- Novo Nordisk Inc. (Plainsboro, NJ)
- …Therapy Area (TA) head is accountable for setting an integrated medical affairs strategy, scientific engagement plan and execution of that plan for the relevant ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...relevant functions As a senior level representative of medical affairs , the TA head will work closely… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …More Years Pharmaceutical industry and Regulatory operations required.4 or More Years regulatory affairs including filing NDA and sNDA. BLA filing to FDA ... research areas centered around rare diseases and immune disorders.Summary The Director, Head of Global Dossier Planning, Regulatory Operations is responsible for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …including veterans and people with disabilities.SummaryThis position leads the Global Regulatory Affairs (GRA) Global Labeling function, combining knowledge of ... 10 or More Years pharmaceutical industry experience required- 10 or More Years regulatory affairs experience, including direct experience with CCDS, US and and… more
- Merck & Co. (Rahway, NJ)
- …and devices. The Executive Director, as a senior member of the Global Regulatory Affairs and Clinical Safety: Chemistry, Manufacturing and Controls Organization ... Their role is pivotal in fostering alignment and global execution across Regulatory Affairs , R&D, Manufacturing, and our Commercial division, ensuring compliance… more
- Novo Nordisk Inc. (Chicago, IL)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Rahway, NJ)
- …payment timelines.Works in partnership internally with GCTO country operations, finance, regulatory affairs , pharmacovigilance, legal and regional operations, HQ ... to produce safe, effective, innovative medicine.Under the oversight of the Sr. COM, Head COMs or CRD, the person is responsible for budget/finance aspects, for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and experience working in a matrix environment with other functional groups (eg. Regulatory , Medical Writing, Med Affairs , Commercial) In-depth knowledge of Good ... areas of Global Development and US Clinical, Medical and Regulatory (CMR). Your skills, dedication and ambition will help...and due diligence teams Is a member of the Head Quarter Trial Management Council (HQTM Council) Is sponsor/Steering… more
- DivIHN Integration Inc (Green Oaks, IL)
- …contact one of our Talent Specialists Meghna at ### Rashi at ### Title: Regulatory Affairs Specialist Location: Abbott Park, IL Duration: 7 Months Description ... latitude is expected. Typically reports to a manager or head of a unit/department. Main purpose of role As...role As an individual contributor, the function of a Regulatory Affairs Specialist is to provide support… more
- DivIHN Integration Inc (North Chicago, IL)
- …one of our Talent Specialists Meghna at ### Rashi at ### Title: Specialist Regulatory Affairs Duration: 7 Months Location: Abbott Park, IL/ Columbu, OH ... latitude is expected. Typically reports to a manager or head of a unit/department. Accountability / Scope: As the...unit/department. Accountability / Scope: As the professional in the Regulatory Affairs function, the individual will assist… more
- DivIHN Integration Inc (Alameda, CA)
- …a unit/department. Please look for associates who have background not just in Regulatory Affairs but also from engineering, quality, and manufacturing, who are ... latitude is expected. Typically reports to a manager or head of a unit/department. Emerging Regulations team- manages regulations...willing to look for a career in Regulatory Affairs . Interviews: 1 interview with hiring… more
- Amgen (Thousand Oaks, CA)
- …and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses. ** Head of Regulatory Affairs Policy & Intelligence** **Live** ... do** Let's do this. Let's change the world. In this vital role as Head of Regulatory Affairs Policy & Intelligence you are responsible for shaping Amgen's … more
- Philips (Cambridge, MA)
- ** Head of Regulatory Affairs , S&RC** Lead and manage global teams of Regulatory Affairs professionals responsible for all Regulatory activities ... if:** + Bachelor's degree, preferably in a life-scientific field, and a Regulatory Affairs Certification + Strong proven track record of leading an organization… more
- Gilead Sciences, Inc. (Foster City, CA)
- …operates in more than 35 countries worldwide, with headquarters in Foster City, California. ** Head of CMC Regulatory Affairs - Small Molecules** **KEY ... RESPONSIBILITIES** The Head of CMC Regulatory Affairs - Small Molecules is responsible for Gilead's global portfolio of small molecule products in CMC … more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …primarily to marketed products in US and Canada. In addition, the Senior Director, Commercial Regulatory Affairs , in collaboration with Head , Regulatory ... creating hope for all facing illness. The Senior Director, Commercial Regulatory Affairs , is responsible for the development and execution of the post-approval… more
- Gilead Sciences, Inc. (Foster City, CA)
- …guidelines and regulations to ensure approvability globally. The incumbent will report directly to Head of CMC Regulatory Affairs - Systems and Operations at ... with headquarters in Foster City, California._ **Senior Director - Analytical Regulatory Science** KEY RESPONSIBILITIES The Sr Director, Analytical Regulatory … more
- Equitable (New York, NY)
- …Regulatory Affairs practice group of the Equitable Law Department reporting to the Head of Regulatory Affairs . The Regulatory Affairs practice ... group is responsible for the Company's legislative and regulatory advocacy efforts, including identifying potential avenues for such advocacy and devising strategies… more
- Actalent (New Prague, MN)
- …developments and modifications meet all regulatory criteria. + Collaborate with the Head of Regulatory Affairs and Quality Assurance (RA/QA) to interpret ... efficiency, and contribute to the organization's overall performance in quality and regulatory affairs . + Support and correspond with clinical study… more
- Takeda Pharmaceuticals (Boston, MA)
- … Affairs CMC team, you will report to the Executive Director and Head , CMC Regulatory Affairs - Pharmaceuticals. **How you will contribute:** + ... with Global CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives. You will also influence changing… more
- Takeda Pharmaceuticals (Boston, MA)
- …CMC Pharmaceuticals, Oligonucleotides team, you will report to the Executive Director and Head , CMC Regulatory Affairs , Pharmaceuticals. **How you will ... CMC Pharmaceuticals, Oligonucleotides where you will lead the GRA CMC Pharmaceuticals regulatory team in the development and implementation of global CMC … more
- Ascendis Pharma (Princeton, NJ)
- The Head of US Medical - Endocrine Medical Affairs will report to the US General Manager with primary responsibility to lead the US Medical Directors and ensure ... Ascendis Pharma. . Works closely with Compliance, Legal and Regulatory to ensure that all US Medical Affairs... Regulatory to ensure that all US Medical Affairs activities and services are fully compliant with Ascendis… more
