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...Job title: CMC Regulatory Technical Writer II
Location: Bridgewater, NJ, Hybrid
Duration: 1 year
SHIFT SCHEDULE 1st shift... ....g., briefing documents for meetings).
He/she defines and manages the compilation of the documentation, required for the authoring...
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...true to the best of my knowledge.
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Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC in Cambridge, MA with the following requirements: Masters degree in Regulatory Affairs or related field plus 2 years...
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...Description:**
BeiGene is seeking an experienced and energetic regulatory professional to manage, evaluate, and complete regulatory projects consistent... ...of strategies, planning, drafting, and managing CMC-related regulatory submissions and HA interactions to meet...
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CMC Regulatory Affairs Manager (Remote)
Contract: Thousand Oaks, California, US
Salary: $55.00 Per Hour
Job Code: 347260
End Date: 2024-05-19
Days Left: 25 days, 3 hours left
Apply...
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Reference Number: JO-2402-529329
Regulatory Specialist (CMC)
Rate: Negotiable
Job Type: Permanent
Location: Pomona
With a robust set... ...regarding CMC, dossier remediation, and product lifecycle management.
Animal health and GMP experience ideally
401k...
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...Reporting to the Vice President, CMC Regulatory, CARGO is seeking an Associate Director, CMC Regulatory to help progress development of... ...projects in a fast-paced environment utilizing excellent time management skills
* Adept at working autonomously, as well as collaboratively...
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...to the world's oldest enemy: disease.
As the Director, Regulatory Affairs CMC you will be responsible for developing and implementing regulatory... ...of responses to regulatory agencies.
Support change management: Represent regulatory CMC on and/or lead matrix teams on...
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...Description
We're looking for an Associate Director Regulatory Affairs CMC , working in Pharmaceuticals and Medical Products industry... ...clinical development, registration, and product life cycle management
Manages timely regulatory submissions that involve CMC...
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...part of our team:
POSTION SUMMARY
Associate Director, CMC Regulatory Affairs is a hands-on and independent role requiring a strong... ...in process controls, stability protocols, and change control management, and product and compliance quality initiatives.
* Support...
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...therapies to patients worldwide.
Join Takeda as a Director, Regulatory Affairs Vaccines CMC where you will provide program leadership and develop... ...you will contribute:
Lead planning, execution, and management of regulatory submissions for assigned vaccines in...
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Worldwide
...medicines to those who need them, improve the understanding and management of disease, and give back to our communities through... ...people around the world.
Organization Overview
The Global CMC Regulatory Associate, Global Regulatory Affairs (GRA) Regulatory Delivery...
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...Description Job Summary:
Seeking an experienced Regulatory Affairs professional with a strong background... ...experience of direct reports; matrix management experience preferred
~ In-depth knowledge of global CMC regulatory requirements, guidelines, and industry...
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...This role will lead and support the CMC strategies and submission including clinical... ...agency briefing packages and response to regulatory authority queries. The Director will... ...ensure that project team colleagues and management are informed of developments opportunities...
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...consultant will be treated with respect and professionalism.
CMC Senior Manager
Job Description
Location: New Brunswick, New Jersey... ...in the pharmaceutical industry, preferably with 3 years CMC regulatory experience.
Experience with CMC regulatory...
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...as a key strategic partner representing Global Regulatory activities? If so, this Director of Regulatory Affairs, CMC could be an exciting opportunity to explore. This... ...business initiatives.
* May have direct line management responsibility or act as individual contributor...
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...and inter-institution leader with a proven record of managing chemistry, manufacturing and control (CMC) projects to join our growing CMC group at ORIC... ...documentation, timelines, budgets, invoices, and assisting with regulatory filings.
Essential Functions
Support the...
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...The CMC Project Manager is a hybrid role combining PM and Finance responsibilities reporting both to line management and to Finance. The CMC Project Manager is responsible for supporting CMC functional roles in the areas of strategic and operational project and resource...
...Job Description
Job Description Job Title: Sr. Manager, Regulatory CMC
Location: Menlo Park, CA
Our Mission:
To build a viable long-lasting health care organization that assumes full responsibility for designing, developing, trial enrollment, regulatory...
Flexible hours
...partner with functional sub-team leaders to lead project management activities for a cell therapy program sub-team, guiding... ...any functional sub team depending on need, including CMC, Clinical, Research or Regulatory. The role may also help build overall project management...
...build your career.
Find your place at Pace
Join us as a CMC Regulatory Affairs Specialist, where youll put your love of science to... ...requirements
Communicate with the assigned FDA project manager regarding submissions, questions, and/or issues with application...
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Local area
2 days per week
3 days per week