dossier

Contracttype Zelfstandig of Loondienst Locatie Hybride Contact wrasschaert@rasschaertadvocaten.be Solliciteer nu Over ons Rasschaert advocaten werkt voor de publieke sector, lokale besturen, zorg- en onderwijsinstellingen, culturele organisaties en andere non-profit organisaties in Vlaanderen en Brussel. We begeleiden meer dan 150 lokale besturen,...

Key Responsibilities Prepare, review, and submit product registration and renewal dossiers (CTD/ACTD) for Europe and Southeast Asia markets Understand, interpret, and implement regulatory guidelines applicable to different European Union and Southeast Asia countries Prepare and renew registrations, manufacturing licenses, product approvals, WHO-GMP...

Contracttype Stage Locatie ’T Landhuys van Leeuwergem Contact wrasschaert@rasschaertadvocaten.be Solliciteer nu Over ons Rasschaert advocaten werkt voor de publieke sector, lokale besturen, zorg- en onderwijsinstellingen, culturele organisaties en andere non-profit organisaties in Vlaanderen en Brussel. We begeleiden meer dan 150 lokale besturen,...

• Responsible for All type of Mechanical (Tensile, Impact, Drop-weight, Hardness) & Chemical Testing (PMI, Spectro Analysis, Carbon & Sulphur Analysis) of material and Weld. • Responsible for compilation of Final documents dossier • Responsible for Calibration of Measuring and testing instrument • Data compilation and analysis related to testing and...

Experience: 3 to 8 years Designation: Executive / Officer Department: Regulatory Affairs - ROW Markets Qualification: M.Pharm Job Location: Ahmedabad Job Details mentioned below: • Preparation and compilation of dossiers for ROW, LATEM, CIS (Kazakhstan, Ukraine, Uzbekistan), Africa (South Africa, Tanzania, Kenya, Uganda, Zazibona) & French West Africa...

Key Responsibilities Prepare, review, and submit product registration and renewal dossiers (CTD/ACTD) for ROW markets Understand, interpret, and implement regulatory guidelines applicable to different ROW countries Prepare and renew registrations, manufacturing licenses, product permissions, WHO-GMP certificates, MSO registrations, and other required...

Key Responsibilities Prepare, review, and submit product registration and renewal dossiers (CTD/ACTD) for ROW markets Understand, interpret, and implement regulatory guidelines applicable to different ROW countries Prepare and renew registrations, manufacturing licenses, product permissions, WHO-GMP certificates, MSO registrations, and other required...

-Responsible for All type of Mechanical (Tensile, Impact, Drop-weight, Hardness) & Chemical Testing (PMI, Spectro Analysis, Carbon & Sulphur Analysis) of material and Weld.-Responsible for compilation of Final documents dossier- Responsible for Calibration of Measuring and testing instrument- Data compilation and analysis related to testing and Final...

Preparation & compilation of Dossiers Knowledge of UK & EU Market, CTD Review of Artwork. Registration of renewal of products Solve Queries & Timely compile materials for license renewals, updates and registration Review changes to existing products Education PG:  M.Pharma in Pharmacy

• Manage global regulatory product documentation, including technical files, registration dossiers, IFUs, and labeling • Ensure compliance with regulatory standards and testing requirements throughout product design and development • Coordinate regulatory approvals and change notifications with Notified Bodies and Authorities • Ensure global...

Key Responsibilities: Regulatory Expertise: Manage the regulatory process for Pharmaceutical Finished Formulations across CIS, LATAM, and Africa.Dossier Management: Compile and review ACTD and CTD dossiers to ensure accuracy and compliance.MOH Query Response: Address and respond to any Ministry of Health (MOH) queries for dossiers submitted in the...

Job description Role & responsibilities Feasibility assessment/ new product evaluation Literature review and BA/BE study designing BE Study Monitoring Preparation of documents for regulatory submission (i.e BENOC, Import license application etc.) Establishment and maintenance of study documents Document preparation for dossier submission (i.e clinical...

Job description Role & responsibilities . Feasibility assessment/ new product evaluation • Literature review and BA/BE study designing • BE Study Monitoring • Preparation of documents for regulatory submission (i.e BENOC, Import license application etc.) • Establishment and maintenance of study documents • Document preparation for dossier...

Role & responsibilities  : Review of CMC documents as per submission checklist Aware of regulatory requirements and guidances for dossier submission Review of all plant related change control and provide assessment Support plant team for all regulatory audit Maintain status of all submissions and approvals required for site QMS Communicate with all Cross...

Description You’re driven, resourceful, and above all else - remarkably smart. In this role, you will support the HEOR team in evidence generation and deriving solutions for clients in the healthcare and life sciences sectors. You will contribute to conducting literature reviews and assist in the development of value communications such as SLR/TLR...

Ensure the on-time filing of high-quality regulatory submissions, and to assist in the preparation, maintenance, and control of regulatory Dossiers. Interact with all levels in the organization, and across several functions particularly Compliance, Marketing, R&D, engineering, manufacturing, and QA/QC. Participate in discussions to provide strategic...

Description You’re driven, resourceful, and above all else - remarkably smart. In this role, you will support the HEOR team in evidence generation and deriving solutions for clients in the healthcare and life sciences sectors. You will contribute to conducting literature reviews and assist in the development of value communications such as SLR/TLR...

Career CategoryHealth EconomicsJob DescriptionSenior Associate: Global HEOR Value Writing Department: Global Health Economics & Outcomes Research (HEOR)Job Family: Health EconomicsJob Type: Full-TimeLocation: Hyderabad, IndiaReports To: Global Value Writing Team LeadPosition SummaryThe Global HEOR Value Writing Senior Associate plays a critical role in...

Career CategoryHealth EconomicsJob DescriptionGlobal HEOR Value Writing ManagerDepartment: Global Health Economics & Outcomes Research (HEOR)Job Family: Health EconomicsJob Type: Full-TimeLocation: Hyderabad, IndiaReports To: Global Value Writing Team LeadPosition SummaryThe Global HEOR Value Writing Manager plays a critical role in supporting Amgen’s...

Experienced in ensuring all Hydro-Mechanical (HM) fabrication and erection activities comply with approved drawings, technical specifications, quality requirements, and QA/QC standards. Proficient in monitoring fit-up, alignment, welding activities, dimensional accuracy, and fabrication tolerances to ensure adherence to project requirements. Skilled in...