114 Regulatory Documentation Jobs

Company Description Adiuvo Diagnostics is a techno-social enterprise focused on developing state-of-the-art platform technologies in optoelectronics. Our mission is to aid early disease detection and to enable advanced healthcare diagnostics in low-resource settings. We strive to bring cutting-edge diagnostic technologies to the places they are needed most. Job Description We are seeking a highly driven Principal Engineer & Head of R&D (Hardware & Optics) to lead the development of next-generation medical diagnostic devices. This role requires a unique blend of hands-on technical expertise, cross-disciplinary knowledge, and leadership skills. The ideal candidate will not only design and exec...

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...

You are a dedicated Quality Assurance Officer joining a team in Halol. Your experience in the chemical or pharmaceutical industry will be crucial as you ensure compliance with quality standards, implement QA protocols, and maintain regulatory documentation. Your role will involve overseeing quality assurance processes in production to uphold high standards, ensuring compliance with industry regulations and company policies, and updating quality documentation, reports, and audits. Collaborating with cross-functional teams to enhance quality standards will be essential, along with assisting in audits and regulatory inspections. You will be responsible for documenting and reporting product or s...

You will be joining our SCM II - Technical Publication team as a skilled Technical Writer. Your role will involve working on regulatory documentation with a focus on federal aviation/authority guidelines. It is essential for you to have experience in creating technical content that is clear, concise, and compliant with product, process, and UCS guidelines. Your responsibilities will include managing Configuration Management Processing tasks such as verifying and validating code changes for each version release, ensuring department practices align with procedures, analyzing software documentation for compliance, and addressing inquiries regarding software shipments and distribution requiremen...

We are looking for a highly experienced Senior Biostatistician Consultant with over 8 years of experience in statistical modeling, platform development, and advanced analytical solutions. This role requires in-depth knowledge of biostatistics, statistical process control, and extensive experience in developing and deploying R Shiny-based analytical platforms. As a Senior Biostatistician Consultant, you will play a crucial role in building scalable statistical platforms that facilitate data-driven decision-making through advanced analytics. Your responsibilities will involve guiding scientific data interpretation, supporting both regulated and non-regulated environments, and delivering top-no...

The Candidate will be responsible to the Business Operations for Global as well as Developing New Business Opportunity by focusing on building and growing strong relationship both internally and externally. Devising effective Business Development Strategy for future research-based products with global Clients in Nutraceutical, Dietary & Natural/ Herbal Supplements for all categories. KEY DELIVERABLES: Strategic and Operational Excellence Identifying opportunities to build, develop and strengthen relationships with global clients to grow and sustain the business by strategizing optimum customer selection and management, team expansion and nurturing a healthy cross functional team culture. Ide...

The Regulatory Affairs Executive is responsible for ensuring compliance with regulatory requirements for pharmaceutical products. Your primary role will involve preparing and submitting regulatory documentation, coordinating with internal teams, and staying informed about industry regulations. You will play a crucial part in ensuring product approvals and renewals, liaising with regulatory authorities, and reviewing product labeling to maintain regulatory compliance. Additionally, you will collaborate with cross-functional teams for data collection, maintain regulatory files, monitor regulatory guideline changes, and assist in audits and inspections by regulatory agencies. To qualify for thi...

Greetings! & very warm welcome to BEST-FIT Recruitment Riders, We are BEST-FIT Recruitment Riders feel immense pleasure to search and provide you with better carrier opportunities to aid you in achieving your aspirations. BEST-FIT Recruitment Rider is a highly specialized Recruitment & Executive Search Partner for Pharmaceutical, Biotech, CRO, Chemicals, Medical Devices & Turnkey Pharma Projects Engineering-Construction Design Sectors. We are searching & recruiting highly qualified professionals for Middle-Senior-Upper-Management and Executive jobs. (Eg: Managers, VP, President, CFO & CEO). Also offering customized recruitment services by Headhunting & Executive Search for Middle & Top manag...

The Biologics - II department at Zydus Biologics, located in Biotech Park, Changodar, Ahmedabad, is seeking a dynamic and experienced individual to join as an Executive / Senior Executive. As a key member of the Production team, you will be responsible for handling various aspects of USP Production and DSP Production. For USP Production, the ideal candidate should have experience in managing large-scale mammalian cell culture in SS bioreactor, media/feed preparation, and filtration processes. The role entails ensuring the readiness of bioreactor and associated vessels (CIP, FIT, PHT, SIP), operating bioreactor & associated vessels, preparing and operating centrifuge, and clarifying cells for...

As an Assistant Manager - Quality Assurance at Genuine Biosystem Pvt Ltd (GBPL) in Chennai, you will play a crucial role in ensuring that our In Vitro Diagnostic (IVD) products meet regulatory requirements and quality standards. With 13 years of market presence, GBPL is a leader in the Indian market for IVD reagents, kits, and Laboratory Medical equipment. Your responsibilities will include overseeing quality assurance processes, conducting quality audits, monitoring production processes, handling non-conformities, and collaborating with cross-functional teams to implement improvements swiftly. You will be expected to have experience in Quality Assurance, Quality Control, and Auditing within...

As a clinical research organization, Shree Clinical Services Pvt Ltd specializes in managing and conducting clinical trials across various therapeutic areas including oncology, cardiovascular diseases, and vaccines. The company is dedicated to ensuring compliance with Good Clinical Practice (GCP) guidelines to maintain high standards in the industry. Shree Clinical Services Pvt Ltd offers end-to-end clinical trial management services which include patient recruitment, regulatory documentation, and thorough data analysis. By leveraging their expertise and experience, the company aims to contribute significantly to the advancement of medical research and healthcare.,

You are looking for a Pharmaceutical Purchase Executive with over 3 years of experience in procurement, vendor coordination, and inventory management. Your responsibilities will include managing the end-to-end procurement process for pharmaceutical products, negotiating with suppliers, issuing purchase orders, maintaining purchase records, monitoring stock levels, ensuring compliance with regulations, and developing relationships with vendors. Additionally, you will work closely with the QA/Regulatory team, provide regular reports on purchase costs, lead times, and vendor performance. You should have a minimum of 3 years of experience in a similar role within the pharmaceutical industry, a s...

As a Drug Regulatory Affairs Specialist at MEDYUR PHARMACEUTICALS LIMITED, you will be responsible for ensuring compliance with regulatory requirements for our products. Your role will involve collaborating with cross-functional teams to drive successful product launches and maintain regulatory compliance. Your responsibilities will include preparing and submitting regulatory documentation, staying updated on global regulatory requirements, developing relationships with regulatory bodies, reviewing changes in regulatory policies, conducting regulatory impact assessments, maintaining regulatory files, and supporting regulatory inspections and audits. You will also collaborate with internal te...

You are invited to join Global Calcium Pvt. Ltd., a prominent API manufacturing company located in Bangalore, India, specializing in speciality API's, benzodiazepines, ophthalmics, oncology, chelated minerals, and organic mineral salts. We are currently seeking talented individuals to fill various roles in the QC Department. Open Positions: - QC ICP-MS Analyst (2 openings) - QC DMF Support (2 openings) - QC Analytical Validation Support (2 openings) - QC Wet Analysis (2 openings) Qualifications: - B.Sc./M.Sc. in Chemistry or related fields - 1 to 4 years of relevant pharmaceutical QC experience - Familiarity with cGMP practices and regulatory compliance Responsibilities: - Perform routine an...

You will be joining our Clinical Operations team in India, Mumbai as a full-time office-based Experienced Study Start-up Submissions Coordinator. Your role will be crucial in accomplishing tasks and projects that are essential for the success of our company. If you are seeking a rewarding career where you can utilize your expertise and further develop and grow professionally, this opportunity is perfect for you. At Medpace, we foster a culture of expertise and empowerment, allowing our teams to leverage their unique talents and experiences to approach research and problem-solving assertively, thereby supporting our business partners effectively. Our employees embody our values and commitment...

Position Title LRC Specialist - IMEA Function/Group Innovation, Technology & Quality (ITQ) Location Mumbai Shift Timing 09:00am - 06:00 pm Role Reports to Sr. FSQ Manager - LRC ASIA Remote/Hybrid/in-Office Hybrid ABOUT GENERAL MILLS We make foodthe world loves: 100 brands. In 100 countries. Across six continents. With iconic brands like Cheerios, Pillsbury, Betty Crocker, Nature Valley, and Hagen-Dazs, we've been serving up food the world loves for 155 years (and counting). Each of our brands has a unique story to tell. How we make our food is as important as the food we make. Our values are baked into our legacy and continue to accelerate us into the future as an innovative force for good. ...

We are seeking an experienced and proactive Treasury Manager Forex to lead our treasury operations, FX dealing, remittance settlements, and interbank transactions. The ideal candidate should have a strong background in forex trading (retail and wholesale), derivatives hedging, SWIFT-based settlements, and regulatory documentation. This is a critical role ensuring optimal fund utilization, accurate compliance, and efficient treasury processes Manage day-to-day FX treasury desk operations (retail & wholesale forex). Quote rates for branches and clients, and hedge open positions through interbank transactions). Circulate daily card rates and manage FX liquidity across locations. Supervise treas...

You will be responsible for managing all aspects of Bill of Entry processing and associated documentation for import/export operations. Your main duties will include preparing, filing, and overseeing the Bill of Entry process for imported goods, ensuring accuracy and timely submission of documents to meet regulatory requirements, maintaining and updating shipping and import/export documents, ensuring compliance with customs regulations, and coordinating with external agencies for smooth operations. To qualify for this role, you should have 4-8 years of experience in import/export documentation and customs clearance. You should possess in-depth knowledge of Bill of Entry, Shipping Bills, and ...

UMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations including Injectables, Tablets, Capsules, Suspensions, Dry Syrups, etc. Our manufacturing facility, situated in Vapi (Gujarat), holds approval from global regulatory authorities. Founded in 1983, UMEDICA operates in over 85 countries across the globe, encompassing EU, UK, USA, Canada, Australia, Middle East, Central & South American countries, Africa, Asia & CIS countries. Upholding a culture of innovation & continuous improvement, we at UMEDICA constantly strive for excellence. We are currently looking for a dynamic and experienced Manager/ Sr. Manager specializing in ...

We are seeking a Regulatory Affairs Executive with 1 to 3 years of experience in the pharmaceutical industry. The ideal candidate should have hands-on experience in compiling and reviewing ACTD and CTD dossiers for various regulatory submissions. Responsibilities include preparing, compiling, and maintaining regulatory documentation in accordance with regional requirements, coordinating with cross-functional teams to gather necessary data, and ensuring timely submission of dossiers. The candidate should be well-versed with regulatory guidelines, and capable of handling multiple projects simultaneously.

Job Summary: We are looking for a highly skilled and experienced Clinical Research Scientist with a strong background in Bioequivalence and Bioavailability (BE/BA) studies and clinical operations . The ideal candidate will have over 10 years of experience in the pharmaceutical industry, with a minimum of 7 years in BE/BA studies, and a deep understanding of regulatory requirements for highly regulated markets including USFDA, EMA (EU), and Health Canada . This role also involves overseeing clinical trials as a Sponsors Representative , managing end-to-end clinical processes, ensuring regulatory compliance, and coordinating with various stakeholders for successful study execution and document...

DEPARTMENT: Corporate Solutions As a member of the COSEC Team you will be expected to work in collaboration with other members of the Team, assist and support in providing administrative, compliance and regulatory services of to overseas client Companies, in accordance with applicable policies and procedures, regulatory requirements, service levels and company standards so as to satisfactorily meet client expectations. The Role: Understanding corporate and legal compliances as per jurisdiction in which client companies are located. Handling compliances and documentation under the applicable anti-money laundering regulations. Handling compliance relating to Board Meetings of overseas client c...

DEPARTMENT: Corporate Solutions As a member of the COSEC Team you will be expected to work in collaboration with other members of the Team, assist and support in providing administrative, compliance and regulatory services of to overseas client Companies, in accordance with applicable policies and procedures, regulatory requirements, service levels and company standards so as to satisfactorily meet client expectations. The Role: Understanding corporate and legal compliances as per jurisdiction in which client companies are located. Handling compliances and documentation under the applicable anti-money laundering regulations. Handling compliance relating to Board Meetings of overseas client c...

About The Role : We are seeking a detail-oriented and experienced Biostatistician II to support statistical analyses for clinical research studies. This role involves developing and validating SAS programs, preparing statistical documentation, and ensuring compliance with regulatory standards such as CDISC. The ideal candidate will have a strong foundation in statistics, clinical trial methodology, and statistical programming. Key Responsibilities: Develop, validate, and maintain SAS programs to generate analysis datasets, tables, listings, and figures (TLFs) as per statistical analysis plans. Design and verify randomization codes to ensure clinical trial integrity. Prepare statistical secti...

#hiring for a Leadership role in #RegulatoryAffairs with reputed organization into Hi-end Medical Devices industry. Job Title: Director /VP (Regulatory Affairs) Location: Gurgaon Reports To: CEO About the Role We are seeking a highly skilled Regulatory Affairs Specialist to support global regulatory activities for our advanced Medical Devices/Equipments . This role plays a key part in developing regulatory strategies, managing submissions, and ensuring ongoing compliance for Class II and III medical devices. The successful candidate will have experience working with global health authorities, especially the US FDA , and a deep understanding of the regulatory landscape for complex medical tec...