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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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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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...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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Local area
...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
...and 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...
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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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Exec Director Regulatory Affairs/CMC
Allakos Inc. is a dynamic clinical-stage biopharmaceutical company developing first-in-class antibody-based... ...tactical plans. Identify and assess regulatory risks associated with assigned projects.
Leads the development of strategic...
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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...
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...Description
Reporting to the Vice President, CMC Regulatory, CARGO is seeking an Associate Director, CMC Regulatory to help progress development of our cell-based gene therapy portfolio.
The successful candidate will have a strong background in regulatory CMC with...
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...Associate Director, Regulatory Affairs - (***) ***-****W
Description
Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of... ...regional teams, Chemistry, Manufacturing, and Controls (CMC), commercial strategies, and the Target Product Profile....
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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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Hourly pay
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Worldwide
...Schrdinger seeks an Associate Director of Regulatory Affairs to join our New York early clinical development team. This hire will report to the Director... ...Finally, having sufficient working knowledge of regulatory CMC within the EU to support globalization efforts....
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Home office
Flexible hours
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...burden of disease.
Description:
Reporting to the Sr. Director of Regulatory Affairs and Policy, this role will support and lead activities... ...the group and across drug development disciplines such as CMC, Nonclinical, Clinical and Quality. This position will be...
Local area
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...Mammoth BioSciences
OPPORTUNITY
Mammoth is hiring a Director/Sr. Director, Regulatory Affairs, Therapeutics, to lead the regulatory activities of our... ...regulatory knowledge of US and EU
Interface with CMC, nonclinical research and clinical research personnel and...
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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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...401K, and more
Brief Description
The Assistant Director, Economic and Regulatory Affairs is responsible for:
Identifying and analyzing private... ...consensus.
Prior health/medical society or association experience preferred.
Knowledge of pathology or laboratory...
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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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