Average salary: $174,876 /yearly
More statsSearch Results: 48 vacancies
$78.12 - $130.21 per hour
...the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.
Join Takeda as a Director, GRA CMC Pharmaceuticals, Oligonucleotides where you will lead the GRA CMC Pharmaceuticals regulatory team in the development and...
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$133.2k - $223.2k
...of my knowledge.
Job Description
Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC in Cambridge, MA with the following requirements: Master’s degree in Regulatory Affairs or related field plus 2 years of related experience...
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$138.5k - $186k
...of my knowledge.
Job Description
Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC Submissions Management in Lexington, MA with the following requirements: Bachelor’s degree in a scientific field or foreign academic...
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$88.54 - $130.21 per hour
...colleagues in quality and commercial organizations to manage pipeline products and bring current products to industry standards.
Represent CMC and GRA on key governance committees and play a critical role in driving the organization towards innovative approaches for the...
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...Job Description
Job Description Objective
The Director, CMC Operations responsible for technically designing, managing, and executing a plan for the use of alpha emitting Pb-203 & Pb-212 radiopharmaceuticals and the manufacturing of drug candidates supporting...
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...Description
Job Description Our Pharmaceutical client is seeking a Director Regulatory Affairs Chemistry Manufacturing & Controls (CMC) to guide global teams through the development and execution of regulatory strategy and the design of CMC components of drug...
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...Clients s US Regulatory electronic document management system.
ORGANIZATION STRUCTURE
The Senior Associate, Regulatory Operations/CMC reports into the Manager/ Director, Regulatory Affairs and is based in Morristown, New Jersey.
RESPONSIBILITIES
Primary...
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...Program Leader will lead a cross-functional team across clinical operations, regulatory affairs, clinical pharmacology, biomarkers, CMC, non-clinical, and medical to deliver against the program strategy. The successful candidate will have experience in development of Oncology...
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$78.12 - $130.21 per hour
...worldwide.
Join Takeda as a Senior Director, GRA Pharmaceuticals- Small Molecule where you will establish collaboration with Global CMC teams and leadership through networks and enable CMC regulatory team’s success in meeting goals/objectives. You will also influence...
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...Responsibilities
Independently design, conduct, lead and supervise characterization studies for pMDIs and DPI products.
Provide leadership in CMC activities and represent CMC on global project teams.
Act as subject matter expert (SME) on aerosol analytical characterization...
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...available to respond to questions throughout the day, to ensure production goals are achieved and work performed is in compliance with CMC, client and utility program procedures and guidelines. This individual will direct and coordinate field programs to ensure maximum...
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...+ Familiarity with EMA and FDA regulatory requirements for process development submissions
+ Broad knowledge of drug development, CMC, MST, preclinical and clinical requirements
+ Experience in effectively managing scientific groups and projects
+ Demonstrated effective...
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...overall project plans.
Partners with and provides subject matter expertise to key internal functions (regulatory, Quality, Clinical, CMC and formulations, Product Quality, Drug safety, Medical affairs) and their external contractors or collaborators.
Contributes to...
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...Operations
Strategy
Known Requirements
Bachelor’s degree in a scientific discipline required
Strong oncology experience required
In-depth knowledge of relevant regulatory guidelines and requirements required
Regulatory CMC and CDx expertise required...
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...and antibody protein drug to accelerate drug development for customers. GenScript ProBio's total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing. In terms of plasmid service,...
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...and antibody protein drug to accelerate drug development for customers. GenScript ProBio's total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing. In terms of plasmid service,...
...organization including significant experience in a Regulatory Affairs leadership role
Oncology experience required
Regulatory CMC and CDx experience is preferred
In-depth knowledge of relevant regulatory guidelines and requirements, with a focus on the US and...
2 days per week
...s drug development programs, policies and procedures; ensuring a compliant state of regulatory commitment. Ensures that appropriate CMC regulatory activities occur in support of both pre and post-approval submissions while meeting aggressive timelines and adhering to the...
...commercialization.
~ Working knowledge of all functional areas of exploratory development, including chemistry/biochemistry, biology, toxicology, CMC, translational medicine, early clinical development, regulatory, etc., and demonstrated ability to successfully and effectively...
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...organization, including significant time in a regulatory affairs leadership role. Oncology experience is required, and experience in regulatory CMC and CDx is preferred. The role demands in-depth knowledge of US and EU regulatory guidelines, a proven track record of gaining...
