2 Dmf Submissions Jobs

Dear All, Greetings from Biophore !! This is an opportunity with Biophore in Regulatory affairs -API Department . Please go thorough the JD. Interested candidates share your CV's to "recruitments@biophore.com". Location : Pashamylaram, Patancheruvu . Job description : Roles and Responsibilities DMF submissions, Annual Reports, Variations, Renewals etc. for US and Europe market. Compilation and publishing in eCTD/CTD format for Submission to health agencies like EDQM, USFDA etc. Oversee final technical quality review and technical validation (PDF/eCTD/NeeS) Review all regulatory agency submission materials for accuracy, comprehensiveness, or compliance with regulatory standards. Provide deficiencies responses to HA regulatory agencies for deficiencies and comments Evaluation of change controls for post-approval changes (PAC) Compilation, review and submission of Variations Keeping up to date with changes in regulatory legislation and guidelines Conduct Pre-submission and Initial Submissions meetings Preparation of gap analysis report of CMC regulatory submission including recommendations to facilitate the review of application by HA Gaps in manufacturing and controls, assessment of regulatory risk and strategy Providing gap analysis against applicable HA requirements and standards and communicate cross functional team to comply the samezCharacterization of the API and Raw materials used to manufacture the API Description of the product and process development Analytical methods and specifications used for testing Release and stability testing data for both the API Preparation of responses to HA,comment letters&assessment reports Initial assessment of the submission (initial / post approval submissions) E.g., initial validation comments, response to the completeness assessment report, response to the Information Requests

We are looking for a meticulous Assistant Manager R&D to spearhead API development initiatives at Glochem Industries. As Assistant Manager, you will play a crucial role in executing complex organic syntheses, optimizing reaction conditions, and assisting in the development of scalable and environmentally friendly synthetic routes for API manufacturing. Your responsibilities will span from meticulous documentation of experimental procedures and results to collaborating with cross-functional teams, including analytical, kilo lab, and pilot plant teams, for sample analysis and process scale-up. The ideal candidate will have a strong foundation in organic chemistry, a deep understanding of API manufacturing processes, and familiarity with pharmaceutical industry regulations. You will also contribute to technology transfer activities, troubleshoot synthetic issues, and ensure compliance with safety protocols. This role demands a proactive approach to staying updated on recent literature, participating in team discussions, and supporting the preparation of technical reports and regulatory documentation. Your expertise will directly influence the efficiency and quality of our API development pipeline, ensuring Glochem Industries maintains its position as a leader in the pharmaceutical industry. Job Details: Industry: Pharmaceuticals Department: Research & Development Role: Assistant Manager R&D Location: Hyderabad Compensation: 6-10 LPA Experience: 5-10 years Employment Type: Full-time Qualification: Master’s or PhD in Organic Chemistry or related field Responsibilities: Organic Synthesis and API Development Execute multi-step organic syntheses for API development, adhering to established protocols and under the guidance of senior scientists. Optimize reaction conditions to enhance yield, purity, and cost-effectiveness of API synthesis. Develop scalable and environmentally friendly synthetic routes for API manufacturing, considering green chemistry principles and Glochem Industries' sustainability goals. Troubleshoot synthetic issues during development, employing analytical techniques and literature review to identify and resolve problems. Ensure compliance with chemical safety procedures and handle hazardous chemicals responsibly, following GLP guidelines. Assist in the preparation of development summaries and technical reports, documenting key findings and experimental data for API projects. Research and Development Conduct literature searches and stay abreast of the latest advancements in organic chemistry and API development to identify innovative solutions. Design and execute experiments to investigate new synthetic methodologies and optimize existing processes for API production. Collaborate with cross-functional teams to identify and evaluate potential new API candidates for development. Contribute to the development of intellectual property, including patent applications, related to novel synthetic routes and API formulations. Analyze and interpret experimental data to draw conclusions and make recommendations for future research directions. Present research findings at internal meetings and contribute to the preparation of scientific publications and presentations. Project Management Assist in the planning and execution of API development projects, ensuring adherence to timelines and budgets. Track project progress and identify potential roadblocks, proactively proposing solutions to mitigate risks. Coordinate with internal and external stakeholders to ensure effective communication and collaboration throughout the project lifecycle. Contribute to the preparation of project reports and presentations, summarizing key findings and progress updates for management review. Participate in project team meetings and contribute to the development of project strategies and objectives. Manage laboratory resources and equipment to ensure efficient operation and support project activities. Compliance & Safety Ensure strict adherence to Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) guidelines in all aspects of API development. Maintain accurate and complete documentation of all experimental procedures, data, and results in accordance with regulatory requirements. Participate in internal audits and inspections to ensure compliance with company policies and regulatory standards. Implement and maintain a strong safety culture within the laboratory, promoting safe work practices and adherence to safety protocols. Conduct risk assessments for all experimental procedures and implement appropriate control measures to minimize hazards. Ensure proper handling, storage, and disposal of hazardous chemicals and waste materials in accordance with environmental regulations. General Expectations and Past Experiences: Master’s or PhD in Organic Chemistry with 5-10 years' API development experience in the pharmaceutical industry, focusing on organic synthesis and process chemistry. Independently execute and troubleshoot multi-step organic syntheses, optimizing reaction conditions for yield, purity, and scalability. Utilize NMR, HPLC, GC-MS, and LC-MS for sample analysis, characterization, and impurity profiling to support API development and process optimization. Maintain a strong understanding of FDA, ICH, and GMP guidelines to ensure regulatory compliance in R&D activities. Contribute to DMF submissions and other regulatory documents, ensuring accuracy and completeness. Participate in experiment design and execution for process development, optimization, and validation of APIs. Contribute to identifying and evaluating new technologies and synthetic methodologies to enhance API development capabilities.