- Takeda Pharmaceuticals (Boston, MA)
- …new plasma-derived therapies for patients with immunologic, hematologic, and other complex diseases. The Head of Global Regulatory Affairs Labeling is a key ... managing and adhering to timelines. + Broad experience in US and Global Regulatory Affairs ,...an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health… more
- Meta (Seattle, WA)
- …in electromechanical devices and software as a medical device (SaMD). **Required Skills:** Head of Medical Devices Regulatory Affairs Responsibilities: 1. ... **Summary:** Reality Labs is seeking an experienced medical devices regulatory affairs professional to lead the ...recruiting process. If you need any assistance or accommodations due to a disability, please let us know at… more
- Ascendis Pharma (Palo Alto, CA)
- …The position will be based in Palo Alto, CA and reports directly to the Head of Regulatory Affairs . Key Responsibilities + Responsible for strategic and ... biopharma company with offices in Denmark, Germany, and the United States . Today, we're advancing programs in...business, from drug development to marketing. The Senior Manager, Regulatory Affairs will be responsible for supporting… more
- Philips (Chicago, IL)
- …manufacturing procedures to maintain quality and regulatory compliance. + Reporting to the Head of Regulatory Affairs for AM&D, you will communicate with ... The Senior Regulatory Affairs Program Manager will play...+ Develop and prepare product registration submissions for the US , Canada, EU, and support submission preparation for all… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Pharmaceutical Development & Manufacturing (PDM) Project teams. The role will report directly to Head of CMC Regulatory Affairs - Biologics at Gilead. ... City, California. **About the Role:** The Senior Director, CMC Regulatory Affairs for Biologics is responsible for...conditions of the applicable plans. **For jobs in the United States :** As an equal opportunity employer,… more
- New York State Energy Research and Development Aut (New York, NY)
- … Affairs will report directly to the NY Green Bank's Managing Director, Head of Legal and Regulatory Affairs and be charged with anticipating ... researching and providing legal advice on operational (internal law), regulatory (external law), and transactional matters. Primary Responsibilities The Director,… 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 ... to the terms and conditions of the applicable plans. **For jobs in the United States :** As an equal opportunity employer, Gilead Sciences Inc. is committed… 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 international regulations and policies setting processes of major regulatory agencies (eg US FDA, EU, PMDA,...an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health… more
- Ascendis Pharma (Princeton, NJ)
- The Head of US Medical - Endocrine Medical Affairs ...Legal and Regulatory to ensure that all US Medical Affairs activities and services are ... Directors to drive the development and execution of the US Medical Affairs strategy and tactics in...fully compliant with Ascendis SOPs and US as well as global regulatory and… more
- AbbVie (Cambridge, MA)
- …on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director Regulatory Affairs Therapeutic Area Head , GRS, is responsible for ... the management of global regulatory leads with product and disease state expertise for...in at least 2 regions in addition to the US (UK, EU, JAPAC, etc.) + NOTE: Higher education… more
- Gilead Sciences, Inc. (Foster City, CA)
- …include but are not limited to: + Partner with stakeholders (eg, Medical Affairs , Business Conduct, Development, Regulatory Affairs , Legal and Commercial) ... company. Reporting to the Executive Director of Global Medical Affairs , Insights, Digital and Analytics this individual will be...conditions of the applicable plans. **For jobs in the United States :** As an equal opportunity employer,… more
- Takeda Pharmaceuticals (Boston, MA)
- …We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver** **_Better Health and a Brighter ... Neuroscience Therapeutic Area (TA) including hiring of Global Medical Affairs (GMA) professionals covering different therapeutic indications and devising/implementing… more
- AbbVie (South San Francisco, CA)
- …you will be added to our talent pipeline and considered for future opportunities. Global Regulatory Affairs Strategy roles ( US and Canada) can be based in ... requirements. 6. Responsible for products within a Therapeutic Area & support the Global Regulatory Lead (GRL) & Therapeutic Area Head with the development &… more
- Pfizer (New York, NY)
- …Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States . Regulatory Affairs ... regulatory matters in all markets outside of the US . The incumbent will have a global strategic mindset...are aligned based on the location of hire. The United States salary range provided does not… more
- Takeda Pharmaceuticals (Boston, MA)
- …Operations at Takeda will be responsible for formulating and implementing the Global Regulatory Affairs Operations (GRA-Ops) vision and strategy to achieve a ... Responsibilities:** + Be a strategic thought partner to the Head of Regulatory about complex problems, current...sites/functions. + Serve as a member of the Global Regulatory Affairs Leadership Team, influencing the operations… more
- AbbVie (South San Francisco, CA)
- …requirements. + Responsible for products within a Therapeutic Area & support the Global Regulatory Lead (GRL) & Therapeutic Area Head with the development & ... internal cross-functional team who may contribute to regulated communication on Regulatory /FDA issues including Public Affairs , Clinical Development, Legal, &… more
- SAP (Washington, DC)
- …Director of US Government Affairs will report to the Vice President & Head of US Government Affairs who will work together with this individual to ... seeks must have an in depth understanding of the US legislative and regulatory process including extensive...impact SAP in close consultation with the Vice President, Head of US Government Affairs … more
- Englewood Lab, Inc (Totowa, NJ)
- …document submissions to regulatory agencies under the direct supervision of the Head of Quality. + Assist the Manager during periodic regulatory reviews, ... Responsibilities + Assist the Manager during cGMP, Environmental, and Regulatory audits. + Assist the Manager to create and...Familiar with quality management system (QMS) in compliance with US 21CFR 210, 211. + Maintain familiarity with changing… more
- Chr. Hansen, Inc. (West Allis, WI)
- …endless. We're here to better our world with biology. Join us as our new Head of Regulatory , Americas Human Health Biosolutions This is a new role due to our ... be based out of our West Allis, WI or Franklinton, NC location. Welcome to Regulatory Affairs and Product Safety (RAPS) On this team we have a clear team brand… more
- Gilead Sciences, Inc. (Foster City, CA)
- …, US Commercial, US Government Affairs and Policy, US Public Affairs , US Regulatory , and US legal and compliance + Represent US ... regulatory and legal (Business Conduct) requirements for US Medical Affairs activities. + Able to...conditions of the applicable plans. **For jobs in the United States :** As an equal opportunity employer,… more