...

As a Quality Engineering Specialist within the Medline UNITE Foot and Ankle Orthopaedics Division in Pune, India, you will play a crucial role in maintaining quality standards aligned with strategic engineering objectives. Your responsibilities include providing quality support for complaint investigations, routine product evaluations, product testing, documentation, and vendor qualification processes. Additionally, you will contribute to new product development and legacy engineering projects related to implantable foot and ankle products and accessories. Your ability to thrive in a team environment, demonstrate a strong sense of urgency, and build effective working relationships with peers...

Role Overview: As a Sales Support Lead, you will provide leadership to a sales support function to effectively collaborate with client partners, delivery leaders, and other functions. Your role involves optimizing sales support processes, tools, and procedures to ensure smooth team operations and effective collaboration. Key Responsibilities: - Serve as the main point of liaison for Delivery Leaders and Client Partners for sales support services - Prioritize and manage opportunities/proposal requests, work intake planning, and execution to meet demand - Suggest and implement new processes, tools, and procedures to enhance team functioning - Determine resource needs according to sales demand ...

Conduct NPD, process optimization, scale-up & value engineering. Develop synthetic routes, validate methods, identify raw material alternatives. Maintain documentation. Support validation & transfers. Coordinate with QA, QC & production.

Associate - Clinical Quality Assurance (CQA) Department: QA - MakroCare and DDi Job Roles and Responsibilities: Perform maintenance, review, and approval of company Standard Operating Procedures (SOPs) in compliance with ISO standards and applicable international and national regulations. Prepare and review Quality Management System (QMS) documents, CQA procedures, and assist in reviewing department SOPs as needed. Manage SOPs in mLMS, create users, review training records, and escalate non-compliance issues to the Head of CQA or relevant department heads. Maintain the CQA document repository and archive validation protocols and documents in line with regulatory requirements. Conduct interna...

Candidate must have thorough knowledge of Pharmacopeial, regulatory, FSSAI standards, ISO standards. Should be able to prepare and check technical documents such as Master manufacturing formula, Drug formula card, raw material specification, registration documents, Finished product specification. Should be able to check and finalize production documents such as Batch manufacturing record, Validation protocol, review scale up report and revise the document according. To prepare and check license application, artworks. Label claim etc. Material planning which includes store management, Purchase requisition &GRN preparation, bill clearance. Support to maintain calibration records. Any other act...

Execution and planning of compression / Coating / Capsule activity Troubleshooting of compression manchine / Coating machine / Capsule filling Recording of BMR, daily document, cleaning record, issuance of issuance of change part Exposure of audits (EU - GMP/ WHO / ROW / USFDA) Maintain the cleaniliness of area. Aware about the concept of GMP/GDP/Data integrity. Handling manpower

preparation and submission of registration dossier, renewal application and variation application for ANDA / ROW submission Preparation of respective CTD sections and submission of final query response to agency Preparation and submission of documents for national phase to respective European regulatory agency to receive national approval To upload documents in national portal for respective European regulatory agency Co-ordination with different department for getting required data for compilation of registration dossier, renewal application and variation Review of the mockups for all regulatory submissions and commercial supplies Maintenance of internal database Co-ordination with consulta...

As an MD in Microbiology, your role will involve preparing SOPs, protocols, and documentation for ongoing studies. You will be responsible for coordinating with other departments to meet clinical and laboratory requirements. Your key responsibilities will include ensuring ethical compliance and regulatory documentation as per standards. Qualifications Required: - MD in Microbiology - Prior experience in preparing SOPs and protocols - Strong understanding of ethical compliance and regulatory standards Please note that this is a contractual/temporary position and the work location is in person.,

As a Pathology MD working on a contractual/temporary basis, your role will involve preparing SOPs, protocols, and documentation for ongoing studies. You will be responsible for coordinating with other departments to meet clinical and laboratory requirements. Additionally, you will play a key role in ensuring ethical compliance and regulatory documentation in accordance with standards. **Key Responsibilities:** - Prepare SOPs, protocols, and documentation for ongoing studies - Coordinate with other departments for clinical and laboratory requirements - Ensure ethical compliance and regulatory documentation as per standards **Qualifications Required:** - MD in Pathology - Relevant experience i...

As a Regulatory Affairs Manager at Ferring India Laboratories, you will be responsible for the following key responsibilities: - Prepare, compile, and submit regulatory dossiers and submission data. - Manage Test and Manufacturing License applications with state and central drug authorities. - Handle regulatory submissions, variation filings, technical report writing, and query responses. - Ensure compliance with Drugs & Cosmetics Act, New Drug & Clinical Trial (CT) Rules, and GMP guidelines. - Ensure adherence to national and international regulatory requirements. - Review product labeling and artworks for regulatory compliance. - Liaise with state and central regulatory bodies (e.g., CDSCO...

As a Research Coordinator at Jothydev's Diabetes Research Centre, your role will involve assisting in trial management and site coordination, maintaining Trial Master Files (TMF) with proper documentation, and ensuring regulatory compliance. You will also be responsible for drug storage, dispensing, and accountability, as well as supporting patient enrollment and clinical trial material logistics. Additionally, you will schedule meetings, prepare agendas and minutes, demonstrating your technical and soft skills including knowledge of ICH-GCP guidelines, proficiency in Microsoft Office and clinical trial software, and strong organizational and communication abilities. Qualifications required ...

Role Overview: You will be responsible for planning and managing medical writing for Regulatory and Pharmacovigilance Verticals in compliance with applicable regulatory guidelines. Your main duties will include providing high-quality medical and scientific writing, offering technical consultation, demonstrating subject matter expertise, managing medical writing projects, collaborating with internal and external clients, and ensuring document output compliance with client specifications. Key Responsibilities: - Provide high-quality medical and scientific writing from planning and coordination of literature search through delivery of final drafts to internal and external clients. - Offer techn...

Role Overview: You will be responsible for preparing consistent and high-quality technical documents related to Pharmaceutical Research and Development for Formulation at Teva. Your role will involve executing all functions in accordance with current FDA regulations, ICH guidelines, USP methodologies, cGMPs, and SOPs. Maintaining open communication with R&D members to ensure timely delivery of high-quality documents independently with minimal supervision will be a key aspect of your responsibilities. Key Responsibilities: - Prepare documents and facilitate documentation management in R&D while ensuring correctness, completeness, and clarity following established guidelines. - Prepare documen...