117 Ich Guidelines Jobs - Page 4

As a Clinical Research Associate II based in Shanghai, your role at Syneos Health will involve performing various site management activities to ensure regulatory compliance and protocol adherence. You will play a crucial role in evaluating site performance and providing recommendations to the project team while promptly addressing any serious issues that may arise. Your responsibilities will include conducting site qualification, initiation, monitoring, and close-out visits either on-site or remotely. Ensuring the proper process of obtaining informed consent from subjects/patients, safeguarding confidentiality, and assessing factors that may impact safety and data integrity will be key aspec...

As a Senior Regulatory Associate (CMC) at Syneos Health, you will play a crucial role in ensuring regulatory compliance by leveraging your practical understanding of ICH guidelines, GMP requirements, and regional regulatory frameworks such as FDA and EMA. Your responsibilities will include preparing, compiling, reviewing, and submitting high-quality CMC dossiers for variations, renewals, annual reports, and RTQs. In this dynamic role, you will be expected to support change control assessment and impact assessments for global markets, as well as execute day-to-day tasks according to client processes and SOPs to build high-quality global CMC dossiers. Additionally, you will be involved in trai...

Test raw materials and products using HPLC, GC, UV, IR, and KF. Maintain reports, COAs, and compliance records. Support OOS/OOT checks and stability studies. Calibrate instruments and ensure lab safety. Required Candidate profile Qualification: B.Sc / M.Sc (Chemistry/Pharma), B.Pharm / M.Pharm, Chemical ER. Fresher or 2–3 years of experience in QC. Strong knowledge of analytical techniques, regulatory guidelines.

Ensure compliance with GMP, GLP, SOPs in manufacturing, testing. Prepare, review quality documents, deviations, and change controls. Conduct in-process checks, line clearance, & batch record reviews. Coordinate with teams and ensure audit compliance. Required Candidate profile B.Sc / M.Sc / B.Pharm / M.Pharm in Chemistry or related field. Fresher or 1–3 years of QA experience in Pharma preferred. Strong knowledge of GMP, GLP, and regulatory guidelines.

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 ...

You are an Executive with 3-5 years of experience in API - Pharma Production Department. Your role involves managing day-to-day production operations to ensure optimal utilization of materials, equipment, and personnel. It is crucial to uphold full compliance with Good Manufacturing Practices (GMP), ICH guidelines, and regulatory requirements from FDA and EMA. Your responsibilities include maintaining accurate documentation of all production activities, such as batch records, deviations, and related reports. You are expected to drive continuous improvement through Lean Manufacturing and Six Sigma methodologies. Additionally, you will actively participate in new product introductions and tech...

We are looking for a meticulous Senior Executive or Assistant Manager to lead regulatory filings at Synnat Pharma Pvt Ltd, a rapidly expanding company in the Active Pharmaceutical Ingredient (API) industry. In this pivotal role, you will be instrumental in navigating the complex landscape of pharmaceutical regulations, ensuring our API products meet the stringent requirements of global regulatory bodies, particularly the US FDA. Your expertise will be crucial in preparing and submitting Drug Master Files (DMFs) and eCTD-compliant documentation, managing regulatory inspections, and proactively mitigating regulatory risks. You will collaborate closely with API manufacturing, quality control, a...

Looking for Executive with 3-5 years experience in API - Pharma Production Department. Job Description 1. Managing day-to-day production operations while ensuring optimal utilization of materials, equipment, and personnel. 2. Ensuring full compliance with Good Manufacturing Practices (GMP), ICH guidelines, and applicable regulatory requirements including those set by the FDA and EMA. 3. Maintaining accurate and complete documentation of all production activities, including batch records, deviations, and related reports. 4. Driving continuous improvement initiatives by applying Lean Manufacturing and Six Sigma methodologies. 5. Actively participating in new product introductions and technolog...

You are currently recruiting for a Principal Scientist, R&D Analytical at Kenvue. At Kenvue, you understand the extraordinary power of everyday care and are built on a rich heritage of over a century, rooted in science. As the house of iconic brands like NEUTROGENA, AVEENO, TYLENOL, LISTERINE, JOHNSONS, and BAND-AID, science is your passion and care is your talent. The global team at Kenvue consists of approximately 22,000 brilliant individuals, fostering a workplace culture where every voice is valued, and each contribution is recognized. Passionate about insights and innovation, you are dedicated to delivering top-notch products to customers. As a Kenvuer, you have the power to impact mill...

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. The company is dedicated to transforming innovative science into medical solutions that provide value and hope to patients and their families. By focusing on addressing unmet medical needs and upholding ethics and integrity in business practices, Astellas strives to enhance the health of individuals globally. This particular position is based in Bangalore, India, and emphasizes the significance of work-life balance. Astellas believes in creating an optimal work environment that fosters productivity for all employees, promoting success and achievement. The primary purpose and scope...

You are invited to join ARDEM Data Services Private Limited as a Medical Data Entry professional for patient records with a minimum of 1 year of experience in medical data annotation and document review. The ideal candidate should have a background in medical or pharmaceutical sciences and possess essential skills related to medical data management, regulatory guidelines (FDA, EMA, ICH, GCP), and patient report handling. This role requires prior experience working night shifts and is a permanent work-from-home position. Key Responsibilities - Review and annotate medical documents and patient records accurately. - Apply knowledge of FDA, EMA, ICH, and GCP guidelines to data management tasks. ...

Deputy General Manager Human Resources (Plant & R&D) Location: Ahmedabad, Bhat Reporting to: General Manager HR (or CHRO) Position Overview (Role Purpose) A dual-sphere HR leader responsible for the seamless execution of all human resource functions across the manufacturing plant, the R&D center (analytical, formulation, clinical, bioassay, regulatory affairs, pharmacovigilance). Acts as a strategic HR Business Partner to R&D leadership, aligning people plans with business drive, statutory compliance (including cGMP/ICH norms), talent strategy, and organization capability. Key Accountabilities & Responsibilities Plant HR (R&D) Provide strategic HR business partnership to Plant/site leadershi...

We are seeking a Technology Transfer team member to support the development and implementation of robust manufacturing processes, including authoring validation protocols and reports, conducting risk assessments, and utilizing advanced tools for process monitoring and analysis. Your role will involve active participation in technology transfers, continuous improvement initiatives, and ensuring compliance across manufacturing operations. Roles & Responsibilities Responsible for Validation which shall include:Preparation/Review/Approve of MPR.Preparation/Review/Approve of process validation protocols. Preparation/Review/Approve & compilation of validation report. Responsible for Tech transfer ...

The ideal candidate for this role should possess a minimum education qualification of M. Pharmacy. You will be responsible for handling regulatory activities such as CTD dossier preparation, query resolution, and ensuring compliance with ICH guidelines and current regulatory standards. Your primary market focus will be on the Africa market, specifically in regions like Zazibona, South Africa, East Africa (Kenya, Tanzania, Ethiopia, etc.), and FWA. Your key responsibilities will include: - Preparation and submission of new dossiers - Conducting gap analysis of dossiers for completeness - Compiling dossiers in eCTD format for submission to various regulatory authorities - Coordinating dossier ...

As the PV Operations & Safety Systems Lead in Pharmacovigilance at Biocon Biologics, you will be part of a pioneering company dedicated to revolutionizing healthcare. With a focus on patient-centricity, affordable innovation, and disruptive thinking, our goal is to impact a billion lives globally. At our multicultural organization, you will collaborate closely with partners and patients, working towards the shared vision of providing high-quality, affordable biosimilars to individuals worldwide. Reporting to the Head of Pharmacovigilance, your role will involve overseeing Pharmacovigilance operations and PV Systems functions within the Clinical Development and Medical Affairs department. You...

As a Safety & PV Specialist I at Syneos Health, based in the Pune Office, you will play a crucial role in ensuring the safety and pharmacovigilance of our products. Your primary responsibility will be to enter information into PVG quality and tracking systems for the receipt and tracking of ICSRs. Additionally, you will assist in the processing of ICSRs according to SOPs and project-specific safety plans. In this role, you will triage ICSRs, evaluate the data for completeness and accuracy, and ensure regulatory reportability. You will enter data into the safety database, code events, medical history, concomitant medications, and tests, and compile complete narrative summaries. Your attention...

As a Senior Medical Writer at Syneos Health, you play a vital role in leading the clear and accurate completion of medical writing deliverables. Your responsibilities include managing medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision. You will be responsible for completing various documents such as clinical study protocols, reports, patient narratives, annual reports, and more. Adhering to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, and client standards, is essential. Your role involves coordinating quality and editorial reviews, ensuring...

Date: 2 Jul 2025 Location: Bangalore, KA, IN, 560099 Custom Field 1: Dedicated Centre Job Description Designation: Research Associate (9-I) or Senior Research Associate (9-II) Job Location: Bangalore Department: BBRC PD ARD GMP About Syngene Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development, and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical industries worldwide. Syngenes clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA, and Herbalife. Its innovative culture is driven by t...

At Quanticate, we&aposre pioneers in providing top-tier statistical and data management support to our clients. We&aposre seeking a dedicated "Clinical Data Manager I" who&aposs committed to upholding the highest standards, following procedures, and ensuring compliance with regulations, all while providing exceptional customer care. As a "Clinical Data Manager I" you will lead, co-ordinate, and action all tasks relating to Clinical Data Management from the start to the finish of a study & to project manage studies across CDM functions. Core Accountabilities: Activities required of a Clinical Data Manager I (however not restricted to) are as below: To contribute to the efficient running of th...

Skill required: Regulatory Services - Life Sciences Regulatory Operations Designation: LifeScience Regulatory Svs Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more...

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The Project Lead Pharmacovigilance position at DDReg offers a compelling opportunity for you to advance your career in pharmacovigilance project management. As a crucial member of the Project Management team, you will play a key role in overseeing and directing all pharmacovigilance services. Your responsibilities will include serving as the primary contact for clients, ensuring project activities align with client needs and regulatory requirements, and maintaining high-quality work standards to achieve client satisfaction. Your key accountabilities in this role will involve closely managing client relations by acting as the main liaison between clients and project teams. You will be respons...

You have proven experience working in GMP/GLP and scientific environments. You possess basic knowledge of Spectroscopic and Biophysical techniques, Peptide chemistry, as well as peptide characterization. Your expertise lies in at least one of these subjects. Additionally, you have experience in related compound method development and method validation for Peptide drug products using LC-UV and Amino acid analyzer. Hands-on experience with SEC-UV SEC-MALS, SV-AUC, CE, and data interpretation is also one of your strengths in at least one of the techniques and data interpretation. You are skilled in the preparation and review of method development and method validation reports. Knowledge of ICH ...

You will be responsible for liaising between various departments such as Planning, Production, Technical Services, Marketing, and Exports. Your roles and responsibilities will include the preparation, review, and implementation of SOPs and STPs. You will be checking all QC related records like analytical reports and logbooks. Additionally, you will be involved in planning and distributing samples for the analysis of Raw Materials, Intermediates, and finished products. You will design and conduct Stability studies as per ICH Guidelines and develop and validate analytical testing methodology used to control raw materials, production intermediates, and final products. Your tasks will also inclu...

As a Medical Writer II (Clinical Trial Transparency) at Syneos Health, you will play a crucial role in compiling, writing, and editing medical writing deliverables. Your responsibilities will include mentoring less experienced medical writers, developing various documents such as clinical study protocols, clinical study reports, patient narratives, annual reports, and investigator brochures with minimal supervision. You will review statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency. Collaboration with department heads and staff in data management, biostatistics, regulatory affairs, and medical affairs will be essential to produce ...