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...Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation and publication of REG CMC documentation for submissions to Health Authorities. In addition interact with HA's on REG CMC questions to...
...guidelines and quality requirements of DNV.
Maintain the confidentiality of clients' business, processes, designs, developments and documentation.
Communicate to line management at the earliest appropriate opportunity if in receipt of information that is important to the...
...join our team today!
The purpose of Associate Manager, Global CMC Regulatory, is to work cross functionally with Elanco manufacturing... ...the global strategy into submissions.
Ensure the required documentation and any content, quality and/or timelines for global submissions...
...that see themselves imagining the unimageable with us.
Your Role:
Accountability:
This Role will be fully dedicated on CMC regulatory intelligence team activities, aiming to enhance the GRA CMC knowledge sharing culture, with a specific focus on the following...
...submissions and ensure effective data presentation and quality through effective review.
Responsible for authoring quality and timely CMC contributions for license maintenance activities such as US Annual Reports, Renewals, APRR, YBPR, In-house submission (Brazil) and BPDR...
...Job Description: Position : Assistant Scientist / Scientist - CMC (Formulation)
Reporting to : Lead scientist/Associate Director -CMC
Location : Hyderabad, India
Education/Qualifications : M. Pharm/Ph.D from premier institute.
Experience : At least 7-9 years...
...working with cross functional team, site team and corporate regulatory team to ensure preparation of quality global regulatory strategy document and supplements / variations.
Responsible for the preparation and finalization of Global Regulatory Strategy Documents (GRSD), CTD...
...focus on tendering, engineering, planning, procurement, project Management, functional system testing, installation supervision, documentation and commissioning. However, over the last decade, it has evolved to become the largest Operations hub. The India Operations Centre...
...focus - Deliver on our promise
Integrity - Always do the right thing
Create opportunity - for our people to excel.
Provides document management and general administration support to the project team. Typically involves smaller projects where time is shared between...
...more: careers.bms.com/working-with-us.
Position Summary
The CMC Regulatory Associate Director, Small Molecule is responsible for... ...completeness and timeliness, including creation and maintenance of strategy documents.
Manage relationships with diverse teams.
Utilize...
...Chemistry with MBA or business exposure
Knowledge, Skills, and Abilities
Knowledge of Pharma R&D outsourcing market in General and CMC / CDMO Services is a must
A hands-on attitude with an excellent understanding of financial matters
A successful people leader...
...Opportunity with Global Product Base Company - Pune!
Key Skills:
·This is similar to content management & repository
·Lifecycle of Document which includes document ingest, archiving and consumption
·IBM Datacap , IBM Filenet , OpenText Vignette Image Capture,...
Job description:
-Reviewing documents & original licenses of all applicants &joiners to the vessels.
-Ensuring licenses &Travel Documents are valid.
-Vessel/Ship operations. -Must have knowledge of shipping industry.
Location - Govandi /Chembur
Required Candidate...
...energy solutions and contributing to a cleaner and greener future.
Role Description
This is a full-time on-site role for a Documentation Executive located in Thodupuzha. As a Documentation Executive, your responsibilities will include handling export documentation,...
...Client focus -Deliver on our promise
Integrity - Always do the right thing
Create opportunity - for our people to excel.
The document controller provides accurate and timely administration and information management by coordinating and organising the numbering,...
...Factor I: Accountability • • Handle multiple project documents, preparing transmittals, receiving vendor / customer documentation and distributing internally on time •
• Track documents on a project using a documentation system and generate reports on overdue documents and...
Tacnique is looking for Documentation Writer to join our dynamic team and embark on a rewarding career journey
# Collaborate with subject matter experts, software developers, product managers, and other stakeholders to gather information and understand the features, functionalities...
...clients to succeed at the highest level.
About the Job:
Responsible for handling, organizing, and distributing, all project documents, including but not limited to drawings, contracts, specifications, and other correspondence related to the project. Ensures that all...
...technology developed by Hitachi Energy that offers additional benefits compared to HVDC Classic.
Mission Statement:
Project Document distribution to the internal team and externally to customers. Responsible to keep track of document status and provide inputs to project...
One of our prestigious clients in Kingdom of Saudi Arabiais looking to hire a Document Controller , who will be responsible for but not limited to:
Key Accountabilities:
Ensure the smooth functioning of the department's documentation processes.
Develop and manage...
