9 Ich Guidelines Jobs

Review Site Visit Reports (SVRs) to ensure they meet or exceed quality standards and support goals of quality, subject safety, data integrity and regulatory compliance. Use tools and techniques to ensure the efficient and effective review of Site Visit Reports and their associated attachments, in compliance with IQVIA SOP, ICH/ GCP guidelines, and protocol requirements Essential Functions Oversee a caseload of SVRs for assigned studies, ensuring compliance to the protocol, processes, timelines, IQVIA/applicable SOPs, and GCP guidelines. Review SVRs to ensure findings requiring corrective and /or preventative action plans are documented and followed up to resolution, to ensure high quality reports. Participate on the project team for all SVR review activities and identifies and escalate CRA and /or site issues, relevant trends, and related risk factors to the project team and appropriate parties in a timely manner to optimize quality of project delivery. Provide guidance to Clinical Project Managers (CPMs) at project start-up and throughout the study and partner with the project team members to decrease the level of corrections/additions needed on reports by providing insight and training of the SVR annotations. Identify and track the project team compliance to SOPs for submission and approval of the SVRs through communication with the CRAs and line managers. Participate in meetings with project team to discuss any SVR review issues illustrative of quality/performance deficiencies across PIs/sites and CRAs. Assist with identification of the trends emerging from the Issue Escalation Log. Provide coaching to CRAs to decrease the level of corrections/additions needed on reports. Provide quality improvement support such as quality checks, data trending, providing back up support and mentoring and coaching of junior staff members. May take on special project assignments related to function/corporate initiatives. Qualifications Bachelors Degree Healthcare or other scientific discipline or educational equivalent Req 7-8 years of Clinical Research experience, including a minimum of 3 to 4 years on-site monitoring experience Req Or Equivalent combination of education, training and experience. Req Strong knowledge of and skill in applying, applicable clinical research regulatory requirements; i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Through knowledge and understanding of the Clinical monitoring processes and sound knowledge of clinical trial systems and applications Demonstrated skill in understanding and executing complex study designs as well as multiple studies Strong written and verbal communication skills. Effective time management and organizational skills, and the ability to manage competing priorities Ability to work independently with good analytical and problem solving skills Demonstrated ability to work across cultures and geographies with a high awareness and understanding of cultural differences High quality orientation, with a focus on attention to detail Ability to establish and maintain effective working relationships with coworkers, managers and clients. Fluent in English, both spoken and written.

We are seeking a meticulous and experienced Manager Quality Control to lead and enhance our quality control operations at Synnat Pharma Private Limited. In this pivotal role, you will be instrumental in overseeing all aspects of quality control, ensuring adherence to Good Laboratory Practices (GLP), and maintaining a robust Quality Management System (QMS). Your expertise will be crucial in driving Analytical Method Development, managing CAPA and Change Control processes, and upholding Data Integrity standards. You will lead a team of QC analysts, providing training and mentorship to foster a culture of excellence. The ideal candidate will possess a strong understanding of ICH Guidelines and Regulatory Compliance, with hands-on experience in GC and HPLC. This role demands a proactive approach to QC process improvement, meticulous QC documentation, and the ability to conduct thorough analytical data reviews. Job Details: Industry: Active Pharmaceutical Ingredient (API) Department: Quality Control Role: Manager - Quality Control Location: Visakhapatnam Compensation: 12 -15 LPA Experience Required: 10 - 15 years Employment Type: Full-time Required Qualification: Bachelor's degree in Chemistry, Pharmacy, or a related field Responsibilities: Analytical Method Development and Validation Lead the development, validation, and transfer of analytical methods for API testing in compliance with ICH and regulatory requirements. Review validation protocols and reports, ensuring accuracy and completeness. Troubleshoot analytical challenges and provide technical guidance. Collaborate with AR&D to optimize methods for both new and existing products. Ensure complete documentation of method development and validation activities. Quality Management System (QMS) and Compliance Maintain and improve the QMS to comply with regulatory standards (US FDA, EU GMP). Oversee CAPA and Change Control processes to address quality deviations. Conduct internal audits to ensure procedural compliance and identify improvement areas. Ensure adherence to Data Integrity principles across QC operations. Serve as the key QC contact during regulatory inspections and audits. Laboratory Operations and Equipment Management Supervise daily QC laboratory operations and ensure efficient sample testing. Oversee calibration and maintenance of laboratory instruments (GC, HPLC). Monitor lab environmental conditions and implement corrective actions where needed. Ensure sufficient availability of reagents, standards, and consumables. Implement lab safety procedures and optimize workflows to improve turnaround time. Team Leadership and Performance Management Lead and mentor QC analysts, fostering a collaborative and improvement-driven culture. Conduct performance evaluations and provide development-focused feedback. Design and deliver technical training programs to enhance team capability. Assign responsibilities to ensure a balanced workload and accountability. Address employee concerns and promote a positive, inclusive work environment. Data Analysis and Reporting Oversee review and interpretation of analytical data for compliance and reliability. Approve QC reports including Certificates of Analysis (CoAs). Identify trends and take proactive measures to address quality concerns. Present QC metrics and insights to management and cross-functional stakeholders. Maintain accurate records and use statistical tools to evaluate data. General Expectations and Past Experiences: Strong understanding of pharmaceutical QC principles and global regulatory standards (US FDA, EU GMP). Demonstrated expertise in analytical method development and validation with hands-on experience in GC and HPLC. Proven track record of maintaining QMS aligned with ICH guidelines. Experience managing CAPA, Change Control, and Deviation processes. Deep commitment to Data Integrity and documentation compliance. Strong leadership skills with a track record of mentoring high-performance teams. Excellent interpersonal, communication, and analytical problem-solving abilities.

We are seeking a meticulous and experienced Executive/Sr. Executive to spearhead chromatographic analysis and data review at Synnat Pharma Private Limited, a rapidly growing API manufacturer. In this pivotal role, you will be responsible for ensuring the accuracy, reliability, and compliance of analytical data generated within our QC laboratory. Your expertise will be crucial in adhering to stringent regulatory standards, including ICH guidelines and pharmacopeial requirements, while contributing to the overall quality and integrity of our pharmaceutical products. The ideal candidate will possess a strong understanding of HPLC and GC systems, coupled with proficiency in Empower CDS and a deep commitment to data integrity and GLP/GMP principles. This role demands a proactive individual capable of troubleshooting analytical issues, leading OOS/OOT investigations, and implementing effective CAPA measures. You will collaborate closely with cross-functional teams to maintain a robust Laboratory QMS and ensure seamless method of transfer and validation processes. If you are passionate about pharmaceutical sciences and dedicated to maintaining the highest standards of quality in API manufacturing, we encourage you to apply. Job Details: Industry: Active Pharmaceutical Ingredient (API) Manufacturing Department: Quality Control Role: Executive/Sr. Executive Location: Visakhapatnam Compensation: 4,00,000 to 8,00,000 INR per annum Experience: 4-7 years Qualification: Bachelor's or Master's degree Chemistry, or a related field Employment Type: Full-time Responsibilities: Chromatographic Analysis and Data Review Perform chromatographic analysis of raw materials, in-process samples, and finished products using HPLC and GC techniques, ensuring compliance with established test procedures and pharmacopeial requirements. Review chromatographic data generated by other analysts for accuracy, completeness, and compliance with data integrity and GDP. Troubleshoot HPLC and GC systems, resolving issues to ensure reliable instrument performance. Participate in method validation and transfer activities in line with regulatory expectations. Analyze stability samples and maintain data integrity in accordance with ICH guidelines. Prepare reports summarizing analytical results and findings. Quality Control and Compliance Implement and maintain a robust Laboratory QMS as per GLP, GMP, and internal quality standards. Lead OOS and OOT investigations and implement corrective actions to prevent recurrence. Manage and document CAPA activities effectively. Ensure data integrity through robust controls and secure data handling practices. Participate in audits and address regulatory observations. Maintain accurate documentation as per GDP guidelines. Laboratory Operations and Maintenance Oversee calibration and maintenance of HPLC and GC systems. Manage lab supplies and ensure proper storage and inventory control. Maintain a clean and compliant lab environment. Train junior staff in instrumentation, methods, and data practices. Develop SOPs and contribute to continuous improvement of test procedures. Support cross-functional teams in resolving quality-related issues. Stakeholder Management and Reporting Collaborate with R&D, production, and regulatory affairs teams. Communicate analytical findings effectively for decision-making. Prepare periodic reports for management summarizing QC trends. Participate in regulatory inspections and audits. Coordinate with external vendors for analytical services. Represent the QC department in internal/external meetings. General Expectations and Past Experiences: Possess a Bachelor's or Masters degree in Pharmaceutical Sciences, Chemistry, or a related field. Have 4-7 years of experience in a pharmaceutical QC lab, preferably API-focused. Demonstrate expertise in HPLC and GC, including troubleshooting and method validation. Exhibit a strong understanding of GMP, GLP, ICH, and pharmacopeial compliance. Proficiency in Empower CDS is essential. Strong skills in data review, OOS/OOT handling, CAPA, and documentation. Excellent team collaboration, problem-solving, and communication abilities.

We are looking for a meticulous Executive/Sr. Executive to spearhead regulatory submissions and review at Synnat Pharma Private Limited. In this pivotal role, you will be instrumental in ensuring our API manufacturing processes adhere to global pharmaceutical regulations. Your expertise will be essential in compiling, reviewing, and submitting comprehensive regulatory documentation to various health authorities, including the US FDA, EMA, and CDSCO. You will manage regulatory inspections, handle queries, and lead the preparation of DMF filings. The ideal candidate will possess a deep understanding of regulatory guidelines, ICH guidelines, and relevant pharmacopeias (USP, EP, BP), coupled with experience in process validation and variation submissions. Your responsibilities will extend to maintaining robust electronic document management systems (EDMS) and ensuring manufacturing records align with regulatory requirements. This position demands a proactive individual with excellent communication skills to effectively liaise with regulatory agencies and internal stakeholders, ensuring Synnat Pharma maintains its commitment to quality and compliance in the pharmaceutical industry. Job Details: Industry: Pharmaceutical (API Division) Department: Regulatory Affairs Role: Executive/Sr. Executive Location: Visakhapatnam Compensation: 5,00,000 - 10,00,000 INR per annum Experience: 5-9 years Qualification: Bachelor's degree in Pharmacy, Chemistry, or related field Responsibilities: R egulatory Submissions & Documentation: Prepare, review, and submit comprehensive regulatory dossiers and technical documentation for API products to various health authorities (US FDA, EMA, CDSCO). Manage the compilation, archiving, and tracking of all regulatory documentation using electronic document management systems (EDMS). Ensure all regulatory submissions are accurate, complete, and compliant with current regulatory guidelines and requirements. Maintain up-to-date knowledge of changes in pharmaceutical regulations and guidelines and communicate these changes to relevant stakeholders. Prepare and manage Drug Master File (DMF) filings, renewals, and updates, ensuring timely submissions and compliance. Coordinate with cross-functional teams (manufacturing, quality control, R&D) to gather necessary data and documentation. Regulatory Compliance & Inspections: Lead and manage regulatory inspections conducted by health authorities, ensuring preparedness and compliance. Develop and implement corrective and preventive actions (CAPA) in response to inspection findings and regulatory queries. Conduct internal audits to ensure compliance with pharmaceutical regulations and quality standards related to API manufacturing. Review manufacturing records and analytical data to ensure compliance with regulatory requirements and guidelines. Monitor and ensure adherence to pharmacopeias (USP, EP, BP) and ICH guidelines in API manufacturing processes. Maintain a thorough understanding of API manufacturing regulatory compliance. Regulatory Communication & Liaison: Act as the primary point of contact for communication with regulatory agencies regarding submissions, queries, and inspections. Prepare and manage responses to regulatory queries and deficiency letters, ensuring timely and accurate information. Liaise with internal stakeholders to address regulatory issues and provide guidance on compliance matters. Communicate regulatory updates and changes to relevant departments. Cultivate and maintain positive relationships with regulatory agencies. Provide support and guidance to cross-functional teams on regulatory expectations. Variation & Renewal Management Prepare and submit variation applications for changes to approved API manufacturing processes and formulations. Manage the renewal process for existing regulatory approvals, ensuring timely submissions and compliance. Assess the impact of proposed changes on regulatory filings and ensure appropriate documentation is prepared. Track the status of variation and renewal applications and communicate updates to stakeholders. Ensure all variations and renewals align with current regulatory guidelines. Maintain a comprehensive record of all variations and renewals submitted General Expectations and Past Experiences: Possess a Bachelor's degree in Pharmacy, Chemistry, or a related scientific field. Demonstrated experience (6-9 years) in regulatory affairs within the pharmaceutical industry, specifically in API manufacturing. Proven expertise in preparing and managing DMF filings and regulatory submissions for global health authorities (US FDA, EMA, CDSCO). Strong knowledge of pharmaceutical regulations, ICH guidelines, and pharmacopeias (USP, EP, BP). Experienced in regulatory inspections and responding to regulatory queries and deficiency letters. Proficient in EDMS and other relevant documentation systems. Excellent communication, interpersonal, and problem-solving skills with the ability to work cross-functionally.

Job description : Lead the preparation and review of aggregate safety, risk management, signal detection, and benefit-risk evaluation reports Demonstrate the ability to independently manage the production of safety deliverables, including those involving complex data analyses or important safety issues Act as a technical lead of the medical writing teams across projects and provide guidance and expertise for developing high-quality scientific content as required for various safety deliverables Establish good client communication and coordination within writing teams to manage stakeholder expectations and resolve any issues surrounding project/report deliverables Contribute to scientific publications and represent the company at scientific meetings and conferences Work with the project management team to implement quality and process improvement initiatives Foster excellent working relationships with all clients, both internal and external, with the highest quality of service in a cost-effective manner on time, every time. Summary of Responsibilities: Write and review various safety reports for global regulatory submissions for clients, including but not limited to Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Development Safety Update Report, Clinical Overviews, Medical Device reports, and other documents as assigned. Lead the end-to-end process of report production and ensure the required quality standards and key timelines are met. Provide oversight to co-authors or team of writers as applicable and be accountable for the quality of their work/contributions. Act as the primary point of contact for the client for all report management activities. Engage in client communication to manage stakeholder expectations, present anticipated challenges, propose remediation, and escalate unresolved issues impacting deliverables at an individual report or project level. Author/review RMPs, ad hoc reports, Benefit-Risk Evaluation reports, supporting documents for label updates, reports of effectiveness of risk minimization measures or enhanced pharmacovigilance activities. Lead/participate in various steps of the signal management process. Provide inputs for developing signal strategies and retrieval of data from safety databases, scientific literature, and other sources, as required. Author/review signal evaluation/management reports (ad hoc and periodic) and safety issue analysis reports. Participate in safety/benefit-risk review meetings with clients, discuss results and conclusions from signal/safety analysis, and in collaboration with the safety physician, propose label updates and other risk mitigation measures, as needed. Draft responses (or parts thereof) to health authority questions or feedback and collaborate with cross functional stakeholders in the management and tracking of such feedback. Develop abstracts, posters, manuscripts, and other documents for scientific publication or presentation at conferences or pharmacovigilance forums. Prepare medical information responses for HCPs. Act as a writing coach, provide regular quality feedback, conduct training, and share best practices with associates for promoting the use of clear and concise writing and adherence to style guides, as applicable. Support project management activities such as maintenance of project schedules and tracking of metrics and compliance. Contribute to business development activities, including estimation of resource requirement and responding to RFPs. Create and update labels, e.g. Core Data Sheets, USPI, centralized SPC s, Med Guides. Conduct literature reviews, formulate and execute search strategies, including those for complex topics or research questions. Implement and promote use of consistent, efficient, and quality processes to meet timelines and deliverables according to requirements and standard operating procedures and assume accountability for the deliverables. Ensure compliance of operations with governing regulatory requirements. Create, maintain, and assume accountability for a culture of high customer service. Perform any additional activities per project requirement or at the manager s discretion upon completion of relevant training. And all other duties as needed or assigned. Qualifications (Minimum Required): Minimum of first degree in life sciences (or equivalent). Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Experience (Minimum Required): At least 5-7 years of experience in the pharmaceutical industry, with at least 4 years of it in medical writing. Excellent command of written and spoken English. Good written and verbal communication skills. Knowledge of MS Office. Good organizational and time management ability. Excellent interpersonal and leadership skills. Scientific or clinical research or medical writing experience desirable. Good understanding of regulatory requirements, good Pharmacovigilance practices and ICH GCP guidelines.

We are looking DM RA with leading pharma company in Thane. Experience in Injectable regulatory affairs pre approval & post approval experience is must. Regulatory Submissions New Project Assignment This role involves the assignment and management of new projects for regulatory submissions, playing a pivotal part in the preparation and timely submission of high-quality regulatory documents across the US, EU, UK, and Emerging Markets. The position demands a strong understanding of global regulatory requirements, excellent communication skills, and effective cross-functional collaboration to ensure successful outcomes. Educational Qualifications Bachelor’s or Master’s degree in Pharmacy, Chemistry, or a related scientific discipline Diploma in Regulatory Affairs preferred Technical and Professional Expertise Demonstrated experience in regulatory affairs with a focus on submissions for the US, EU, UK, and Emerging Markets Solid understanding of ICH guidelines, ASEAN CTD requirements, and eCTD publishing standards Practical experience in the preparation, review, and submission of regulatory documents Familiarity with Quality by Design (QbD) principles and data trend analysis Experience 5 to 10 years of relevant experience in regulatory affairs Key Personal Attributes Excellent verbal and written communication skills Strong interpersonal and collaboration abilities Capable of working independently and managing multiple projects simultaneously Domain and Functional Competencies In-depth knowledge of international regulations (e.g., FDA, EMA, ICH) Up-to-date with evolving regulatory frameworks and compliance requirements Proficient in compiling,reviewing, and submitting comprehensive regulatory dossiers Ensures completeness, accuracy, and adequacy of all documents required for product approvals

Elevate Your Career with us, we're Seeking Masterminds to Drive Excellence! Evolet Healthcare Pvt. Ltd. is hiring for the position of Sr./Executive- Drugs Regulatory Affairs. Job Description: Having experience in dossier compilation (CTD & ACTD) for CIS, ASEAN, LATAM and AFRICAN countries. Controlling the whole process of registration products from the beginning till the end. Evaluation of Bioequivalence and Clinical Trials (preferably). Required Candidate profile: Having knowledge of ICH guideline with relevant 1-5 years of experience. Having experience in registration any CIS, ASEAN, LATAM and AFRICAN countries. To be flexible for travelling and meeting with manufacturing plant representatives, which located out station. Must have excellent communication skills Must have excellent in analyzing skills Excellent in accuracy and focus Self-motivated and enthusiastic Perks and Benefits: Health Insurance Shuttle facility, Fix office timing, Career growth training & development

Job Description We are looking for a dedicated and enthusiastic individual to join our Analytical Development team. The ideal candidate will contribute to maintaining high-quality standards in analytical research and support the development of safe and effective pharmaceutical products for global markets. This role offers hands-on experience in method development, validation, and regulatory documentation within a dynamic R&D environment. RESPONSIBILITY : Assisting to Team leaders, Research Scientists of Analytical Development departments on Research work and daily basis activity. Work towards Analytical development, Validation, Transfer activities of oral solids, Oral Liquids, Parenteral and semisolid products for Regulatory & ROW markets. Responsible to assist the major activity like Analytical method development, Routine and Stability sample Analysis, Method Verification/Validation and Method Transfer Activities. Conduct all Analytical activities associate with Research Scientist and seniors. Maintain good Hygiene, Clean of Laboratory and Follow Good Laboratory Practices. Scientific literature Search for strategic development towards Analytical developments. Review and summarizing technical data for milestone achievements. Responsible for Preparation of Analytical Reports like protocols, reports and other documentations, Maintain Quality documents of overall R&D Documentation Practices. Maintain Analytical Laboratory Note book during Analysis. Should be conversant of the ICH guidelines for stability studies of products and formulations. Accountable for the safety of Analytical Laboratory including maintenance of an effective Chemical Hygiene Plan. Accountable for SOP preparation of Analytical Instruments and GLP Procedures. Accountable of Maintance and proper storage of Laboratory chemicals, reagents, standards, impurities and other articles. Maintain Evolet Healthcare Policy on Quality, Saftey and Efficacy Value. Candidate Requirements: Qualification : M. Pharmacy or PhD in Pharmaceutics or related field Experience : 0 to 2 years in Research Associate (Analytical & Development) Communication Skills : Excellent verbal and written communication skills in English Attributes : Positive attitude, willingness to learn, and a proactive approach to research work

We are looking for passionate and motivated individuals with an M. Pharmacy or PhD qualification to join our dynamic Research & Development team as a Research Associate (Formulation & Development). As a Research Associate, you will be actively involved in formulation development for various dosage forms, supporting scientists in innovative pharmaceutical research for both regulatory and ROW markets. Job Description: Assisting to Team leaders, Research Scientists of Formulation & Development on Research work and daily basis activity. Work towards formulation development of oral solids, Liquids, Parenteral and semisolid products for Regulatory & ROW markets. Conduct product development activity associate with Research Scientist and seniors. Conducting Experimental Trials, and maintain daily basis documentation on Research Activity. Maintain good Hygiene, Clean of Laboratory and Follow Good Laboratory Practices. Scientific literature Search for strategic development towards formulation developments. Maintenance and Reconciliation of All API, RM, PM and R&D Store Materials. Provides support in scale up/Technology transfer activities for new Formulation development Projects. Assisting and ensuring timely completion of development activities at in-house R&D lab, (Pre-formulation studies, formulation development, stability studies etc.) Review and summarizing technical data for milestone assessments. Preparation & Reviewing of formulation development protocols, reports and other documentations, Maintain Quality Documents of overall R&D Documentation Practices. Maintain Laboratory Note book during conducting trials. Should be conversant of the ICH guidelines for stability studies of products and formulations. Candidate Requirements: Qualification : M. Pharmacy or PhD in Pharmaceutics or related field Experience : 0 to 2 years in Formulation & Development or related R&D activities Communication Skills : Excellent verbal and written communication skills in English Attributes : Positive attitude, willingness to learn, and a proactive approach to research work Technical Understanding : Basic knowledge of formulation development processes and good laboratory practices (GLP) is desirable