- Takeda Pharmaceuticals (Boston, MA)
- …the global regulatory strategy is updated and executed, ensuring global regulatory compliance . + Ensures global regulatory strategies defined within ... to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. + Is a leader both in… more
- System One (Florham Park, NJ)
- …Qualifications + Minimum of 1-2 years of experience required within a pharmaceutical regulatory environment, including eCTD publishing of INDs and NDAs. ... in accordance with established timelines and submission dates in compliance with local and global regulatory requirements...dates in compliance with local and global regulatory requirements for the different application types (eg, IND,… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …submits regulatory documents, and maintains records on assigned studies to ensure regulatory compliance with DFCI and DF/HCC policies as well as federal ... with amazing partners, including other Harvard Medical School-affiliated hospitals. + ** Regulatory Compliance ** + Prepares and submits all protocol applications,… more
- Actalent (Maryland Heights, MO)
- …Director of Regulatory Affairs is tasked with overseeing Nuclear Medicine Regulatory Affairs dossiers and ensuring compliance with regulatory operations ... and existing dossiers, ensuring successful submissions. + Implement tracking systems for regulatory affairs compliance and operations. + Prepare and submit… more
- Cardinal Health (Oklahoma City, OK)
- …functions and teams and delegate and direct non-legal tasks to support regulatory compliance implementation. **_Qualifications_** * Bachelor and JD degrees ... from other functions and teams and delegate and direct non-legal tasks to support regulatory compliance implementation **_What is expected of you and others at… more
- Takeda Pharmaceuticals (Boston, MA)
- …the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible. + ... maintain compliance for products. + Oversee vendor responsibility for regulatory activities and submissions related to projects within scope. + Participates with… more
- Sanofi Group (Morristown, NJ)
- …record with a minimum of 1 year (3+ years preferred) of regulatory experience, preferably within the pharmaceutical /medical device/biotech industry + Knowledge ... **Job Title:** Associate Director, Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are you ready to… more
- Bristol Myers Squibb (Princeton, NJ)
- …Drug Promotion advisory submissions and sub part e submissions + Ensure full regulatory compliance of all promotions with approved labeling and /or FDA ... guidances + Ensure regulatory compliance with sub part e and... promotional review or related 5 to 8 years pharmaceutical experience (eg, Medical promotional review) + Experience providing… more
- Takeda Pharmaceuticals (Boston, MA)
- …life-changing therapies to patients worldwide. Join Takeda as Senior Manager, Global Regulatory Labeling Strategy where you will be responsible for the development ... CCDS, USPI and EU SmPC enabling the most up-to-date information and in compliance with labeling requirements to be provided to patients and Health Care Providers… more
- University of Pennsylvania (Philadelphia, PA)
- …requisite ancillary review committees. + Prepare and process all required regulatory documentation for pharmaceutical companies, contract research organizations ... study specific case report forms, as well as, to provide direct regulatory / compliance guidance. + Perform additional regulatory duties as assigned.… more