54 Ich Guidelines Jobs

As a Safety Specialist I at Precision, your role will involve performing all aspects of the collection, processing, and reporting of individual cases safety reports (ICSR) for clinical trials and/or post-marketing safety programs. Key Responsibilities: - Process ICSRs following Standard Operating Procedures (SOPs) and project/program-specific safety plans - Triage ICSRs, evaluate data for completeness, accuracy, and regulatory report ability - Enter data into Argus Safety Database - Code events, medical history, concomitant medications, and tests - Draft case narratives - Assess information to be queried and follow up until queries are satisfactorily resolved - Generate timely, consistent, a...

Description 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 ru...

You are a detail-oriented RA-CMC Associate responsible for supporting end-to-end submissions for global markets. Your expertise includes Lifecycle Management (LCM), Veeva Vault RIM, and managing complex Initial and Variation submissions. Your key responsibilities will involve preparing Variation documents and/or evaluating post-approval CMC changes to ensure compliance with global regulatory requirements. You will play a significant role in Lifecycle Management (LCM) activities by assisting in compiling and reviewing CTD dossier modules. Your tasks will also include compiling initial dossiers (Modules 2 & 3) for various countries such as US, EU, SA, WHO, ANZ, and others. You will be expected...

At EY, you'll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture, and technology to become the best version of you. And we're counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. As part of our EY-ER- Regulatory Compliance team, you will help clients by understanding their business needs and translating their strategies into realities through innovation. As a Regulatory Compliance Associate Director, you will actively establish, maintain, and strengthen internal and external relationships. In line with our commitment...

Job Title: Regulatory Affairs Specialist Med/Pharma (Female) Location: Remote Position Overview: We are seeking an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring compliance with applicable regulations (FDA, EMA, CDSCO, MHRA, ISO 13485, ICH guidelines). The ideal candidate will have a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and commercialization. Key Responsibilities: Prepared, reviewed...

We are seeking an experienced and detail-oriented Medical Reviewer to join our team. The role involves reviewing, analyzing, and ensuring accuracy, consistency, and compliance of medical and scientific content in alignment with regulatory, clinical, and organizational standards. Key Responsibilities Review medical, clinical, and regulatory documents for scientific accuracy, clarity, grammar, and compliance. Ensure consistency of terminology, data, and style across all documents. Validate clinical and safety data in reports and submissions against source documents. Collaborate with cross-functional teams including medical writers, clinical research, and regulatory affairs. Provide feedback an...

The role of Line Manager at the company involves overseeing and managing the Performance and Safety Services (PSS) staff, including conducting performance reviews, handling human resource issues, and collaborating with Senior PSS Management on resource allocation for projects. The primary responsibility of the Line Manager is to provide guidance and support to junior PSS staff members. This includes managing, coordinating, and supervising PSS operations related to adverse events and expedited safety reports to ensure compliance with standards and timely submission to clients and regulatory agencies if required. The Line Manager is also expected to support team members in delivering high-qual...

The Technology Transfer Associate is responsible for coordinating and executing the seamless transfer of pharmaceutical products to Ritsa manufacturing Facility from client /R&D or result in any merger or acquisition. This role will oversee the planning, execution, and completion of projects with end-to-end accountability for deliver in time This role ensures that all processes (analytical and manufacturing) are effectively transferred while maintaining compliance with regulatory requirements, quality standards, and operational efficiency. Key Responsibilities: Project Planning and Execution Define project scope, objectives, deliverables, and timelines. Develop detailed project plans, alloca...

As a Product Development Scientist at our company, you will be responsible for executing lab batches for Solid Orals and liquid orals, which includes formulation strategy, process selection, drug excipients compatibility, lead formulation selection, stability studies, and tech transfer in accordance with applicable regulations and ICH guidelines. You will also play a key role in advancing new formulations from idea generation through development and scale-up. Your primary task will involve evaluating and implementing ICH and Quality by Design (QbD) concepts during the Product development phase. This includes considering elements such as Quality Target Product Profile (QTPP), Critical Quality...

As a LifeScience Regulatory Services Associate at Accenture, you will be a part of the Life Sciences R&D vertical, offering services ranging from research laboratories, clinical trials support, regulatory services, to pharmacovigilance and patient services solutions. Your role will involve performing regulatory affairs LCM with Veeva skill set of submission in accordance with ICH guidelines and other Health Authorities. You will review and transform Source Documents, conduct Quality Control (Document QC) checks for all submission components, and collect, collate, and evaluate the scientific data gathered as part of R&D. Additionally, you will advise on legal and scientific restraints and req...

The responsibility of this role is to provide all clients, both internal and external, with high-quality service in a safe and cost-effective manner. You are expected to adhere to legal requirements such as the Health and Safety at Work Act 1974, COSHH regulations 1989, and EC Directives 1992/3 as outlined in the Company's Health and Safety Manual. Your key responsibilities include: - Conducting quality reviews of assigned cases. - Compiling quality metrics based on reviews and identifying trends. - Assisting in client quality reviews and preparing corrective and preventive actions. - Ensuring implementation of CAPA results in coordination with project managers. - Reviewing various cases and...

Are you seeking a rewarding career in Project Management within the Clinical Research industry Join Clario's Medical Imaging team in Bengaluru, India, and become a part of a legacy with over 30 years of expertise. Clario specializes in offering seamless, secure, and compliant medical imaging solutions that enhance clinical trials. At Clario, we have set ambitious goals and have a clear vision for the future. This is your opportunity to be a part of our journey as a Clinical Project Manager. What we offer: - Competitive compensation - Attractive benefits including security, flexibility, support, and well-being - Engaging employee programs - Technology for hybrid working and great onsite facil...

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 ...