119 Ich Guidelines Jobs - Page 2

Role Overview: You should have a good knowledge of ANDA submission activities and post-approval procedures along with related ICH and USFDA guidelines. Your responsibilities will include API DMF review in accordance with USFDA regulatory requirements, exposure to various dosage forms, preliminary review of change cases, drafting annual reports, reviewing submission packages, drafting controlled correspondence, and ensuring regulatory submissions are completed without delay. Coordination with cross-functional teams and maintaining regulatory information will also be part of your role. Key Responsibilities: - Review API DMF with respect to USFDA regulatory requirements - Understand and brief m...

As a Technical Document Specialist, your role will involve preparing various technical documents such as COA, MSDS, Specifications, Method of Analysis, Stability Data, DMF, and Declarations. You will also be responsible for the preparation of vendor questionnaires and responding to customer queries. It is essential to have a solid understanding of Pharmacopoeias and ICH guidelines. Your proficiency in MS Office, Outlook, Microsoft Word, and a good typing speed will play a crucial role in your success in this position. Your key responsibilities will include: - Preparation of Technical documents including COA, MSDS, Specifications, TDS, Method of Analysis, Stability Data, DMF, and Declarations...

As an Associate Medical Reviewer at Novo Nordisk Global Business Solutions (GBS) India, located in the Centralised Monitoring Unit (CMU) department in Bangalore, Karnataka, IN, you will have the opportunity to work in a challenging and dynamic environment. Your primary role will involve conducting comprehensive medical reviews of clinical trial data across various therapy areas within the drug development portfolio. Your key responsibilities will include: - Ensuring the highest quality and consistency of medical data - Emphasizing patient safety, protocol adherence, and compliance with GCP, ICH guidelines, local regulations, and SOPs - Collaborating closely with study team members such as Da...

Job Description: You should have exposure to Method Development, Method Validation, and Method Transfer as per the requirement of ICH. You will be responsible for preparing protocols and executing planning for activities as per the product requirement. Key Responsibilities: - Develop methods for analysis - Validate methods according to ICH guidelines - Transfer methods to different locations as necessary Qualifications Required: - Experience in Method Development, Validation, and Transfer - Knowledge of ICH guidelines,

Role Overview: As a Regulatory Affairs Specialist, you will be primarily responsible for the compilation, preparation, and review of Drug Master Files (DMFs) for various markets such as US, Europe, Canada, and ROW in specified eCTD, NeeS, or CTD formats. Your role will also involve setting specifications for API process development and having knowledge of litigation related to Drugs and Cosmetics Act. Ensuring compliance with audits from regulatory bodies like USFDA and EU, as well as generating documents from departments like R&D, Production, QC, and QA for newly developed API's will be crucial. Key Responsibilities: - Compiling, preparing, and reviewing DMFs for different regions - Filing ...

You will be joining the Formulation R&D team at Hetero Drugs as a Scientist II, focusing on the development of sterile injectable formulations, including aqueous, non-aqueous, lyophilized, and peptide-based oncology products. Your role will be crucial in advancing product development for regulated markets such as the US, Europe, and ROW. You will be responsible for comprehensive formulation design, process optimization, regulatory documentation, and coordination across departments. - Independently lead the development of sterile injectable products, including aqueous, non-aqueous, lyophilized, and peptide-based formulations. - Conduct formulation studies, process optimization, and scale-up a...

As a TMF Reviewer at Fortrea, your role involves performing TMF review of electronic Trial Master Files (eTMF), Trial, Country, and Site artifacts for clinical studies in support of sponsors services contracts and internal Fortrea business needs. Key Responsibilities: - Provide process, control, coordination, and approval of clinical trial documents. - Manage ECD, Phase I-IV electronic trial master file (eTMF). - Maintain an understanding of applicable regulatory requirements. - Manage electronic Trial Master Files (eTMF), (Trial, Country, and Site artifacts) for clinical studies in accordance with TMF processes, collaborating with key study personnel such as the Study Team Member. - Perform...

As a Team Lead in Global Regulatory Affairs - API team at Dr. Reddys Laboratories Ltd., you play a crucial role in guiding and supporting your team in their operations. Your responsibilities include: - Defining regulatory requirements for the selection of Drug Master File starting materials and their suppliers - Guiding the teams in setting specifications for the starting materials, intermediates & Active Pharmaceutical Ingredient - Providing inputs for defining the control strategy for PGIs, nitrosamines & other regulatory expertise required - Ensuring smooth execution of regulatory filings globally according to the established plan - Monitoring and assessing the progress of Drug Master Fil...

About the client: PSS has been mandated to hire a Regulatory Affairs Manager for one of the leading pharmaceutical companies in India. Job Purpose To register Formulation products in the European markets, handling all submissions and taking care of all queries. Key Responsibilities The candidate should have sound knowledge of all Regulatory Filings, be well-versed in e-CTD, Dossier submissions, be familiar with ICH guidelines, handled Educe dossier management and Lorange Doc bridge software for eCTD compilation and publishing. Preparation of quality dossier (eCTD, CTD, ACTD, and Checklist) with regulatory compliance with respect to country requirements. Preparation of e-CTD dossier submissio...

As the Data Management Manager at our company, your role involves overseeing the daily operations and strategic development of the clinical data management team. You will be responsible for ensuring the accuracy, integrity, and compliance of clinical trial data while providing leadership, training, and performance oversight to data specialists. The ideal candidate for this position is hands-on, with proven experience in clinical data entry, query resolution, coordinating complex interventional clinical trials, leadership skills, and a collaborative mindset. **Key Responsibilities:** - **Team Leadership & Oversight:** - Supervise, mentor, and support a team of Clinical Data Specialists, ensur...

Role Overview: As an Associate Manager / Manager in API Regulatory Affairs - DMF Filing/ Compilation for the global market, your responsibilities will include: - Hands-on experience in Regulatory Affairs-API/DMF Filing/DMF Compilation/ Submission/ Customer Communication. - Compiling and submitting DMFs globally for small molecule APIs in eCTD format, ensuring compliance with ICH and region-specific regulatory guidelines (EU, US, Canada, Japan, Australia, Brazil, China, South Korea, etc.). - Demonstrating good knowledge of all regulatory guidelines and API Regulatory processes. - Compiling responses to queries from Regulatory Agencies & customers globally, meeting specified timelines for subm...

Job Description: You will be responsible for delivering lectures, practical classes, and tutorials in Pharmaceutical Chemistry / Cognosy to undergraduate and postgraduate students. Additionally, you will design and implement curriculum updates in line with current industry trends and regulatory standards. Supervising student projects, dissertations, and lab research work will be a key responsibility. You are expected to guide students in the use of analytical tools and drug design software. Furthermore, initiating and publishing research in recognized national and international journals is an essential aspect of the role. Ensuring adherence to PCI, AICTE, and NAAC documentation and academic ...

Role Overview: As an experienced Regulatory Affairs Specialist with a strong educational background in M. Pharmacy, you will be responsible for various key activities related to regulatory affairs in the pharmaceutical industry. Your expertise in regulatory activities such as CTD dossier preparation, query solving, and thorough knowledge of ICH guidelines will be crucial for the successful submission of dossiers to regulatory authorities. Key Responsibilities: - Prepare and submit new dossiers in compliance with regulatory requirements - Conduct gap analysis of dossiers to ensure completeness - Compile dossiers in eCTD format for submission to regulatory authorities - Coordinate the submissi...

Job Overview Responsible to provide support lab compliance activities. Summary Of Responsibilities These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills, and duties as individual contributor globally. Review and approval of documents such as but not limited to protocols and report for Method qualification, method validation, transfer; methods; investigations. Handling of Quality Issues, Corrective/Preventive Actions, and Change Controls related to the client as well as their contract laboratories Works with the supported departments to maintain and continuously improve the quality culture to posit...

As a Regulatory Medical Writer-Clinical trials (RMW-CT), you are responsible for providing regulatory affairs (RA) strategic document expertise and support to one or more therapeutic areas (TAs) as designated by leadership. You will provide support for the preparation and submission of critical RA documents and responses to health authority (HA) or sponsor information requests using available reference materials such as documentation of previous interactions with HAs and sponsors, clinical development documentation, scientific literature, and content provided by sponsor teams. You may be the lead contact for sponsor or designated HAs interactions with cross-functional teams contributing to t...

Process Development & Optimization Lead scale-up and tech transfer of formulations from R&D to commercial manufacturing. Optimize existing manufacturing processes for efficiency, cost-effectiveness, and quality. Technology Transfer 1. Coordinate cross-functional teams to ensure smooth transfer of products between sites or from development to production. 2. Prepare and review technology transfer documentation (TTDs, protocols, reports). Troubleshooting & Support 1. Provide technical support to manufacturing units for resolving process deviations, equipment issues, and quality concerns. 2. Investigate root causes and implement corrective/preventive actions (CAPA). Documentation & Compliance 1....

Job Title: Executive / Sr. Executive - Quality Management System (Analytical Assurance) Department: Quality Management System Reports to: Manager Location: Ankleshwar Position Type: Full-time Qualifications And Experience Education: B.Pharm / M.Pharm / M.Sc in Chemistry, Biotechnology, or related field. Experience: Minimum 68 years of experience in Analytical Assurance within the pharmaceutical industry Job Responsibilities & Accountabilities We are looking for an experienced Analytical Assurance professional to join our team and lead the Out of specification investigation, along with core QMS activities pertaining to QC. Key Responsibilities Trigger out of specification investigations upon ...

As a Clinical Data Scientist at Novartis in Hyderabad, your role involves using advanced data management tools and techniques to ensure professional and lean execution of Data Management products and milestones for all assigned trials within Clinical Data Acquisition and Management. Your primary responsibility is to ensure consistently high-quality data is available for analysis and reporting. Key Responsibilities: - Provide data management input on Clinical Trial teams and may act as a Trial Data Scientist on small low complexity trials - Perform data management activities for the startup of a study, including preparing the eCRF, CCGs, Data Quality plan (DQP), Data Quality Plan Module (DQPM...

The Site Care Partner is a key Pfizer point of contact for investigative sites throughout a study life cycle; accountable for site start-up activities through site activation; accountable for building and retaining investigator site relationships and providing support from site recommendation through the lifecycle of studies; accountable for site-level recruitment and accountable for safeguarding the quality and patient safety at the investigator site. The Site Care Partner contributes to country and site selection activities by proactively collaborating with key stakeholders and providing local intelligence to country outreach surveys, investigator strategies and Pfizer pipeline opportuniti...

About Us Friday Plansis a technology-driven US-based company evolving from a leading online pharmacy into a vertically integrated pharmaceutical company. Our mission is to develop, manufacture, and commercialize our own portfolio of medicines for the US market. We are seeking a seasoned regulatory leader to navigate this journey and build our regulatory function from the ground up. Position Summary We are looking for a strategic and hands-on Director of Regulatory Affairs to lead all regulatory activities for our product portfolio targeting the US market. This individual will be responsible for developing and executing the regulatory strategy for our pipeline, from early development through ...

In pursuit of future expansion, we need Formulation & Development Officer/ Sr. Officer - 2-4 years in advanced probiotic/ nutraceutical / food supplement /phyto-pharmaceutical formulation development in solid orals (Tablet/Capsule/Granules/Powder) /Liquid Orals (Syrup/Suspension/Liquids) / semi-solid (Cream/ointment/ gel/paste). The candidate should preferably possess one or more of below requisites: 1.Knowledge of steps involves in Formulation and development. 2.Experience in development of Nutraceutical/ advanced probiotic/herbal formulations 3.Knowledge of GMP, GLP, D&C Act, ICH guidelines, FSSAI & AYUSH. 4.Ability to take lab trail and other lab related activity. 5.Ability to prepare the...

Company Description AMN Life is a leading manufacturer and exporter of a wide range of formulations in various therapeutic segments including antibiotics, gastro, anti-inflammatories, cardiology, nephrology, CNS, and oncology. With facilities approved by EU, Health Canada, Brazil - Anvisa, and Philippines situated in Bhilad (Gujarat) and Kala Amb (Himachal Pradesh), AMN Life is equipped to handle large scale production and tech transfer projects. Headquartered in Bandra Kurla Complex, Mumbai, with offices in Singapore, UK, Australia, and Philippines, AMN Life excels in providing quality medicines at affordable prices globally. We are recognized for our strong global presence, innovative R&D,...

As a QA Chemist at Sinterx Pharma Private Limited, you will play a crucial role in ensuring that all API intermediate manufacturing operations adhere to established quality standards, GMP requirements, and regulatory guidelines. Your responsibilities will include: - Reviewing and approving GMP documentation such as BMRs, BPRs, SOPs - Overseeing batch records, managing deviations, and CAPA - Conducting internal audits and ensuring compliance throughout the production lifecycle Qualifications required for this role include: - Bachelor's or Master's Degree in Chemistry, Pharmaceutical Sciences, or Life Sciences - 5 to 8 years of experience in Quality Assurance within the API or API Intermediate...

As a Senior Technical Officer - Phytochemist, you will be instrumental in designing innovative products and ensuring the scientific standardization of Ayurvedic formulations. Your key responsibilities will include: - Leveraging your Phytochemical Expertise by demonstrating in-depth knowledge of the chemical composition of medicinal plants, active compounds, and secondary metabolites, and utilizing chromatographic and spectroscopic techniques for compound identification and quantification. You will also identify synergistic interactions among plant constituents to optimize therapeutic efficacy. - Driving Product Development by formulating Ayurvedic products tailored to address lifestyle disea...

As a Scientist at USP, your role will involve conducting necessary analytical tests on Verification samples (Dietary supplements/Dietary Ingredients) utilizing suitable methods to enhance the laboratory's scientific proficiency and work ethic. You will offer extensive technical support and knowledge and provide valuable observations and insights into challenging projects. Your responsibilities will include: - Conducting verification projects (Dietary Supplements/Dietary Ingredients) by performing individual analytical tests such as HPLC, GC, Dissolution, ICP-MS, ICP-OES, and wet analysis as assigned - Completing projects within designated timelines and priorities - Demonstrating a robust sci...