- Gilead Sciences, Inc. (Foster City, CA)
- …cancer and inflammation, and serious respiratory and cardiovascular conditions. **Director, CMC Regulatory Affairs - Biologics** **Key Responsibilities:** ... The Director, CMC Regulatory Affairs for Biologics is responsible for...Development & Manufacturing (PDM) Project teams. **Job Description:** + Lead CMC regulatory strategy for… more
- Merck (North Wales, PA)
- …Principal Scientist / Director responsibilities include but are not limited to:** + Serve as a Regulatory CMC Project Lead and provide CMC Regulatory ... Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of...Support new technology development. + Demonstrate an understanding of regulatory affairs and applies this understanding to… more
- Takeda Pharmaceuticals (Lexington, MA)
- …as a Director GRA CMC where you will independently develop and lead the execution of regulatory CMC investigational, registration and/or pos-approval ... for assigned products as GRA CMC Product Lead . Represents and contributes to Regulatory , Pharmaceutical...across a complex matrix environment in GRA with GRLs, CMC RA project leads and other GRA… 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, ... as new data become available. + Escalates issues to CMC Regulatory Affairs Management that...Authorities under supervision of a senior member of the CMC RA staff. + Strong knowledge of… more
- Lilly (Indianapolis, IN)
- …make life better for people around the world. We are seeking an Advisor/Senior Advisor for Global Regulatory Affairs CMC to be a part of the Lilly Global ... Trial Applications, Market Registrations And Post-Approval Submissions. The Research Scientist in Global Regulatory Affairs - CMC will leverage CMC … more
- Organon & Co. (Plymouth Meeting, PA)
- …in the Organon franchise teams. + Lead development and execution of regulatory CMC strategies to ensure high quality, accuracy, and high likelihood of ... with internal colleagues and Contract Research & Manufacturing Organizations to enable regulatory CMC strategies and execution of clinical study phase and… more
- BeiGene (San Mateo, CA)
- …projects. + Work collaboratively with cross-functional leads and communicate regulatory CMC strategies for assigned projects. + Lead regulatory risk ... The individual will provide support to cross-functional teams on regulatory CMC strategies. **Essential Functions of the... Lead or contribute to development of internal regulatory CMC guidance, SOPs, and work instructions.… more
- Organon & Co. (Plymouth Meeting, PA)
- …in the Organon franchise teams. + Lead development and execution of regulatory CMC strategies to ensure high quality, accuracy, and high likelihood of ... Reporting to the Director or Executive Director in Organon Regulatory CMC New Products, the Associate Principal...leadership, communication, interpersonal and negotiating skills. + Ability to lead a team of direct or matrixed colleagues to… more
- Merck (Columbus, OH)
- …Lead quality oversight of product validation, verification, and risk mitigation activities. Regulatory CMC Oversight + Lead the preparation and submission ... pivotal leadership role within the organization, overseeing the quality assurance and regulatory CMC for complex medical devices, including auto-injectors and… more
- Amgen (Washington, DC)
- …us and transform the lives of patients while transforming your career. ** Regulatory Affairs Director - Global Regulatory Lead ** **What you will do** ... organization. The role of the Regulatory Affairs Director is to: + Lead GRTs...filings (eg clinical trial applications, marketing applications, label extensions, CMC changes) + Ensure consistency of evidence-based global product… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Director, Regulatory Affairs (Early Development) provides strategic global regulatory ... requests, and briefing documents. + Acts as liaison between Regulatory Affairs and other functional areas, including...e-CTD compliance. + As required, serves as a global regulatory lead on a specific or assigned… more
- Actalent (Bridgewater, NJ)
- …as well as preside over the company's regulatory strategy. The position will lead the regulatory affairs and operations team and partner closely with ... Regulatory AffairsJob Description We are seeking a Head of Regulatory Affairs to be based in Bridgewater, NJ....will lead our regulatory submissions… more
- Amgen (Washington, DC)
- …(GRT) in the Regulatory Affairs organization. The purpose of Regulatory Affairs Director is: + To lead a team within Amgen's Global Regulatory ... time for a career you can be proud of. ** Regulatory Affairs Director - Global Regulatory...**Key Responsibilities include:** + Develop and execute the global regulatory product strategy + Lead Global … more
- Takeda Pharmaceuticals (Boston, MA)
- …to senior management to plan, evaluate and recommend implementation strategy. As part of the Regulatory Affairs CMC team, you will report to the Executive ... Director and Head, CMC Regulatory Affairs - Pharmaceuticals....in conjunction with direct reports, manages resources, establish a CMC RA strategy and collaborate with stakeholders… more
- Takeda Pharmaceuticals (Boston, MA)
- …Proactively recognizes and contributes to enhancing business processes. As part of the Global Regulatory Affairs CMC team, you will report to the Senior ... Director Global Regulatory Affairs CMC . **How you...Director Global Regulatory Affairs CMC . **How you will contribute:** +... CMC experience including experience as an RA CMC product lead with… more
- Danaher Corporation (Chicago, IL)
- …ideal operating environment to lay the groundwork for vital new discoveries worldwide. You will lead the Regulatory Affairs department and report to the Vice ... human health. This position is part of Quality and Regulatory Affairs located in Fargo, ND and...this role, you will have the opportunity to: + Lead regulatory submissions, including pre-market applications, product… more
- Vera Therapeutics (Brisbane, CA)
- …complete regulatory content that meets current regional requirements. * Represent Regulatory Affairs (Clinical and CMC ) on cross-functional project ... Job Title: Senior Manager, Regulatory CMC Location: Brisbane, CA About...field and 6+ years of relevant experience and demonstrated Regulatory Affairs experience commensurate with the role.… more
- AbbVie (South San Francisco, CA)
- …technologies to discover and develop novel cancer treatments. We are currently seeking a Regulatory Affairs Director to join our growing regulatory team. In ... this role you would be the Global Regulatory Lead where you will develop and...preferred. + 8 - 12 years of experience in Regulatory Affairs (strong preference for experience in… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …throughout the product's lifecycle and across different indications. Represent Global Regulatory Affairs on the GPT (Global Project Team), Daiichi ... global projects. + Interface with clinical and pre-clinical groups, Regulatory CMC and other appropriate groups within...pharmaceutical industry + 7 or More Years with direct regulatory affairs experience, including experience in … more
- Actalent (Boston, MA)
- …Masters, PharmD, or PhD preferred. + Minimum of 5+ years of relevant experience in CMC Regulatory Affairs for biologics, including IND activity, global CTAs, ... to Boston area to accommodate flexible hybrid schedule Responsibilities: + Actively represent Regulatory CMC and provide regulatory expertise as a member… more