- 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
- 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- … affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , and other relevant NNI departments to ensure alignment ... therapy area and brand level. Relationships Reports to US Head of TA. Responsible for providing interface with key...updates to leadership Product Evolution: Oversee product strategy and regulatory activities related to new clinical data or label… more
- Merck & Co. (Rahway, NJ)
- …as needed.Works in partnership internally with GCTO country operations, finance, regulatory affairs , pharmacovigilance, legal and regional operations, HQ ... appropriately in a timely manner.Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study… 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
- 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
- Kohler Co. (Palo Alto, CA)
- …hardware engineering, strategy, venture investments, sales, marketing, and partnerships. We are seeking a Head of Regulatory Affairs to own the regulatory ... ** Head of Regulatory - Kohler Ventures**...** Head of Regulatory - Kohler Ventures** _Work Mode: Hybrid_ **Location:**...of an established company. The role will engage with regulatory bodies, conduct clinical studies and trials, file … 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
- 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
- Takeda Pharmaceuticals (Bannockburn, IL)
- …States(US). + ProvidemedicalexpertisetovariousBPSdepartmentssuchasOperations,Legal, Regulatory ,Quality Assurance, IT, ... Develop and implement medical policies and procedures to support business, legal and regulatory needs including but not limited to donor advisement and medical … more
- CSL Behring (King Of Prussia, PA)
- …and often rare conditions. Could you be our next CSL Plasma Lead for Global Regulatory Affairs , Plasma? This position is located in our King of Prussia PA, ... contribute to the vision, goals and improvement of Global Regulatory Affairs and includes collaboration with external...member of the GRA CMC Leadership Team, support the Head GRA CMC in developing regulatory infrastructure… more
- Sanofi Group (Cambridge, MA)
- **Global Regulatory Affairs Lead (GRL)** **Mission statements** +...Decisions are made in alignment with the TA, GBU Head and up to the GRA LT as needed. + ... The Global Regulatory Affairs Lead (GRL) is the fully accountable decision maker...and externally as "one GRA voice" with TA, GBU Head and up to the GRA LT when needed… more
- Gilead Sciences, Inc. (Foster City, CA)
- …a direct impact. Join Gilead and help create possible, together. **Job Description** Regulatory Affairs Vendor Governance is a function within the RA Business ... and overall success of the vendor partnerships utilized by Regulatory Affairs . Gilead Sciences is seeking an...Vendor Governance team. This position will report into the Head of Vendor Governance. The candidate will be responsible… more
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