team in conjunction with global regulatory lead(s). Prepare, coordinate and/or review all CMC and GMP related documents...Provide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small...
otherwise intractable classes of proteins as drug targets. Position Senior Director, Global Regulatory Affairs - Chemistry... Manufacturing Controls (CMC) will be responsible for the design, preparation and execution of global regulatory strategies...
on , , , , and . Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external..., and Research & Development (R&D) organizations. Represents CMC on teams such as product development, Global Regulatory Product...
Responsibilities: The Regulatory Affairs CMC Senior Manager at is responsible for providing strategic direction... exercises. Collaborates with colleagues across the global RA CMC organization, Gilead regulatory affairs, and affiliates...
. Join Gilead and help create possible, together. Job Description Responsibilities The Regulatory Affairs CMC Senior Manager... CMC organization, Gilead regulatory affairs, and affiliates on internal meetings and Health Authority interactions...
Position: Senior Manager/Associate Director, Regulatory Affairs CMC (EDG-2025025) Location: Boston, MA Job Id: 185... # of Openings: 1 Senior Manager/Associate Director, Regulatory Affairs CMC About Edgewise Therapeutics: At Edgewise...
may be considered. Industry experience of 8 years, of which at least 5 years spent in regulatory affairs with CMC...Responsibilities: Actively participate on CMC development teams to plan regulatory strategies by defining pathways...
may be considered. Industry experience of 8 years, of which at least 5 years spent in regulatory affairs with CMC...Responsibilities: Actively participate on CMC development teams to plan regulatory strategies by defining pathways...
regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory operations, etc.) to develop global...Position Summary Provides critical support in developing global regulatory strategy, planning and execution of global...
execution of multi-product global regulatory CMC strategies for investigational and marketed products. This role leads the... of regulatory submissions, as well as the interactions and responses with regulatory agencies Develops global regulatory CMC...
must be PST - West Coast California As a Senior Manager in the Regulatory CMC department this individual will be responsible.../accountable for: RESPONSIBILITIES Planning, preparation and submission of global regulatory CMC-related content pertaining...
advances to patients who live with genetic diseases. As a Senior Manager in the Regulatory CMC department this individual... Teams) and Regulatory CMC (Global REG CMC Product Lead) to prepare, review, and approve international regulatory submission...
advances to patients who live with genetic diseases. As a Senior Manager in the Regulatory CMC department this individual... will be responsible/accountable for: RESPONSIBILITIES Planning, preparation and submission of global regulatory CMC-related content...
, when required. Provide guidance and advise management regarding improvement in CMC harmonization process of regulatory... and approved applications. Lead, guide, and train the CMC team to ensure highly qualified personnel that can perform to meet...
Senior Specialist Regulatory Affairs executes on the pharmaceutical regulatory strategies for assigned brand products... filing Work with the Pharmaceutical Regulatory Brand Senior Manager to make certain all product documentation is developed...
of this position to act as a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions... as required. Additional Responsibilities, Knowledge, Skills and Abilities: Global Regulatory CMC Experience is preferred. Ability to work...
of this position to act as a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions... as required. Additional Responsibilities, Knowledge, Skills and Abilities: Global Regulatory CMC Experience is preferred. Ability to work...
. Fosters effective and productive communication among various Regulatory Affairs groups including Regional Regulatory Leads..., Regulatory CMC, Labeling, Advertising and Promotion, Regulatory Operations, Medical Writing, and representatives...
Description Job Title: CMC Product Development Senior Manager Reports To: Vice President of CMC Product... is built on: Transformation, Execution and Trust. Job Purpose: The CMC Product Development Senior Manager oversees...
The Sr. Manager, CTA Regulatory Strategy is responsible for providing critical support in developing global regulatory... budgets Work collaboratively with members of the global regulatory team (GRL, Clinical Transparency, Medical Writing, GRA-CMC...