- Sumitomo Pharma (Boston, MA)
- …clinical regulatory strategies including management of IND and NDA submissions, FDA and other global regulatory interactions, as well as international ... proposed claims and assess consistency of proposed claims with FDA -approved labeling + Provide regulatory leadership to...experience in preparing strategies for and submitting applications for drug or biologic products (INDs, NDAs, MAAs) + NDA… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …products and drug -device combination products. Ensure compliance with global regulations ( FDA , EMA, ICH, WHO) and anticipate regulatory changes impacting CMC ... **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global … more
- Takeda Pharmaceuticals (Boston, MA)
- …related experience. + Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA , EU, Canada, ROW and post-marketing a ... on patients worldwide. Join Takeda as Associate Director, Global Regulatory Lead Oncology where you will be part of...lead as a member of a GRT + Primary FDA contact for projects of responsibility. + Accountable for… more
- Takeda Pharmaceuticals (Boston, MA)
- …Late-Stage assets. + Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA , EU, Canada, ROW and post-marketing a ... oncology portfolio with potentially first-in-class and best-in-class therapies, including antibody- drug conjugates (ADCs), complex biologics and small molecules. Our… more
- Dana-Farber Cancer Institute (Boston, MA)
- …reports, to the appropriate regulatory agencies including the Food and Drug Administration ( FDA ), Office of Biotechnology Activities (OBA), etc. + Prepares, ... documents for SRC and IRB review and approval + Prepares and submits regulatory documentation that may include IND/IDE applications, FDA annual reports, Serious… more
- Dana-Farber Cancer Institute (Boston, MA)
- …applications to the appropriate regulatory agencies including the Food and Drug Administration ( FDA ), Office of Biotechnology Activities (OBA) + Support the ... all required deviation, violation, exception, or other event reporting. Ensure various regulatory reporting requirements are met, Study Sponsor, FDA , IRB, etc.… more
- Takeda Pharmaceuticals (Boston, MA)
- …regulatory submissions. + Expert knowledge of drug development process and regulatory requirements. Knowledge of FDA , EU, Canada, ROW and post-marketing a ... + Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple… more
- Takeda Pharmaceuticals (Boston, MA)
- …related experience. + Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA is a must. Knowledge of EU, Canada, ... on patients worldwide. Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of...lead as a member of a GRT + Primary FDA contact for projects of responsibility. + Accountable for… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- … strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment ... of the drug development process, laws, regulations, and guidelines including FDA , ICH, etc. - Able to successfully interpret and apply regulatory … more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …of regulatory affairs experience. + Minimum 2-3 years' work experience in regulatory intelligence. + Previous interactions with FDA or other health authority ... The Associate Director of Regulatory Intelligence leads the collection and dissemination of...JPMA, etc.). + Demonstrate solid working knowledge of the drug , biologic, and device development process, laws, regulations, and… more