- Blonde Inc. (Boston, MA)
- Hemab is seeking a Director of Regulatory Affairs , CMC to lead global regulatory strategy across our portfolio of rare disease therapies. This role ... briefing documents, responses to agency questions, and participation in regulatory meetings (Type B, Type C, Scientific ... regulatory inspections readiness. Mentor and develop junior regulatory staff in CMC regulatory affairs… more
- BioNTech IMFS (Cambridge, MA)
- Associate Director , Global Regulatory Affairs Cambridge, US; New Jersey, US | full time | Job ID:9842 Company Summary BioNTech is a Nasdaq listed ... (COVID-19 vaccine) is its first commercialized product. Position Summary The Associate Director , Regulatory Affairs (Advertising and Promotion) will have… more
- Madrigalpharma (Waltham, MA)
- Associate Director , Regulatory Affairs , Advertising and Promotion page is loaded **Associate Director , Regulatory Affairs , Advertising and ... a Phase 3 trial for the treatment of NASH with compensated cirrhosis.The Associate Director , Regulatory Affairs , Advertising and Promotion is responsible for… more
- Crescent Biopharma, Inc. (Waltham, MA)
- …www.crescentbiopharma.com and follow the Company on LinkedIn and X. Position Overview Our Director , Regulatory Affairs , will support the development and ... years of relevant pharmaceutical/biotechnology industry experience including experience in Regulatory Affairs related development of pharmaceuticals; phase 1… more
- Takeda (Boston, MA)
- …area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively ... area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively… more
- TechDigital Group (Danvers, MA)
- Overview The Medical and Scientific Affairs function provides leadership and direction on medical, scientific and clinical decisions related to the overall ... Leica Biosystems business strategy. The Medical Affairs Operations manager is responsible for the implementation, execution, and status tracking of a variety of… more
- Takeda (Boston, MA)
- …Analytical Development, Production, Quality Assurance can be considered. Understanding of scientific principles and regulatory CMC requirements relevant to ... as follows: Independently develops and leads the execution of regulatory CMC investigational, registration and/or post‑approval strategies for assigned products… more
- Madrigalpharma (Waltham, MA)
- …the creation and execution of Scientific Content and Training within Madrigal Medical Affairs . The Director will contribute to the Medical Affairs and ... Director , Content and Training, Medical Affairs ...scientific content and training materials. Ensure compliance with regulatory standards, Madrigal policies, ethical guidelines, and proper utilization… more
- Vertex Pharmaceuticals (Boston, MA)
- …requisition id: REQ-27477**Job Description General Summary:**The Medical Affairs Senior Director provides medical and scientific leadership in the assigned ... Senior Director , Global Medical Affairs - Nephrology...work closely with a cross-functional group to ensure that scientific and medical strategies are aligned with broader corporate… more
- Pharmaessentia Corporation (Boston, MA)
- …the MSL director Provide cross-functional support to MSLs, medical information, regulatory affairs and clinical development with medical and scientific ... biologics production facility in Taichung. Position Overview The Senior Director , Medical Affairs role will identify and...and approve medical and scientific content of Regulatory , Safety, Medical Affairs , and Commercial Partner… more
