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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...
...Regulatory Affairs Specialist - CMC Variations/Submissions
12 month contract - Immediate start
Overview: Join our Regulatory... ...Submission Dispatch: Ensure timely dispatch of all regulatory documents to appropriate bodies.
Health Authority Correspondence: Manage...
...categories we play in: Allergy, Digestive Wellness, Pain, Physical & Mental Wellness, and Cough, Cold & Flu.
JOB PURPOSE
The Regulatory CMC Lead will oversee the CMC regulatory activities for maintenance and sustainability projects within the CHC portfolio, as per assignment...
...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...
...Position Description:
The purpose of Associate Manager, Global CMC Regulatory, is to work cross functionally with Elanco... ...applying the global strategy into submissions.
Ensure the required documentation and any content, quality and/or timelines for global submissions...
...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
Job Title: International CMC RA Associate Director.
Career Level - E
Introduction to Role:
Join us at AstraZeneca... ...CMC submissions and review and approve regulatory CMC documents for assigned projects.
Essential Skills/Experience:
- Degree...
...and policies framed by Global Regulatory Affairs.
Responsible for the preparation and finalization of Global Regulatory Strategy Documents (GRSD), Common Technical Document (CTD) sections of supplements / variations for Lifecycle Management (LCM) submissions and ensure effective...
...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...
...Job Description
Job Title: International CMC RA Manager I
Career Level - D
Introduction to Role:
Join us at AstraZeneca... ..., and production of Chemistry, Manufacturing and Control (CMC) documentation for designated product ranges. You will project manage global CMC...
...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...
...Primarily Responsible for managing assigned regulatory projects/ CMC programs of moderate complexities, managing and ensuring daily delivery... ...including the related technical/supportive information/ documents for completeness and accuracy; Responsible for development of initial...
...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...
...Job Description
Job Summary
The Document Controller (DC) is a vital member of the project support team, who is in-charge of document management. The DC is involved from the conception of the project till the end of the project. During the project life cycle, the DC...
...Brands-LEC team, working with Global Regulatory Strategist (GRS-CMC) and Cross Functional Teams to prepare and submit the variations... ...change controls for completeness, accuracy and required supporting documents. Initiate change controls when needed.
Performs Market Impact...
...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,...
...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,...
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...