- Sanofi Group (Cambridge, MA)
- ** Global Regulatory Affairs Lead (GRL)** **Mission statements** + The Global Regulatory Affairs Lead (GRL) is the fully accountable ... of relevant pharmaceutical/biotechnology experience, including at least 10 years of relevant Regulatory Affairs experience (regionally and global ), in early… more
- Amgen (Washington, DC)
- … Affairs organization. The purpose of the Global Regulatory Affairs Senior Director is: + To lead GRTs within Amgen's GRAAS organization + To ... Senior Director supporting products in the Oncology Therapeutic Area. Global Regulatory Affairs (GRA) provides...you will lead one or more the Global Regulatory Teams (GRT) in the … more
- CSL Behring (King Of Prussia, PA)
- …serious 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 ... will contribute to the vision, goals and improvement of Global Regulatory Affairs and includes...to enable a and planning to future our requirements. Lead regulatory strategies and activities globally -… more
- Teva Pharmaceuticals (West Chester, PA)
- …timelines. + Accountable to Global Regulatory Lead and Global Regulatory Affairs , with matrixed accountability to Project Management. + Regularly ... Innovative Medicine Dossier Project Manager, a key member of Global Regulatory Affairs , will be...adaptations needed as challenges arise. + In collaboration with regulatory lead and project leader, conduct scenario… more
- J&J Family of Companies (Raritan, NJ)
- …+ Ensures that CMC regulatory strategy is aligned with strategies of global regulatory Affairs , therapeutic areas and regional functions. + Assures ... according to scientific and risk-based principles. + Participates as regulatory lead on CMC/VCM teams and represents...and expectation + Participates in initiatives within CMC-RA or Global Regulatory Affairs + Conducts… more
- Randstad US (Chicago, IL)
- global regulatory affairs strategist. +...for assigned due diligences, under the direction of the Global Regulatory Strategy Lead (GRSL). An ... be responsible for the assessment of information that will lead to a regulatory recommendation. In addition,...experience. Minimum of 10 years in Regulatory Affairs . + In depth and relevant Global … more
- J&J Family of Companies (Raynham, MA)
- Senior Regulatory Affairs Program Lead ..., Quality Engineering, Product Management, Labeling, as well as global Regulatory Affairs affiliates. * ... Family of Companies, is currently recruiting for a **Senior Regulatory Affairs Program Lead ** ,...* A demonstrated track record of developing and executing global regulatory strategies that align with business… more
- Astrix Technology (Houston, TX)
- Global Regulatory Affairs Manager II Regulatory Affairs Houston, TX, US Pay Rate Low: 65.00 | Pay Rate High: 75.72 + Added - 08/03/2024 Apply for Job ... - with complementary businesses in Surgical and Vision Care. ** Global Regulatory Affairs Manager II**...compiling and authoring EU MDR-compliant STeD files. + Independently lead development, remediation, planning, and authoring of EU MDR… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …to ensure registration strategies adhere to therapeutic area direction and corporate objectives. Serve as Global Regulatory Lead or US regulatory lead ... to impact development programs. Additionally, this position interacts with Regulatory Affairs (RA) team members, cross-functional team...or global representation on project teams; may lead regulatory teams for more complex projects.… more
- J&J Family of Companies (Irvine, CA)
- … Affairs Program Lead for International Registration, as part of the Regulatory Affairs Global Execution team, located in Irvine, CA. At Johnson & ... Senior Regulatory Affairs Program Lead - 2406184334W **Description** The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Tech sector… more
- Sanofi Group (Cambridge, MA)
- …the advertising and promotion of prescription drugs and biologics. Essential Functions + Represents Global Regulatory Affairs (US RA AdPromo) as a member of ... Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs),...Consults with senior management and provides input to the global organization as needed. + Contributes US RA AdPromo… more
- AbbVie (Lake Bluff, IL)
- …Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director, Regulatory Affairs , Strategic Global Labeling - Combination ... submissions (pre and post approval) with an understanding of Global requirements to lead the Labeling Sub...trends and best practices in combination product and device regulatory affairs , review and comment on changing… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. **Summary** Responsible for leading and developing global regulatory strategy for assigned development projects. Represents ... global strategy. + Responsible for ensuring aligned global regulatory strategy is endorsed by GPT...or More Years of proven experience in a regional regulatory lead role + 7 or More… more
- System One (Florham Park, NJ)
- Title: Manager/Senior Manager US Regulatory Affairs - Global Development Projects Location: Remote Type: Contract Rate: 52-70 (DOE) Start Date: ASAP Leading ... located in NJ is hiring a Manager/Senior Manager US Regulatory Affairs - Global Development...and requirements. + Ability to simultaneously plan, coordinate and lead activities on multiple projects. + Ability to self-direct… more
- Amgen (Washington, DC)
- …over 10 million patients worldwide. It's time for a career you can be proud of. Global New Asset Medical Affairs Lead - Inflammation (GNAMAL) **Live** **What ... Inflammation Therapeutic Area Head. + Serves as the Global New Asset Medical Affairs Lead...interactions (eg, OLs, advocacy groups, payers) + Familiarity with global regulatory organizations, guidelines, and practices +… more
- Sanofi Group (Bridgewater, NJ)
- **US Regulatory Affairs Lead for Personal Care Brands and Unisom - Gold Bond, Cortizone-10, Selsun Blue, ACT Mouthwash and Unisom Dietary supplements, OTC ... the world._ **Our Team:** We're immediately hiring a US Regulatory Affairs Lead for Personal...the CHC aligned strategy, are complete, accurate, compliant with global and/or local submission standards and are organized in… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational ... leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may...experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience… more
- Amgen (Thousand Oaks, CA)
- … policy and regulatory intelligence teams. Reporting to the Senior Vice President, Global Regulatory Affairs , this key senior leadership role serves as a ... global regulatory initiatives. The Head of Regulatory Affairs Policy & Intelligence leads a...Clinical Development, and others to align Global Regulatory and R&D policy priorities + Lead … more
- Amgen (Washington, DC)
- …patients worldwide. It's time for a career you can be proud of. **Medical Director, Global Medical Affairs Lead , Obesity - US, Remote** **Live** **What you ... the commercialization process. You will also Serve as the Global Medical Affairs Lead (GMAL)...Leaders, advocacy groups, patients, payers, vendors) + Familiarity with global regulatory organizations, guidelines, and practices +… more
- Olympus Corporation of the Americas (Westborough, MA)
- …purpose and our core values by staying **True to Life.** **Job Description** The Global Lead Medical Affairs - Gastroenterology (GLMAG) is a board-certified, ... application of prior clinical knowledge and medical training to lead internal stakeholders within the Gastroenterology therapeutic area while...as societal engagement. + Clinical Research: To support the Global Head of Clinical Affairs in the… more