- Actalent (Gaithersburg, MD)
- … Regulatory Affairs will spearhead the creation and execution of a unified regulatory strategy , encompassing regulatory operations, to ensure and sustain ... This role involves building and nurturing strong relationships with regulatory bodies, particularly the FDA. The Director ...current team members, and recruiting new talent. + US Regulatory Strategy : Develop and execute US-specific… more
- Providence (Renton, WA)
- …+ Oversees and coordinates the analysis of state and federal rulemaking. Coordinates with Director , Regulatory Strategy to develop response. + Develops and ... **Description** **THE ROLE** The Director Analytics Business Intelligence (Reimbursement, Regulatory ...oversees implementation of Reimbursement data strategy . + Develops tools to evaluate regulatory … more
- Duke Energy (NC)
- …recognition for your work, and competitive pay and benefits. Job Summary This Rates & Regulatory Strategy Director will support and lead retail regulatory ... experienced through the rate proceedings. Activities include: + research and strategy development - identify potential regulatory issues/hurdles and propose… more
- AbbVie (Chicago, IL)
- …Product Safety Teams, Safety Review Board, and other stakeholders on risk management regulatory strategy + Partner with global regulators and industry groups on ... Instagram, YouTube and LinkedIn. Job Description Purpose: Promotes risk management strategy excellence through the development and application of a structured,… more
- J&J Family of Companies (Columbus, OH)
- …Document, Draft Target Label, Target Product Profile, Compound Development Plan, and Regulatory Strategy Plan) through active participation at relevant meetings ... Director , Regulatory Medical Writing (1 of 4) -...(eg, Labeling Working Group, Regulatory Strategy meetings, Functional Team Meetings with SPML). +… more
- Takeda Pharmaceuticals (Boston, MA)
- …tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory ... therapies to patients worldwide. Join Takeda as a Senior Director , Global Regulatory Lead, GI & Inflammation...needs and anticipates such changes to lead adaptations to regulatory strategy . + Ensures project team colleagues,… more
- Takeda Pharmaceuticals (Boston, MA)
- …tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory ... bring life-changing therapies to patients worldwide. As an Associate Director , Global Regulatory Affairs Marketed Products you...expertise to guide team in established and building appropriate regulatory strategy . + Strong oral and written… more
- Merck (North Wales, PA)
- …the promotional review divisions of FDA (OPDP/APLB) or experience developing/leading the regulatory strategy for a product filing/launch + Understanding of the ... **Job Description** Reports to the Director /Senior Director in the Office of...strategy discussions and extended team meetings and providing regulatory guidance and perspective on marketing strategies and promotion… more
- Merck (Rahway, NJ)
- …mitigation measures. + Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of increasing complexity. + Lead ... **Job Description** **Principal Scientist / Director , GLOBAL REGULATORY CMC Biologics (R5)**...by site or organization, with Friday designated as a remote -working day, unless business critical tasks require an on-site… more
- Takeda Pharmaceuticals (Columbus, OH)
- …the best of my knowledge. **Job Description** **About the role:** **Associate Director , Nonclinical Regulatory Writing and Submission Support,** **_Oncology and ... that enables you to engage in meaningful work? Join us as an _Associate Director - Nonclinical Regulatory Writer_ _and Submission Support_ reporting to the… more
- Bristol Myers Squibb (Princeton, NJ)
- …7-10+ years Pharmaceutical industry experience, including multi-disciplined experience, 6+ years CMC regulatory strategy . + Knowledge of CMC regulatory ... database to address external questions regarding drug products. The CMC Regulatory Associate Director , Biologics is responsible for content development,… more
- Takeda Pharmaceuticals (Columbus, OH)
- …plan and deliver GRT goals and regulatory submissions in accordance with regulatory strategy for moderately complex programs and submissions. + Partner with ... empower you to shine? Join us as an Associate Director , Global Regulatory Project Management and Strategic...regulatory goals are cascaded and that the Global Regulatory Strategy Plan is operationalized and executed… more
- Takeda Pharmaceuticals (Columbus, OH)
- … submission documents. Collaborate with all Takeda regions to ensure a medical writing regulatory document strategy is created and executed upon for all products ... lead writer for important regulatory response documents and key components of regulatory submissions. + The Associate Director , Medical Writing is seen as an… more
- AbbVie (North Chicago, IL)
- …with other cross-functional team members. The real-world evidence generation strategy encompasses (a) regulatory required pharmacoepidemiology studies to ... of capabilities/methodology to bridge knowledge gaps. The Epidemiology Associate Director provides expertise in regulatory pharmacoedemiology across functions.… more
- Vanderbilt University (Nashville, TN)
- The Director of Competition and Regulatory Policy is responsible for the development and implementation of the policy agenda and research portfolio associated ... at the Vanderbilt Policy Accelerator for Political Economy and Regulation. The Director will spend a significant amount of time providing strategic policy guidance… more
- Bristol Myers Squibb (Madison, NJ)
- …careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of ... will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input. In collaboration with the Global … more
- Takeda Pharmaceuticals (Columbus, OH)
- …to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be responsible for the development ... and implementation of labeling content and strategy of multiple assigned products in various stages of...assures that Takeda labeling content and processes conform to regulatory requirements. Management of Local Exceptions and LOC Interactions… more
- Takeda Pharmaceuticals (Lexington, MA)
- …true to the best of my knowledge. **Job Description** Join Takeda as an Associate Director , US Advertising & Promotion Regulatory Review out of our Lexington, MA ... assigned US products and/or compounds. + Interpret complex issues in relation to regulatory requirements and promotional strategy . + Mentor and develop staff.… more
- CommonSpirit Health (Englewood, CO)
- …in the community. **Responsibilities** This is a remote position. The System Director of System Strategy will support the development and execution of ... to our organization's values and faith-based mission. The System Director of System Strategy is a critical...to ensure alignment with organizational culture, values, and goals. Regulatory Compliance and Risk Management: Ensure compliance with … more
- Amgen (Washington, DC)
- …proud of. **Associate Director Global Clinical Program Management, Obesity - US, Remote ** **Live** **What you will do** Let's do this. Let's change the world. In ... vital role you will coordinate and lead all aspects of the operational strategy , planning, risk assessment and mitigation, and overall delivery of Obesity clinical… more