168 Ich Guidelines Jobs

Job Description You will be the dynamic and experienced Team Lead in Global Regulatory Affairs - API team at Dr. Reddys Laboratories Ltd. Your primary role will be to provide guidance and support to the team in their operations. You will need to offer guidance on product & region-specific regulatory requirements to the development team for new products & life cycle management activities planned at manufacturing sites. Additionally, you will provide prompt regulatory support to the customers and review regulatory submissions to ensure new submissions align with the scorecard commitments. It will be your responsibility to ensure timely responses to deficiencies received from regulatory agencie...

As a Stability Study Manager, your role involves managing and overseeing stability study processes to ensure compliance with regulatory requirements and maintain the integrity of stability data. You will coordinate stability analyses, handle audits, and support quality management systems (QMS) to uphold the highest standards of quality and compliance. Key Responsibilities: - Coordinate with the Quality Control team for stability analysis and retrieval of stability data. - Prepare stability study protocols and conduct gap assessments in stability analysis. - Arrange stability samples and conduct daily reviews of temperature and relative humidity (RH) printouts. - Provide stability data for re...

Who We Are Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with. Th...

Role Overview: At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. As a Sr. Clinical Research Associate Contractor (SrCRA) at Allucent, you will independently control and monitor investigational sites, proactively detect issues, and provide solutions to ensure clinical studies are conducted according to the trial protocol and in compliance with SOPs, applicable regulations, and the principles of Good Clinical Practice. Key Responsibilities: - Govern highest possible quality standards for trial monitoring activities. - Conduct all study...

Job Description Business: Piramal Pharma Solutions Department: Global Procurement / Supply Chain Location: Kurla (with global responsibilities across all manufacturing sites for strategic procurement) Travel: Medium Job Overview The Global Procurement Strategy & Category Leadership will lead procurement strategy, sourcing operations, and supplier partnerships for all direct materials including APIs, excipients, intermediates, and packaging components across multiple global sites. This is a strategic and data-driven leadership role that combines deep domain expertise in pharmaceutical procurement with strong global market insight, vendor management, and digital transformation capabilities. Th...

Do you want to be part of an inclusive team that works to develop innovative therapies for patients Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For...

Job Title: Assistant Manager - Quality Management System (Analytical Assurance) Experience in Analyticaal QA is must to this role. 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 8 to 10 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 T...

Role Overview: As the Director of Real World Statistics, you will focus on applying advanced statistical methodologies to support a rare disease portfolio, with a strong emphasis on disease registry initiatives and regulatory submissions. This role sits within a dedicated Real World Evidence (RWE) capability that combines deep statistical expertise with extensive experience in regulatory applications. We are seeking a curious, driven, and detail-oriented leader with proven experience in disease registries and longitudinal observational cohorts. You will provide statistical leadership, mentor junior statisticians, and deliver high-quality analyses aligned with regulatory standards. Key Respon...

Role Overview: You will assist in writing, editing, and compiling written deliverables in the disciplines of chemistry, manufacturing, and controls (CMC), nonclinical, clinical, medical, and regulatory for submission to regulatory agencies at Allucent Regulatory Consulting. As an Associate Medical Writer, you will develop skills in scientific discussions related to the planning, production, and review of written deliverables. Additionally, you will be a member of the medical writing staff. Key Responsibilities: - Assist with writing, editing, and compiling written deliverables in various disciplines for submission to regulatory agencies, sponsor use, or for publication - Contribute to scient...

The Senior Study Grant Analyst position in the Grants Strategy Team (GST) within Launch Excellence department is a highly varied and challenging role, suitable for an individual with both in-depth business operational process experience, global understanding of healthcare compliance, expertise in the development of Clinical Site budget and grants and aptitude for technology optimization and implementation. The role is accountable for Grants estimates delivery of their respective portfolio of client partners and ensuring alignment to delivery of commitments, within the agreed expectations, including alignment to operational processes. Leverage actual PXL portfolio data for a more comprehensiv...

Role Overview: As a Scientist at USP, you will play a crucial role in conducting analytical tests on Verification samples (Dietary supplements/Dietary Ingredients) using suitable methods. Your expertise will enhance the laboratory's scientific proficiency and work ethic by providing technical support and knowledge. You will be proficient in various laboratory techniques and capable of offering valuable observations and insights into challenging projects. Your responsibilities will include executing analytical tests, preparing summary reports, and contributing to the Verification Program. Key Responsibilities: - Conduct verification projects on Dietary Supplements/Dietary Ingredients by perfo...

Role Overview: As a Scientist at USP, you will be responsible for conducting necessary analytical tests on Verification samples (Dietary supplements/Dietary Ingredients) using suitable methods. Your role will involve enhancing the laboratory's scientific proficiency and work ethic by providing extensive technical support and knowledge. You will be proficient in various common laboratory techniques, offering valuable observations and insights into challenging projects. Your primary responsibility will be to provide technical aid to the Verification Program by executing analytical tests and preparing comprehensive summary reports. Key Responsibilities: - Conduct verification projects on Dietar...

As a Drug Regulatory Affairs Specialist, you will play a crucial role in developing and implementing regulatory strategies to bring drugs to market in compliance with relevant laws and regulations. Your responsibilities will include conducting regulatory research, providing guidance on regulatory issues, and preparing and submitting applications and regulatory submissions such as INDs, NDAs, and BLAs. You will also be tasked with communicating with regulatory agencies, managing projects and timelines, and collaborating with cross-functional teams to ensure regulatory compliance throughout the product development process. It is essential for you to stay informed of regulatory changes and tren...

Role Overview: As a Statistical Programmer I at our company, you will be an integral part of the Biostatistics and Statistical Programming project team, supporting the Lead Statistical Programmer in developing programs for the statistical analysis and reporting of projects. Your primary responsibilities will include creating, testing, and maintaining programs for clinical studies under the guidance of senior programmers. Additionally, you will be involved in generating summary tables, data listings, graphs, and derived datasets using SAS as per the statistical analysis plan and programming specifications. Key Responsibilities: - Utilize SAS to generate summary tables, data listings, graphs, ...

As a Safety & PV Specialist I (Japanese Language Expert) at Syneos Health, your role will be crucial in ensuring the safety and well-being of patients involved in clinical trials and post-marketing programs. Here is a detailed overview of your responsibilities: - Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required. - Assist in processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans. - Triage ICSRs, evaluate data for completeness, accuracy, and regulatory report ability. - Enter data into safety database and code events, medical history, concomitant medications, and tests. - Compile complete ...

Job Responsibilities To ensure the daily operations of analytical lab in ARD Department. Responsibility to analytical method development, validation, and routine testing. Manage release and stability testing of raw materials, in-process, and finished products on time. Preparation of validation protocols and reports as per USFDA, EMA and ICH guidelines. Ensure the lab instrument calibrations and maintenance as per the in-house protocol. Responsible for implementation of GLP activities in ARD lab. Responsibility to verify the all log books on daily basics. Preparation standard operating procedures in ARD Lab. Responsibility to ensure the sample management system in ARD Lab. Responsibility to e...

Role Overview: As an Analyst - Quality Assurance (Analytical Quality Assurance) at Immuneel, you will be responsible for in-process and batch QC activities. You will collaborate with internal QA, manufacturing, quality control, facilities operations, environmental health safety, and regulatory departments to ensure Analytical QA requirements are met and compliant with cGMP standards. Key Responsibilities: - Conduct Analytical Quality Assurance and development quality assurance tasks. - Review specifications, STP & ATR of raw material, packaging/consumable material, in-process, DS, DP finished product, and stability samples. - Review Certificates of Analysis (CoA) for various materials and pr...

Description Safety & PV Specialist I Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innov...

As a Safety & PV Specialist I-Japanese at Syneos Health in Pune Office, your primary responsibility will be to ensure accurate and timely processing of Individual Case Safety Reports (ICSRs) in compliance with Standard Operating Procedures (SOPs) and regulatory requirements. You will play a crucial role in maintaining safety tracking, performing data entry into safety databases, coding events and medical history, and compiling narrative summaries. Additionally, you will be involved in the validation and submission of xEVMPD product records, management of duplicate ICSRs, and activities related to SPOR / IDMP. Key Responsibilities: - Ensure accurate and timely processing of Individual Case Sa...

Job Description Job Description Prepare, Review and Approval of COA. Review and Approval of stability protocols, reports, and summary reports. Prepare justification for reduction of tests for Input material testing such as raw and packaging material; In-process testing; Finished product testing; Stability testing; Microbial testing. Prepare and review of specification/Method of analysis. Initiation, evaluation of Change control. Review of vendor qualification documents. Handling of item codification. Technical Skill Required Analytical documentation : Advanced ICH Guidelines : Advanced Stability Management : Advanced QMS Automation System : Intermediate US Guidelines : Advanced Qualification...

As a QA Docscell at our company, your role involves ensuring compliance with cGMP, ICH guidelines, and regulatory requirements. You will be responsible for reviewing and maintaining batch manufacturing records (BMRs), batch packaging records (BPRs), and quality documentation. Additionally, you will conduct in-process checks and line clearance during manufacturing and packaging activities. Your responsibilities will also include participating in internal audits, self-inspections, and external regulatory audits. You will review and assist in the preparation of SOPs, protocols, and reports. In case of deviations, CAPA, change controls, and OOS/OOT results, you will investigate and document them...

About Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products. For more information visit: www.apotex.com. Job Summary Responsible for the coordination of the pre-marketed stability program within Global R&D, and for the preparation and review of stability data evaluation reports (e.g., Executive Stabi...

Role Overview: As a member of the team at Amneal, you will be responsible for preparing, reviewing, and approving Certificate of Analysis (COA) and stability protocols, reports, and summary reports. You will also play a key role in justifying the reduction of tests for various types of material and testing as well as handling item codification. Your expertise in analytical documentation, ICH Guidelines, Stability Management, QMS Automation System, and US Guidelines will be crucial for success in this role. Key Responsibilities: - Prepare, review, and approve Certificate of Analysis (COA) - Review and approve stability protocols, reports, and summary reports - Justify reduction of tests for v...

Key Responsibilities: 1. Develop the global regulatory strategies for biologic products across all development phases (preclinical to post-marketing) for the (US, EU, and ROW). 2. Ensure alignment with business goals and regulatory requirements across the different regions. (FDA, EMA, emerging markets). 3. Prepare, review, and manage high-quality regulatory submissions including INDs/IMPDs, BLA/MAA, CTA, DSUR, Annual Reports, as applicable. 4. Post-approval changes (variations, amendments). 5. Liaise with global regulatory agencies to facilitate product approvals and resolve queries. 6. Collaborate with R&D, Quality, Clinical, and national regulatory teams to ensure regulatory compliance acr...

As a Senior Manager of Benefit Risk Assessment Operations at Bristol Myers Squibb, you will be responsible for collaboratively authoring and revising key drug safety-focused documents to support upcoming submission documents to Regulatory Health Authorities worldwide. Your role will involve working closely with various cross-functional stakeholders in BMS to prepare accurate and concise safety information for the development of new treatments and post-marketing safety activities. **Principal Responsibilities:** - Attend meetings related to structured benefit risk assessment (SBRA) to understand approaches and contribute to discussions. - Schedule and facilitate meetings to discuss risk manag...