- State Street (Boston, MA)
- … Relations who reports to the Chief Compliance Officer. The Head of Regulatory Interactions is responsible for managing the global regulatory ... Kansas City, Missouri; Jacksonville, Florida Who we are looking for: The Head of Regulatory Interactions is a senior leadership position within State… more
- Ironwood Pharmaceuticals (Boston, MA)
- … Regulatory Affairs-CMC experience and at least 5-10 years managing direct reports. Thorough understanding of relevant regulations and guidelines, including ... GI diseases and address significant unmet needs. Position Summary: Lead the Regulatory Affairs CMC function supporting process development and the manufacturing of… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …is true to the best of my knowledge. **Job Description** The Global Head of Investigations leads the global Investigations team in assessing concerns of misconduct, ... and governance, including through innovative use of technology. The Global Head of Investigation develops strong, cross-functional collaboration networks with HR,… more
- Takeda Pharmaceuticals (Boston, MA)
- …for documents such as tech transfer plan, validation or comparability assessments and regulatory submissions. + Work closely with the Head of Development to ... viral vectors and formulation of cellular therapeutics. + Previous experience in managing technical interactions with CMOs, manufacturing of cell therapies, or… more
- Pfizer (Cambridge, MA)
- …our trusted relationships with our partners, including patient advocacy organizations. The Head of Clinical Trial Diversity & Patient Engagement is responsible for ... ensuring that our clinical study populations and our resulting regulatory dossiers fully represent the racial, ethnic, gender and age diversity of the countries… more
- Takeda Pharmaceuticals (Lexington, MA)
- …in development and/or manufacturing. + Experience in the GMP environment, and regulatory affairs. + Experience managing technical capabilities in a global ... colleagues in Pharmaceutical Sciences, Supply Chain Operations, Quality Assurance and CMC- regulatory Affairs, while serving as an important point of technical… more
- Bristol Myers Squibb (Cambridge, MA)
- …analysis and reporting of studies. + Serves as Primary Clinical Representative in Regulatory interactions + Evaluates strategic options against a given Target ... clinical studies are aligned with target label indications and are designed to meet regulatory , quality, medical, and access goals + Serves as a matrix leader to… more
- Takeda Pharmaceuticals (Boston, MA)
- …slide decks, statistical analysis plans, briefing packages, clinical study reports, and regulatory labelling interactions . You will ensure these reflect the COA ... you will report to the Executive Director, Global Evidence & Outcomes Head Oncology. **How you will contribute:** + Conduct qualitative and quantitative research… more
- Takeda Pharmaceuticals (Boston, MA)
- …**Job Description** **Objectives:** + Work with the Global Medical Unit Head (GMUH), medical functional leads, immunology leadership, and global launch excellence ... and global brand strategy, incorporating cross-functional strategies (eg Commercial, Regulatory , and Region/country medical partners, and others, as appropriate). +… more
- Bristol Myers Squibb (Cambridge, MA)
- …The Associate Director, Technical Management, reports to the Technical Management Head within the Precision Medicine organization. They are accountable, with the ... medium to high complexity to support global DTs + Responsible for managing the Precision Medicine project team and deliverables, working effectively with… more
