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...The CMC Regulatory Lead will oversee the CMC regulatory activities for innovation projects and CMC maintenance within the CHC portfolio, as per assignment.
Main Responsibilities:
Represent GRA CMC CHC in Global cross-funtional teams and meetings, partners with the...
...Job Description
Job Description
Assistant Manager, CMC
Assistant Manager, CMC – Regulatory Affairs will be a part of the... ...GRACS team which supports regional CMC strategy, preparation of CMC documentation. Under the direction of the area supervisor, responsible for the...
...structural physiochemical parameters to achieve Product development with adherence to timelines.
Carry out Support Trouble shooting in CMC related activities and adequate investigation, identification, and rectification of problem to achieve Product development in...
...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...
...Author high quality global CMC documentation for Health Authority submission throughout
the product lifecycle, applying agreed CMC global regulatory strategies, current regulatory
trends and guidelines.
Ensure technical congruency and regulatory compliance, meeting...
The Regulatory CMC consultant will have experience:
Registration through NP, MRP, DCP and CP.
Post approval Submissions
Renewals and line extensions for EU, PAS, CBE applications for US and International.
Variations/notifications for ROW markets.
Assessment of Change Controls...
Work closely with Cloud product owners to understand, analyze product requirements and provide feedback.
Organized and goal-focused, ability to deliver in a fast-paced environment.
Architecture design and review of Cloud data pipeline, including data ingestion, extraction...
...Associate Manager, Regulatory Affairs (CMC)
at ClinChoice (View all jobs)
Bangalore or Hyderabad - India
ClinChoice is a global... ....
Technical review of all quality and administrative documents in line with current quality guidelines.
Prepare gap assessment...
...the regulatory submissions with minimal guidance.
Responsible for the preparation and finalization of Global Regulatory Strategy Documents(GRSD), CTD sections of supplements / variations for LCM submissions and ensures effectivedata presentation and quality.
Also provides...
Analytical method development and pre-validation involved in assigned projects
Analytical support for formulation development, optimization & scale-up, as applicable
Support Analytical method validation and method transfer involved in assigned projects
Preparation ...
...structural physiochemical parameters to achieve Product development with adherence to timelines.
Carry out Support Trouble shooting in CMC related activities and adequate investigation, identification and rectification of problem to achieve Product development in compliance...
...WE ARE LOOKING FOR CANDIDATES WITH 3-5 YEARS- INTO IMPORT DOCUMENTATION, WHO WORK WITH FREIGHT FORWARDING, NOT SHIPPING AND IS RESIDING IN WESTERN LINE(MUMBAI) ANY IRRELEVANT APPLICATIONS WILL BE REJECTED.
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Position: Import Documentation...
...We are looking for a Document Controller to prepare, manage and file documents for our projects.
Document Controller responsibilities include typing contracts, archiving files and ensuring all team members have access to necessary documentation. To be successful in this...
...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...
...JOB DESCRIPTION
Job Summary
If you are an Engineer / Document Controller professional looking for an opportunity to grow, Emerson has an exciting opportunity for you! Be a member of Centre of Excellence (CoE) Customer Care team to support the Project Management team by...
...Are you passionate about documentation
Do you have a keen eye for detail
Baker Hughes is seeking a Document Controller
At Panametrics, a Baker Hughes business, we provide intelligent, connected hardware technologies to sense, control, and inspect assets across many...
...and policies framed by Global Regulatory Affairs.
Responsible for the preparation and finalization of Global Regulatory Strategy Documents (GRSD), Comparative Toxicogenomics Database (CTD) sections of supplements / variations for Lifecycle Management (LCM) submissions and...
...Job Description
Job Title: Document Controller
Location: Chennai, India
Join Us!
We combine AtkinsRealis project management expertise and Hitachi Energy's deep technological knowledge to create a company dedicated to substations ' we are Linxon!
The Document...
...office and reports to the Senior Director, Rights Management
About the role:
The Rights Management Team at TMB is looking for a Document Coordinator. This position will be primarily responsible for obtaining appearance releases by working across departments to collect...
...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,...