731 Ich-Gcp Guidelines Jobs - Page 7

Roles and Responsibilities: The individual will be responsible for overseeing end-to-end compliance for both Indirect and Direct Taxes for multiple countries. This role will be reported directly to the Tax Operations Delivery Manager. Seeking a detail-oriented and proactive Tax Operations Specialist/Sr. Specialist to support the accurate and timely execution of tax-related processes across our organization. This role involves managing tax documentation, ensuring compliance with regulatory requirements, supporting tax reporting, and collaborating with internal and external stakeholders to streamline operations. Tax Documentation & Compliance Maintain and validate tax documentation Ensure comp...

The Associate pharmacovigilance specialist performs pharmacovigilance services such as biomedical literature monitoring and assessing for adverse events reporting, indexing, and abstracting by using broad knowledge of scientific terms and medical terminology, drugs and therapeutic areas, and pharmacovigilance regulations. About You - Education, Experience, Skills Masters Degree in life Sciences, Health, or Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics etc.). A degree in Dentistry/physiotherapy/Nursing, which involves patient exposure in hospital-based environment, would be an advantage. At least 1-2 years of experience reviewing biomedical literature fo...

Responsibilities: Analytical Operations: Perform and supervise analysis of Raw Materials (RM), Packing Materials (PM), and Finished Goods (FG). Operate and maintain analytical instruments :- HPLC, GC, UV-Vis, FTIR, Dissolution Apparatus Ensure compliance with GLP, 21 CFR Part 11, and data integrity standards. Review and approve analytical reports and LIMS entries , Quality Systems & Compliance Implement and monitor Quality Management Systems (QMS). Lead investigations for OOS, OOT, Deviations, and Laboratory Incidents. Prepare and review SOPs, STPs, and validation protocols. Ensure audit readiness and support regulatory inspections (USFDA, WHO-GMP, etc.) Documentation & Reporting Maintain ac...

This Position reports to: Delivery Manager-Tax Operations Roles and Responsibilities: The individual will be responsible for overseeing end-to-end compliance for both Indirect and Direct Taxes for multiple countries. This role will be reported directly to the Tax Operations Delivery Manager. Seeking a detail-oriented and proactive Tax Operations Specialist / Sr. Specialist to support the accurate and timely execution of tax-related processes across our organization. This role involves managing tax documentation, ensuring compliance with regulatory requirements, supporting tax reporting, and collaborating with internal and external stakeholders to streamline operations. Tax Documentation & Co...

About The Role Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy Years of Experience: 1 to 3 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to i...

About The Role Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy Years of Experience: 1 to 3 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to i...

About The Role Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy Years of Experience: 1 to 3 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to i...

About The Role Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy Years of Experience: 1 to 3 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to i...

About The Role Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy Years of Experience: 1 to 3 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to i...

About The Role Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy Years of Experience: 1 to 3 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to i...

About The Role Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy Years of Experience: 1 to 3 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to i...

About The Role Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy Years of Experience: 1 to 3 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to i...

About The Role Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy Years of Experience: 1 to 3 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to i...

We are looking for a skilled Income Auditor to join our team, with 3-6 years of experience in the hospitality industry. The ideal candidate will have a strong background in auditing and financial analysis. Roles and Responsibility Conduct audits to ensure compliance with financial regulations and standards. Analyze financial data to identify trends and areas for improvement. Develop and implement audit plans and procedures. Collaborate with cross-functional teams to resolve audit findings. Prepare and present audit reports to management. Identify and mitigate risks associated with financial transactions. Job Requirements Strong knowledge of accounting principles and financial regulations. Ex...

ABOUT AMGEN Roles & Responsibilities: Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, or prepare documents for public registries e.g. ClinicalTrials.gov Work closely with cross functional stakeholders to define redaction strategy and disclosure, lead review and approval, ensure submission readiness, and hand off for timely submission or posting Ensure consistent quality across documents, ensure submission readiness, and hand off for timely submission or posting Communicate with team members or cross-functional stakeholders to resolve problems and escalate issues Record and maintain w...

Roles & Responsibilities: Lead the preparation of clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with applicable regulations, guidance, and company requirements Work closely with the transparency and disclosure team and with cross functional stakeholders to define redaction strategy, to ensure timely and accurate registration and results review/approval process, including the redaction process, for US and EU registries, lead cross functional review and approval, ensure submission readiness, and hand off for timely submission or posting Support trend analysis and continuous improveme...

Roles & Responsibilities: Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with regulatory requirements and the agreed strategy defined by the cross functional team Ensure consistent quality across documents, ensure submission readiness, and hand off for timely submission or posting Collaborate with team members to resolve problems and escalate issues Record and maintain written redaction strategy for the study and product Manage timelines and coordinate work across team Execute clinical trial disclosure business process and ensure deliverables and delivery timelines in compli...

Role description: Amgen is seeking a Regulatory Affairs Associate Director supporting lifecycle management for approved, mature products across all Amgen Therapeutic Areas. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and life cycle management of all Amgen molecules. In this important, product-facing role you will lead assigned Global Regulatory Teams (GRT) in the Regulatory Affairs organization. The role of the Regulatory Affairs Associate Director is to lead GRTs within Amgens GRAAS organization, develop a comprehensive regulatory strategy that takes into account worldwide regulatory requirements, maintai...

Roles & Responsibilities: Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with regulatory requirements and the agreed strategy defined by the cross functional team Ensure consistent quality across documents, ensure submission readiness, and hand off for timely submission or posting Collaborate with team members to resolve problems and escalate issues Record and maintain written redaction strategy for the study and product Manage timelines and coordinate work across team Execute clinical trial disclosure business process and ensure deliverables and delivery timelines in compli...

Role Description: The Scientific Communications MLR Technical Reviewer is responsible for checking all medical content for data and scientific accuracy, and reference appropriateness for materials submitted through the Medical, Legal, and Regulatory (MLR) process. This role ensures that all content adheres to Amgens scientific and compliance standards, while supporting timely review and approval of assets that inform and engage healthcare providers, patients, and internal stakeholders. Working closely with the US Scientific Communications MLR Reviewer, the Technical Reviewer brings scientific expertise, attention to detail, and compliance awareness to evaluate the submissions. This role cont...

Role Overview: Tradeweb is looking for a trade surveillance officer, based in Bengaluru, to provide trade surveillance coverage across Tradewebs European trading venues. The European trade surveillance team monitors and analyses the trading activity of all participants across the Tradeweb European platform. Surveillance utilises and develops electronic tools and integrative techniques to detect potential and/or actual violations of regulatory requirements, and works in close partnership with the wider Compliance team, Technology, Business Managers and various groups across the firm to ensure that Tradewebs markets remain clean and orderly. To succeed in this role, you will need to be a team-...

We are looking for a highly experienced and skilled finance professional to lead our financial team as a Director-Finance at Marriott International. The ideal candidate will have a strong background in finance and accounting, with excellent leadership and management skills. Roles and Responsibility Oversee the development and implementation of financial strategies to drive business growth. Manage and analyze financial data to inform business decisions and optimize performance. Lead and manage a team of finance professionals, providing guidance and support. Develop and maintain relationships with external stakeholders, including auditors and bankers. Ensure compliance with financial regulatio...

Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications....

Roles and Responsibilities Develop new APIs through organic synthesis, method development, and optimization. Conduct literature reviews to stay updated on latest research trends and technologies. Ensure compliance with GMP guidelines during API manufacturing processes. Collaborate with cross-functional teams for product development, scale-up, and commercialization. Perform impurity analysis using techniques like NMR, DSC, etc. Desired Candidate Profile MS/M.Sc(Science) degree in Chemistry or Ph.D/Doctorate in Chemical Sciences from a recognized university. Strong expertise in areas such as API synthesis, organic chemistry, method development/validation/transfer/methodology. 9-14 years of exp...

We are looking for a skilled HSE Officer to join our team in the international sector. The ideal candidate will have 3-7 years of experience in the field. Roles and Responsibility Develop and implement effective health, safety, and environmental management systems. Conduct regular audits and inspections to ensure compliance with regulatory requirements. Provide training and guidance on health, safety, and environmental procedures. Investigate incidents and accidents to identify root causes and implement preventive measures. Collaborate with other departments to develop and implement emergency response plans. Maintain accurate records of health, safety, and environmental performance metrics. ...