- Vera Therapeutics (Brisbane, CA)
- …team. The Senior Manager will report to the Senior Director of Regulatory CMC and will be responsible for working with the cross-functional team ... Job Title: Senior Manager, Regulatory CMC Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on… more
- Takeda Pharmaceuticals (Boston, MA)
- …of the Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC . **How you will contribute:** + ... life-changing therapies to patients worldwide. Join Takeda as a Director , GRA CMC Small Molecules where you...where you will oversee the development and execution of regulatory CMC development and registration strategies. RA… more
- Merck (North Wales, PA)
- **Job Description** Under general supervision of an Executive Director / Senior Director , the Principal Scientist / Director is responsible for developing ... their assigned projects. **Position Description** **The Principal Scientist / Director responsibilities include but are not limited to:** +...but are not limited to:** + Serve as a Regulatory CMC Project Lead and provide … more
- Takeda Pharmaceuticals (Lexington, MA)
- …development plans. As part of the GRA CMC team, you will report to the Senior Director GRA CMC and work cross functionally across the business. **How you ... where you will independently develop and lead the execution of regulatory CMC investigational, registration and/or pos-approval strategies for assigned products… more
- J&J Family of Companies (Horsham, PA)
- Johnson & Johnson is recruiting for an Associate Director , CMC Regulatory Affairs. This position can be located in Spring House, PA; Horsham, PA; Titusville, ... and commercialization. This person is responsible for developing global CMC regulatory strategies. The primary responsibility is... senior member of the department. + Reviews CMC regulatory dossiers for global submissions throughout… more
- Lilly (Philadelphia, PA)
- …determined to make life better for people around the world. **Position Overview:** The Associate Director - CMC Regulatory is responsible for leading global ... CMC regulatory activities for Lilly/Avid diagnostic radiopharmaceutical products. This includes...effectively communicate the status of ongoing CMC regulatory projects to cross-functional teams and senior … more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Director , GRA CMC Pharmaceuticals Development Portfolio Lead where ... trade associations and acts as an advisor/ liaison to senior management to plan, evaluate and recommend implementation strategy....CMC team, you will report to the Executive Director and Head, CMC Regulatory … more
- AbbVie (North Chicago, IL)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director of CMC Product Development will use their ... CMC activities with respect to science, technology, quality, regulatory /compliance requirements, budget and resources. + Multiple product development experiences… more
- AbbVie (North Chicago, IL)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director of CMC Dossier Leadership will lead an ... team responsible for the creation and management of high-quality CMC submission strategies and Module 3 regulatory ...short-term and long-term plans to achieve goals set by senior management. Drive consensus for goals to meet the… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with 8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience or + PhD. with 6-8 years pharmaceutical industry ... experience and 4+ years direct or related CMC regulatory experience + Successful track record in preparation, management of review and approval of NDA/MAA/BLA… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical ... preferred - 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission experiences for oncology… more
- Lilly (Philadelphia, PA)
- …and cost targets. + Collaborate with cross-functional team leaders, including development, CMC regulatory , manufacturing, and supply chain teams, to ensure ... budget, and resource allocation, and provide regular updates to senior management. + Lead other tasks / projects as...projects and programs. + Advanced understanding of cGMPs and CMC regulatory requirements + Ability to manage… more
- Gilead Sciences, Inc. (Foster City, CA)
- …more than 35 countries worldwide, with headquarters in Foster City, California._ ** Senior Director - Analytical Regulatory ** **Science** **KEY** ... **RESPONSIBILITIES** The Sr Director , Analytical Regulatory Science, is responsible for supervising a team of...leading the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure… more
- Takeda Pharmaceuticals (Boston, MA)
- …to the best of my knowledge. **Job Description** Senior Technical Regulatory Advisor - Pharmaceuticals ( Senior /Executive Director ) OBJECTIVES/PURPOSE + ... a network of company Subject Matter Experts across Global R&D (Pharmaceutical Sciences, CMC Regulatory Affairs & Devices), Global Manufacturing Supply and Global… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** Reporting to the Director in Regulatory Chemistry, Manufacturing and Controls, the Senior Scientist is responsible for ... for the preparation and review of information required for development of regulatory CMC dossiers for commercial products including original registrations,… more
- Danaher Corporation (Chicago, IL)
- …Regulatory Affairs department and report to the Vice President of Global Quality and Regulatory Affairs. The Director of Global Regulatory Affairs will be ... human health. This position is part of Quality and Regulatory Affairs located in Fargo, ND and will be...the authoring, review and support of client filings including CMC submission in INDs, BLAs, NDAs, etc. + Primary… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and/or arbitrator on global projects. + Interface with clinical and pre-clinical groups, Regulatory CMC and other appropriate groups within the company as ... Oncology) is responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US, EU, Japan, China, and other… more
- Lilly (Indianapolis, IN)
- …drug product, process validation, process controls, compliance, continuous process optimization, CMC regulatory support, manufacturing data analysis and process ... data management. The Sr. Director - TS/MS enables operational excellence by establishing strong...to evaluate manufacturing process data. + Providing support to CMC / Regulatory teams through the preparation of required… more
- Ascendis Pharma (Palo Alto, CA)
- …and those of direct reports. + Work is performed under direction of a Senior Regulatory Affairs professional. + Contribute to internal regulatory policies ... dynamic workplace for employees to grow and develop their skills. The Associate Director , Regulatory Affairs will be responsible for developing and implementing… more
- Novo Nordisk (Lexington, MA)
- …the therapeutic area, help develop PRO and biomarker strategies. Relationships Reports to: Senior Director of the Novel Modalities department Work with the ... you ready to make a difference? The Position The Senior International Medical Director serves as a...Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be… more