- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as a US Lead , Global Regulatory Policy and Innovation where you ... serve as US expert and subject matter lead for regulatory policy and advocacy activities,...Policy Innovation, you will report to Executive Director & US Head, Global Regulatory Policy… more
- AbbVie (Waltham, MA)
- …Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory Lead , Global Regulatory Strategy, ... TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead ...two or more major regions in addition to the US , such as EU or Japan. Strong global… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director, Global Regulatory Lead , GI & Inflammation where you will ... define, develop, and lead global strategies to maximize global ...technical success for the solutions. + Accountable for all US FDA submissions and approvals of project(s) of responsibility… more
- Novo Nordisk (Lexington, MA)
- … regulatory expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute ... human health starts here and that patients rely on us . We're changing lives for a living. Are you...and deliver on associated regulatory activities + Lead the Global Regulatory Matrixed… more
- Sanofi Group (Cambridge, MA)
- **Job title: Global Regulatory Lead ** +...Life Science, or related field) is preferred. **Why choose us ?** + Bring the miracles of science to life ... possible. Ready to get started? **Main responsibilities:** + As Global Regulatory Affairs Lead (GRL),...14 weeks' gender-neutral parental leave. Sanofi Inc. and its US affiliates are Equal Opportunity and Affirmative Action employers… more
- Takeda Pharmaceuticals (Boston, MA)
- …our Global Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams ... shine? Join us as an Associate Director, Global Regulatory Project Management and Strategic Planning...**How you will contribute:** + Partnering with the program Global Regulatory Lead (GRL), co-… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …as an Associate Director, Global Reg Affairs Device, PDT in our Global Regulatory Affairs CMC & Device organization in the Plasma-Derived Therapies Business ... Unit at Takeda. The Global Regulatory Affairs CMC & Device organization...of the medical, ancillary, or combination device in the United States and international markets + The… more
- Merck (Boston, MA)
- …and obtain shortest time to approval by regulatory agencies. + Functions as global regulatory lead assigned to programs where the compound is ... submissions and associated documentation. + Provides expertise as the Global Regulatory Lead to Product...in certain states and cities within the United States . Final determinations with respect to… more
- Takeda Pharmaceuticals (Boston, MA)
- …Management + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... therapies to patients worldwide. Join Takeda as Associate Director, Global Labeling Lead where you will be...Represents Global Labeling at Global Regulatory Team (GRT) + Liaises with US … more
- Merck (Boston, MA)
- …review and final approval for all submissions and associated documentation. Provides expertise as Global Regulatory Lead to Product Development Teams and ... targeted product labeling + Provide expert advice as the Global Regulatory Lead to Product...in certain states and cities within the United States . Final determinations with respect to… more
- Sanofi Group (Cambridge, MA)
- …of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Strategist (RS) leverages their ... strategy, to enable and drive the execution of aligned US , EU and/or global regulatory ...management of products. + May serve as a regional/local regulatory lead and point of contact with… more
- Sanofi Group (Cambridge, MA)
- …of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), you will leverage your regulatory expertise ... strategy, to enable and drive the execution of aligned US , EU and/or global regulatory ...governance, and committees + May serve as a regional/local regulatory lead and point of contact with… more
- Takeda Pharmaceuticals (Boston, MA)
- … Regulatory Affairs Marketed Products you will define, develop and lead global strategies to maximize global regulatory success towards achievement of ... technical success for the solutions. + Accountable for all US FDA submissions and approvals of project(s) of responsibility...Partner with global market access colleagues to Lead interactions with joint regulatory /health agency/HTA bodies… more
- AbbVie (Waltham, MA)
- …with multiple driver indications within a Therapeutic Area and supports the Manager ( Global Regulatory Lead (GRL), Associate Director, or Director), in ... Job Description Responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …Drive process enhancement and continuous improvement initiatives in Patient Access + Lead regulatory inspections and audit support for Patient Access, including ... of continuous improvements, training and best practices to ensure regulatory compliance and consistency for Takeda Patient Access programs....You will report to the Head of Patient Access, Global Medical. **How you will contribute:** + Lead… more
- Takeda Pharmaceuticals (Boston, MA)
- …Demonstrated ability to lead cross-functional teams, develop and implement global regulatory strategies, facilitate approvals, resolve complex issues, and ... managing and adhering to timelines. + Broad experience in US and Global Regulatory Affairs,...partner/health authority audits and inspections. Leadership + Ability to lead , motivate, mentor, and manage a diverse team in… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. Join Takeda as a Manager, Global Regulatory Affairs CMC Submission Management where you will support the ... by GRA. + Collaborating with cross-functional teams to develop project plans for global regulatory submissions (IND/ IMPD/ CTA/ MAA) and ensure alignment with… 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 ... sites/functions. + Serve as a member of the Global Regulatory Affairs Leadership Team, influencing the...lead complex outsourcing projects. + Deep understanding of regulatory information management + Savvy and effective negotiation skills… more
- Takeda Pharmaceuticals (Cambridge, MA)
- … regulatory guidance on Material Sciences to product teams in line with global regulatory strategies + Develops strategies, tools and trainings to develop the ... regulatory filings through clinical development and commercial product lifecycle + Lead regulatory strategy, briefing book authoring and meetings with … more
- Pfizer (Cambridge, MA)
- …compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or ... **ROLE SUMMARY** The Global Development Lead will be responsible...any location outside of the United States . Relocation assistance may be available… more