- Lundbeck (Deerfield, IL)
- …to candidates anywhere in the greater United States ** **SUMMARY:** The Director , US Regulatory Affairs Global Strategic Labelling, oversees the ... Director US Regulatory Global Strategic Labelling - Remote Opportunity Requisition ID: 5211 Location: Deerfield, Illinois, US Do you want to join a… more
- Takeda Pharmaceuticals (Columbus, OH)
- …to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Regulatory Project Management and Strategic Planning - ... Affairs Team. **How you will contribute:** + As Associate Director , Global Regulatory Project Management...regulatory operational advice and making reasoned decisions on regulatory operational issues. **More about us :** At… more
- J&J Family of Companies (Raritan, NJ)
- Senior Director , Global Regulatory Leader, CAR-T Therapy - 2406186120W **Description** Johnson & Johnson is currently seeking a Senior Director , ... supports their efforts to have a positive impact on their communities. The Senior Director , Global Regulatory Leader, CAR-T Therapy will be responsible for… more
- Amgen (Washington, DC)
- …It's time for a career you can be proud of. ** Regulatory Affairs Senior Director - Global Regulatory Leader - Oncology** **Live** **What you will do** ... Director supporting products in the Oncology Therapeutic Area. Global Regulatory Affairs (GRA) provides global...+ Negotiation skills **Thrive** **What you can expect of us ** As we work to develop treatments that take… more
- Lilly (Indianapolis, IN)
- …who are determined to make life better for people around the world. **Senior Advisor/ Director , Global Regulatory Affairs - CMC, Small Molecules** At Eli ... for people around the world. Lilly is looking for regulatory CMC scientists to join us in...who need them all over the world. The Senior Advisor/ Director in Global Regulatory Affairs… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …aspirations. Join Gilead and help create possible, together. **Job Description** As a Director , Global Regulatory Affairs, Precision Medicine you will ... in therapeutic trials with global and local regulatory requirements (such as US FDA and...conditions of the applicable plans. **For jobs in the United States :** As an equal opportunity employer,… more
- AbbVie (Boston, MA)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director , Global Regulatory Lead, is responsible for developing and ... for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands...two or more major regions in addition to the US , such as EU or Japan. Strong global… more
- AbbVie (Lake Bluff, IL)
- …on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director , Regulatory Affairs, Strategic Global Labeling - Combination ... terminology, guidelines, standards, etc. + Experience developing and implementing successful global regulatory labeling strategies. + Experience with InDesign a… more
- AbbVie (Boston, MA)
- …Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director , RA Global Regulatory Strategy, US & Canada (Oncology) is responsible ... a product within a Therapeutic Area and supports the Global Regulatory Lead (GRL, Director ),...skill at implementing successful US and Canada regulatory strategies; global regulatory experience… more
- J&J Family of Companies (Trenton, NJ)
- Director , Global Regulatory Leader...technology assessments, payor demands) + Lead the preparation of regulatory dossiers for submissions to US FDA. ... of 2) - 2406184564W **Description** Johnson & Johnson Innovative Medicine is recruiting for a Director , Global Regulatory Affairs Leader (1 of 2) located in… more
- Merck (Rockville, MD)
- …extramurally to support the company's enterprise policy agenda. **Responsibilities of the Director , US Regulatory Policy, will include:** + Proactively ... regulatory policy is shaped and developed in the United States . + Representing the company in...under the supervision of the Executive Director , US Lead, US Regulatory Policy.… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …for providing oversight of the preparation, alignment and formulation of strategy for US and/or global regulatory submissions. This position ensures ... Dossier Submissions: Provides oversight of the preparation, coordination or monitoring of US and/or global regulatory submissions. Advises on US and/or … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …**Summary** This role is responsible for leading and mentoring a dynamic and global Regulatory Intelligence & Policy team, through direct and indirect line ... that DS is prepared to meet new or proposed global regulatory requirements and that DS has...collecting, analyzing, synthesizing and communicating intelligence relating to the US regulatory framework. ** Regulatory Policy**… more
- Novo Nordisk (Lexington, MA)
- …make a difference? The Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational ... human health starts here and that patients rely on us . We're changing lives for a living. Are you...medicines. You will lead a global regulatory team to… 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...drug development preferred. + Ability to interpret and understand US regulations governing the pharmaceutical industry; general global… more
- Lilly (Indianapolis, IN)
- …tactical, and operational support for market registrations and post-approval submissions. The regulatory scientist in Global Regulatory Affairs - CMC ... Chemistry, Manufacturing and Control (CMC) scientists to join us in developing and bringing life-changing new medicines to...of CMC drug development science(s) + Knowledge of CMC global regulatory requirements and guidelines related to… more
- Boehringer Ingelheim (Ridgefield, CT)
- …+ As a regulatory professional, you will contribute to a holistic global strategy for assigned CRM projects. Your leadership and in-depth expertise will enable ... compliance. + You will lead the development and implementation of cutting-edge global strategic regulatory strategies. Your role will involve assessing … 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...Preparation of updated Core Data Sheets, and EU and US Documentation: Independently manages, prepares and implements regulatory… more
- Teva Pharmaceuticals (West Chester, PA)
- …a difference, and new people to make a difference with. **The opportunity** The Sr. Director , Global Regulatory Affairs CMC is responsible to oversee and ... (Biologic Products) Date: May 15, 2024 Location: West Chester, United States , Pennsylvania, 19380 Company: Teva Pharmaceuticals...with eCTD regulatory filings ⦁ Knowledge of US and global content and regional requirements… more
- Teva Pharmaceuticals (West Chester, PA)
- …making a difference, and new people to make a difference with. **The opportunity** The Director , Global Regulatory Affairs, is a strategic role that will be ... or Remote) Date: Apr 29, 2024 Location: West Chester, United States , Pennsylvania, 19380 Company: Teva Pharmaceuticals...your day** + Responsible for ensuring timely development of regulatory strategies through a global regulatory… more