- Gilead Sciences, Inc. (Foster City, CA)
- …countries worldwide, with headquarters in Foster City, California. **About the Role:** The Senior Director , CMC Regulatory Affairs for Biologics is ... product in Gilead's global portfolio of biological products in CMC Regulatory Affairs . This position...by maintaining the global licensures. In addition, the Sr Director will be accountable for leading the interpretation and… more
- Amicus Therapeutics (Marlow, OK)
- Director , CMC RA Location Marlow,...matter experts in Tech Ops, Science, Quality and Global Regulatory Affairs to ensure timely delivery of ... # of openings 1 Apply Now (https://phh.tbe.taleo.net/phh04/ats/careers/v2/applyRequisition?org=AMICUS&cws=37&rid=1315) Job Brief Director , CMC RA Amicus Therapeutics… more
- Takeda Pharmaceuticals (Boston, MA)
- … CMC team, you will report to the Senior Director Global Regulatory Affairs CMC . **How you will contribute:** + Independently plan, execute and ... life-changing therapies to patients worldwide. Join Takeda as a Director , GRA CMC Small Molecules where you...oversee the development and execution of regulatory CMC development and registration strategies. RA … more
- Takeda Pharmaceuticals (Boston, MA)
- … CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. **How you will contribute:** + Leads the ... CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives....in conjunction with direct reports, manages resources, establish a CMC RA strategy and collaborate with stakeholders… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …to build/maintain database to address external questions regarding drug products. The CMC Regulatory Associate Director , Biologics is responsible for ... a products lifecycle. Members of the organization develop global regulatory CMC strategies and partners with key...HA meetings); and/or post-approval submissions. In this role, the GRS- CMC Associate Director , Biologics will serve as… more
- Takeda Pharmaceuticals (Lexington, MA)
- …life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Regulatory Affairs CMC where you will develop and lead the ... and/or post-approval strategies for assigned products. RA CMC member on the Global Regulatory ...CMC team, you will report to a Senior Director and work with stakeholders across the business. **How… more
- Lundbeck (Deerfield, IL)
- Director Global Regulatory Affairs CMC - Remote Opportunity Requisition ID: 5582 Location: Deerfield, Illinois, US Do you want to join a team where the ... of the product (IND/CTAs, NDAs/BLAs, Marketing applications). This role will provide CMC regulatory support and guidance for assigned projects and interfaces… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …including working with contract manufacturing organizations CMO.** This position serves as the Regulatory Affairs ( RA ) CMC project representative to ... higher-level manager. + ** Regulatory Knowledge:** Demonstrates expert knowledge of US/EU regulatory guidances. Serves as RA CMC representative supporting… more
- Boehringer Ingelheim (Ridgefield, CT)
- …and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Regulatory Affairs ( RA ) Fellowship within the Chemistry, Manufacturing ... areas covering multiple dosage forms while interacting effectively within Regulatory Affairs and across CMC ...resolution of comments from FDA with assistance from the Director /delegate CMC RA as needed.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ Works with CMC RA Team Leads to provide one CMC RA voice to PDM project teams regarding regulatory strategy and technical and quality risks. + ... for the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure... CMC control strategies and quality compliance to CMC RA and PDM leadership. + Develops… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Clinical (Neuroderm), may be called ... to facilitate timely drug development and registration. The Senior Director , Regulatory Affairs - Clinical...support marketing product claims. + Acts as liaison between Regulatory Affairs & CMC and… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs (Early Development) provides strategic global ... in the rare disease space. In this role, the Director defines and implements regulatory strategies; works...requests, and briefing documents. + Acts as liaison between Regulatory Affairs and other functional areas, including… more
- Ascendis Pharma (Palo Alto, CA)
- …a dynamic workplace for employees to grow and develop their skills. The Associate Director , Regulatory Affairs will be responsible for developing and ... implementing global regulatory strategies encompassing clinical, non-clinical and CMC ...complex and require extensive interaction with departments outside of regulatory affairs . + Excellent organizational skills and… more
- Danaher Corporation (Raleigh, NC)
- … Affairs department and report to the Vice President of Global Quality and Regulatory Affairs . The Director of Global Regulatory Affairs ... human health. This position is part of Quality and Regulatory Affairs located in Fargo, ND and...the authoring, review and support of client filings including CMC submission in INDs, BLAs, NDAs, etc. + Primary… more
- Ascendis Pharma (Palo Alto, CA)
- …all aspects of the business, from drug development to marketing. The Senior Manager, Regulatory Affairs will be responsible for supporting and developing global ... Alto, CA and reports directly to the Head of Regulatory Affairs . Key Responsibilities + Responsible for.... Key Responsibilities + Responsible for strategic and operational regulatory input and support for cross functional ( CMC… more
- AbbVie (North Chicago, IL)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director Regulatory Affairs Therapeutic Area Head, GRS, is ... responsible for the management of global regulatory leads with product and disease state expertise for...may develop and implement policies and procedures within the RA department and ensures direct reports follow requirements. Ensures… more
- Gilead Sciences, Inc. (Foster City, CA)
- …regulations to ensure approvability globally. The incumbent will report directly to Head of CMC Regulatory Affairs - Systems and Operations at Gilead. **JOB ... countries worldwide, with headquarters in Foster City, California._ **Senior Director - Analytical Regulatory Science** KEY RESPONSIBILITIES... Team Leads to provide one CMC RA voice to PDM project teams regarding regulatory… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio ... be responsible for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data,… more
- Lilly (Indianapolis, IN)
- …for people around the world. Purpose: The purpose of the Senior Director /Executive Director , Global Regulatory Affairs , Global Regulatory Lead (GRL) ... regulatory excellence attributes as described in Global Regulatory Affairs white papers. + Participatein forumsthatshareregulatoryinformationacrossGRA… more
- Gilead Sciences, Inc. (Foster City, CA)
- …with Small Molecule Drug Substance Development, Small Molecule Drug Product Development, CMC Regulatory Affairs , Quality Control and Manufacturing Operations ... Join Gilead and help create possible, together. **Job Description** ** Director , Small Molecule Analytical Development, Analytical Development and Operations (ADO)**… more