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Takeda Development Center Americas, Inc. is seeking a Manager, Regulatory Affairs
CMC in Cambridge, MA to Develop the Global Regulatory Strategy for products in commercial and development phase; ensure timely submission of new submissions (IND, NDA, BLA, JNDA) to various...
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...Job title: CMC Regulatory Technical Writer II
Location: Bridgewater, NJ, Hybrid
Duration: 1 year
SHIFT SCHEDULE 1st shift... ...functions such as quality, manufacturing, Global Regulatory Affairs (GRA), technical experts from global locations or contract manufacturing...
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...Who You Are
The Associate Director, Regulatory Affairs (CMC) works closely with the manufacturing department and individual program teams to ensure CMC compliance and promote overall regulatory success. The Associate Director, Regulatory Affairs (CMC) possesses strong...
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...The Associate Director of Regulatory Affairs CMC will support development CMC team activities for an emerging portfolio of biologics products. This position will oversee CMC Health Authority submissions, collaborating across the business and with external partners to...
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...quickly have you in front of a live recruiter.
The Opportunity
Description
We're looking for an Associate Director Regulatory Affairs CMC , working in Pharmaceuticals and Medical Products industry in Cambridge, Massachusetts, United States .
Leads...
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...seriously. Learn more about our work, our culture, and what it's like to be a part of our team:
POSTION SUMMARY
Associate Director, CMC Regulatory Affairs is a hands-on and independent role requiring a strong individual who will provide strategic and operational...
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The Associate Director of Regulatory Affairs CMC will be responsible for developing, implementing and advising on global Regulatory CMC strategies for new and late stage programs to secure approval of the manufacturing process and control testing for initial clinical trials...
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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... ....
* Identifies key risks to the business associated with submission data and information packages and...
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Flexible hours
...therapies to help people build families, stay healthy, and stand up to the world's oldest enemy: disease.
As the Director, Regulatory Affairs CMC you will be responsible for developing and implementing regulatory strategies for US CMC activities throughout the product...
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...Contract Duration: 6-18 months
Rate: Negotiable
Responsibilities:
Excellent employment opportunity for a Regulatory Affairs CMC Associate in the Foster City, CA area. Bay area candidates ONLY
Provide Regulatory CMC support for biologic and small molecule...
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...Responsibilities:
We are inviting applications for the role of CMC 2 Regulatory affairs. Responsibilities:
Well versed in performing CMC compliance activities including Gap Analysis and assessment for Annex 3 comparative table with reference EU Member States...
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CMC Regulatory Affairs Manager (Remote)
Contract: Thousand Oaks, California, US... ...experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma /...
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...boundaries of what is possible in order to bring life-changing therapies to patients worldwide.
Join Takeda as a Director, Regulatory Affairs Vaccines CMC where you will provide program leadership and develop CMC regulatory strategy for global vaccine programs in various...
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...lives of patients we serve.
About the Role
The Regulatory Associate will be part of the Regulatory Affairs team reporting to the Director of Regulatory... ...technical, medical/clinical team with post marketing CMC changes, labeling and packaging review, and phase IV...
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...facilities anchored around deep expertise in immunology and complemented by an expanding set of capabilities.
Associate Director, Global Regulatory Affairs, CMC Authoring (Remote)
You will author global quality regulatory documents and provide input into development...
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Worldwide
...Job Summary:
Seeking an experienced Regulatory Affairs professional with a strong background in... ...~ In-depth knowledge of global CMC regulatory requirements, guidelines, and... ...Benefit offerings available for our associates include medical, dental, vision, life insurance...
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...rewarding work experience that lets you be at your best and have an impact on our patient communities.
Overview:
The Regulatory Affairs Associate is a key contributor to the regulatory affairs team at Ajinomoto Cambrooke, Inc. This position is responsible for...
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...company growth is not stopping any time soon, and we are looking for great talent to join our team!
We are looking for a Regulatory Affairs Associate to join the regulatory team, which works across all lines of our business. As a Regulatory Affairs Associate, you will...
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...to feed the world while protecting our planet's natural resources, we'd love to hear from you!
About the role....
As the Regulatory Specialist, you will be responsible for support in the tracking and execution of the overall regulatory plan to obtain needed authorizations...
Work experience placement
Local area
...timelines.
Responsible for maintaining and updating various regulatory databases to ensure accuracy of information.
Archive and maintain... ...’s Degree in a scientific area (Degree in Pharmacy/Regulatory Affairs is preferred)
2-3 years’ experience in the pharmaceutical...
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