- Merck & Co. (Rahway, NJ)
- …and dedicated colleagues while developing and expanding your career.The Executive Director , Chemistry, Manufacturing & Controls ( CMC ) , Pre-approval Pharm ... in executive forums, driving the development and implementation of CMC regulatory strategy and plans for assigned projects/products. Effectively communicates… more
- Merck & Co. (Rahway, NJ)
- …chain strategic elements through senior stakeholder management and appropriate executive governance forums. Develop and maintain product supply chain lifecycle ... Knowledge of business functions including Technology, Manufacturing Operations, Finance, Regulatory , Quality, Compliance, Supply Chain and Commercial. Understanding of… more
- Merck (Rahway, NJ)
- …career. The Executive Director , Chemistry, Manufacturing & Controls ( CMC ), Pre-approval Pharm will bring scientific and regulatory expertise, innovative ... member in executive forums, driving the development and implementation of CMC regulatory strategy and plans for assigned projects/products. + Effectively… more
- Lilly (Philadelphia, PA)
- …and advance care for patients with unmet needs. **Position Overview:** The Associate Director , CMC Development will be responsible for the execution of multiple ... Process Development, Analytical Sciences, Manufacturing, Quality, Supply Chain, R&D, Finance, and Regulatory to ensure delivery of CMC milestones for priority… more
- Orchard Therapeutics (Boston, MA)
- Location: Boston, MA Main responsibilities The Executive Director (ED) Regulatory Science will actively support, and serve as senior advisor to, the program ... collaborate with the assigned US Regulatory lead, their peers in Europe, the Regulatory CMC team and the VP of Regulatory Science, to ensure a consistent… more
- Lilly (Indianapolis, IN)
- …global regulatory climate and emerging requirements; ability to address key CMC regulatory questions that enable clinical studies and support marketing ... concept) to product commercialization + Experience in development / CMC including quality and regulatory interactions is...in development / CMC including quality and regulatory interactions is expected + Experience with technical transfer… more
- Lilly (Indianapolis, IN)
- …drug development experience for 10 years + Direct experience in clinical and CMC regulatory sciences + Experience in applicable therapeutic area + Knowledge ... around the world. **Purpose:** The purpose of the Senior Director , Global Regulatory Affairs, Global Regulatory...affiliate requirements. The GRL builds and leads the Global Regulatory Team (inclusive of GRA central functions, GRA- CMC… more
- Lilly (Indianapolis, IN)
- …regulatoryaffairsand/ordrugdevelopmentexperiencefor 10years + Direct experience in clinical and CMC regulatory sciences + Experience in applicable ... around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory...affiliate requirements. The GRL creates and leads the Global Regulatory Team (inclusive of GRA central functions, GRA- CMC… more
- Gilead Sciences, Inc. (Foster City, CA)
- …than 35 countries worldwide, with headquarters in Foster City, California. ** Executive Director , Global Clinical Supply Chain (GCSC)** **KEY RESPONSIBILITIES:** ... Executive Director , Global Clinical Supply Chain is responsible for leading...clinical labeling, distribution including cold chain, import/export, reverse logistics, CMC and GXP regulations. + Prior experience in complex… more
- Boehringer Ingelheim (Ridgefield, CT)
- …We are seeking a seasoned legal professional to join our Legal Department as Executive Director & Executive Counsel - Intellectual Property. This role ... provides strategic legal counsel to senior leadership (VP, EVP, CMC , and Level 1 executives), with a focus on intellectual property (IP) acquisition, due diligence,… more
- CSL Behring (King Of Prussia, PA)
- …position and is onsite three days a week. You will report to the Executive Director Head Regulatory . **Position Description** **Summary** * Regulatory ... connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC . *Applies the CSL Leadership Capabilities - Build Bridges,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …& Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Clinical Development and Technical Development to ... Description:** **We are seeking a talented and highly motivated Director for our Structural Characterization team in Biologics Pivotal...deliverables. + Serve as an author and reviewer of CMC sections in regulatory filings, and support… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …a demonstrated ability to work effectively with CDMOs. The position reports to Executive Director , CMC & Product Development. **Job Description** ... Director , Formulation Development is an experienced leader in...external functional representatives (CMOs, Manufacturing, Supply Chain, Quality Assurance, Regulatory , etc.) to deliver products that are commercially viable… more
- Gilead Sciences, Inc. (Foster City, CA)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** ** Executive Director , Formulation and Process Development** + The ... Executive Director of Formulation and Process Development will be responsible...collaborations with Gilead PDM functions such as Quality Assurance, CMC Reg, Manufacturing and Technical Operations, Product and Portfolio… more
- Merck (West Point, PA)
- …inform process development and release and characterize drug substance and drug product. The Director reports to the Executive Director , Cell Based Sciences ... BLAs.- The successful candidate will be responsible for strategic partnering with CMC development, Regulatory , Quality, and our partners in commercialization and… more
- ThermoFisher Scientific (Greenville, NC)
- …of ICH and other global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC , publishing, etc. + ... Clinical Trials in a CRO setting in an Oversight Director /Portfolio Lead Role** + **RFP/Bid Defense Experience** **(You MUST...a Therapeutic Unit. + Serves as senior level or executive contact. + May review financial forecasting of TA.… more
- Bill and Melinda Gates Foundation (Seattle, WA)
- …a candidate, please apply : https://www.sri- executive .com/opportunities/deputy- director -global-health-integrated-development-expertise-ghide-domain/ Your Role As ... four core domains: Global Health Integrated Development Expertise (GHIDE), Regulatory Affairs, Decision, Analyze, Communicate (DAC), and Chemistry, Manufacturing &… more
- Gilead Sciences, Inc. (Foster City, CA)
- …**Lead** **(Early Phase)** **_Location: Foster City_** **KEY RESPONSIBILITIES** Reporting to the Executive Director of Product & Project Management and operating ... within the broader Pharmaceutical Development and Manufacturing (PDM) organization, the **Senior Director , Product Management Team Lead** will lead a team of product… more
- CSL Behring (King Of Prussia, PA)
- …position and is onsite three days a week. You will report to the Executive Director Head Regulatory . **Position Description** **Summary** ** Regulatory ... connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC .** **As assigned, supports development of CSL policy positions… more
- BeOne Medicines (San Mateo, CA)
- …Clinical Development, Clinical Operations, Global Statistics & Data Science, Safety, Regulatory , CMC , Portfolio). + Hands-on experience with modern data ... As Director of R&D Data Enablement / Data Products,...chain. By collaborating with stakeholders across Research, Clinical, Safety, Regulatory , Portfolio & Project Management and other R&D functions,… more
