- Insmed Incorporated (Bridgewater, NJ)
- …, Toxicology, is a key member of the nonclinical safety team, reporting to the Executive Director , Head of Toxicology and Molecular Mechanisms. In this role, you ... DABT/DACVP certification preferred. Minimum of 15 years of experience as a regulatory toxicologist (study director /monitor and/or project lead) in the… more
- Merck & Co. (Rahway, NJ)
- …and a-vision to influence the regulatory environment.Nature and Scope of Position:The Director reports to the Executive Director of SMAR&D and will ... and sterile products.- It also includes strategic partnering with CMC and Regulatory in aspects of control...biochemical promcesses, parenteral, oral, and specialty dosage formulations.- The director should be well engaged with regulatory … more
- Aequor (Thousand Oaks, CA)
- …small molecule development and commercial lifecycle maintenance, product stability programs, CMC regulatory filings, risk assessment, and Quality Management ... chromatography, and data analytics and visualization knowledge. Job Summary: The Product Quality Director is the champion for a product team as the Product Quality… more
- Takeda Pharmaceuticals (Boston, MA)
- …Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. **How you will ... therapies to patients worldwide. Join Takeda as a Senior Director , GRA - CMC Pharmaceuticals- Small Molecule...CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives.… more
- BeiGene (Emeryville, CA)
- …stage through clinical proof of concept. + Lead cross-functional team to author CMC / quality sections of regulatory submissions (INDs/CTDs). + Building scope and ... processes and analytics for cell therapy products. + Assembling relevant CMC data and authoring regulatory filing documents ( CMC sections) and responses to… more
- Emory Healthcare/Emory University (Atlanta, GA)
- …Master in Management (MiM) Program. Reporting to the Assistant Dean & Executive Director for the Undergraduate Career Management Center and collaborating ... of our academic community. **Description** The Goizueta Business School is seeking a Director to lead the career development and recruiting efforts for the newly… more
- Merck (West Point, PA)
- …the GMP manufacturing of vaccine and biologic drug substances (DS) as the Executive Director for the Bioprocess Clinical Manufacturing & Technology (BCMT) ... the department's representative for WP (West Point, PA) site-wide Executive Council, WP Site Governance team, and Global Quality...in preparation for production; and collaborate with Manufacturing and CMC Regulatory in the preparation of … more
- Lilly (South San Francisco, CA)
- …life better for people around the world. Purpose: The purpose of the Senior Director / Executive Director , Global Regulatory Affairs, Global Regulatory ... Industry-relatedexperiencein regulatoryaffairsand/ordrugdevelopmentexperiencefor 10years + Direct experience in clinical and CMC regulatory sciences + Experience in applicable… more
- Merck (West Point, PA)
- …in the process development and manufacturing of vaccine drug substances (DS) as an Executive Director for Discovery Interface & New Platforms (DINP), located in ... process development and clinical manufacturing for all of our company's pipeline. The Executive Director will be responsible for interfacing with our Discovery… more
- Bill and Melinda Gates Foundation (Seattle, WA)
- …Consulting* Your Role The Bill and Melinda Gates Foundation is seeking a Deputy Director of Chemistry, Manufacturing and Controls ( CMC ) to join our Integrated ... Development (IDev) team. The CMC Deputy Director will lead a team...deliverability targets. + Play a strategic role in addressing CMC -related issues pertaining to regulatory interactions and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …stakeholders. Collaborate with CMOs, Quality Control, Quality Assurance, External Manufacturing, Regulatory CMC , Process Development, Supply Chain and other ... regulatory inspections/audits. Participate in writing, reviewing and approving CMC sections of US and international clinical trial applications, regulatory… more
- Merck (Rahway, NJ)
- …vision to influence the regulatory environment. **Nature and Scope of Position:** The Director reports to the Executive Director of SMAR&D and will lead ... and sterile products. It also includes strategic partnering with CMC and Regulatory in aspects of control...biochemical promcesses, parenteral, oral, and specialty dosage formulations. The director should be well engaged with regulatory … more
- Bristol Myers Squibb (Princeton, NJ)
- …commercial leadership for pipeline products, partnering closely with Development, Medical, Regulatory , CMC , Commercial, and Project Leadership to optimize ... Join us and make a difference. **Position Summary** The Director , Commercial Development will serve as the leader accountable...as ID2, 3, and 4, representing key products to Executive Management. The leader must be able to operate… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …input into the Clinical Development Plan, and it requires collaboration with clinical, regulatory , medical, CMC and Global Insights. + **Global Brand Strategy & ... Sr Director , Global Launch Readiness - Immunology Date: May...& Cross-Functional Leadership** , including partnership with R&D, Medical, Regulatory , Global Insights & Analytics, and coordination with regions… more
- AbbVie (Irvine, CA)
- …Research Group at AbbVie seeks an accomplished scientist and leader. The Director /Senior Principal Research Scientist will lead a team performing in vivo ... productive, collaborative, and inclusive laboratory environment in compliance with regulatory and company expectations. Experience managing projects from early-stage… more
- AbbVie (Irvine, CA)
- …Research Group at AbbVie seeks an accomplished scientist and leader. The Director /Senior Principal Research Scientist will lead a team performing in vitro and ... productive, collaborative, and inclusive laboratory environment in compliance with regulatory and company expectations. Experience managing projects from early-stage… more
- Lilly (Cambridge, MA)
- …significant improvements in healthy outcomes for our customers. We are seeking an Executive /Senior Director - DDCS Drug Delivery and New Product Innovation to ... the Medicines Innovation Hub and the Business Units, as well as leaders in Regulatory and Manufacturing to define and deliver our strategy. This individual will be… more
- UTMB Health (Dallas, TX)
- …**_JOB SUMMARY_** **:** Works under the direction of the Associate Medical Director . **_ESSENTIAL JOB FUNCTIONS (Medical Director )_** **:** + Contributes to ... and recommends institutional policies and procedures that will enable UTMB CMC to maximize Digital Medical Services/Telemedicine. + Contributes to the development… more
