- Tris Pharma (Monmouth Junction, NJ)
- …This includes, but is not limited to: Research, Product Development, Clinical Development, Regulatory Affairs , CMC , New Products, Sales & Marketing, and ... evaluation; provide input on deal terms and creation of relevant clinical, regulatory , and commercial scenarios Prepare clear and concise presentations across a… more
- Aequor (NJ)
- …Global Study Management and Monitoring (GSMM), Project Management, Client Affiliates, Medical Affairs (MA), Regulatory , CMC , QA, Packaging Vendors, CRO's, ... studies during phases 1-4. The individual must partner closely with clinical, regulatory , quality and production associates to ensure timely delivery of supplies to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to biologics and Oncology, incl. coordinating Reg Intelligence & Policy activities with the Regulatory - CMC function and corporate affairs as needed. In the ... working. This role will also work with the Global Regulatory Affairs Leadership Team (GRA-LT) to define...with DS' strategic objectivesWork with other DS functions (incl. Regulatory - CMC ) to coordinate Regulatory Intelligence… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …personnel in other departments including Marketing, CMR, Legal, and counterparts in NNAS Regulatory Affairs . Has a positive approach to work projects and ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...tasks and assignments Participates in department forum meetings eg CMC , PRB, and ensures that proper minutes from these… 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 ... be responsible for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, ... this role will need to partner closely with teams and senior leaders from across Regulatory Affairs , as well as cross-functional stakeholders (eg, RA CMC ,… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director Regulatory Affairs CMC (Biologic Products) Date: May 15, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva ... people to make a difference with. **The opportunity** The Sr. Director, Global Regulatory Affairs CMC is responsible to oversee and help develop … more
- Lilly (Indianapolis, IN)
- …determined to make life better for people around the world. **Senior Advisor/Director, Global Regulatory Affairs - CMC , Small Molecules** At Eli Lilly, we ... patients who need them all over the world. The Senior Advisor/Director in Global Regulatory Affairs - CMC Small Molecules will leverage CMC technical… more
- Danaher Corporation (Marlborough, MA)
- …technical expertise and talent to develop the next generation of life-changing therapeutics. The Regulatory Affairs CMC Officer for Cytiva is responsible for ... with regulatory authorities on CMC matters. + Leads cGMP CMC regulatory intelligence activities, including proactive communication of regulatory … more
- Taiho Oncology (Pleasanton, CA)
- Director, Regulatory Affairs CMC Pleasanton, CA, USA Req #355 Tuesday, March 26, 2024 Looking for a chance to make a meaningful difference in the oncology ... our dynamic and expanding mid-size oncology company in the role of Director , Regulatory CMC , reporting directly to Executive Director, Regulatory CMC .… more
- Lilly (Indianapolis, IN)
- …for market registrations and post-approval submissions. The regulatory scientist in Global Regulatory Affairs - CMC Biotechnology will leverage CMC ... technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for marketing authorizations for the… more
- Takeda Pharmaceuticals (Lexington, MA)
- …**Job Description** Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC Submissions Management in Lexington, MA with ... changing requirements and priorities; develop/maintain strong working relationships with the regulatory CMC team and cross-functional teams, participate on… more
- Takeda Pharmaceuticals (Boston, MA)
- …**Job Description** Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC in Cambridge, MA with the following ... requirements: Master's degree in Regulatory Affairs or related field plus 2 years of related experience. Prior experience must include: Develop the regulatory… more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as a Director, Regulatory Affairs Vaccines CMC where you will provide program ... regulations and guidelines by applying interpersonal skills and expert Regulatory Affairs Vaccines (RAV) CMC knowledge to identify, communicate, address,… more
- Amgen (New Albany, OH)
- …patients worldwide. Become the professional you are meant to be in this meaningful role. Regulatory Affairs Manager, CMC . **Live** **What you will do** Let's ... all use our unique contributions to serve patients. The Regulatory Affairs professional we seek is a...manufacturing and quality programs throughout product lifecycle. + Provide CMC regulatory strategy for products manufactured at… more
- Gilead Sciences, Inc. (Foster City, CA)
- …35 countries worldwide, with headquarters in Foster City, California. **Sr Director, CMC Regulatory Affairs -Small Molecules** **KEY RESPONSIBILITIES** The ... Sr Director, CMC Regulatory Affairs for Small Molecules is responsible for managing a team of professionals, who work with Gilead's global portfolio of small… more
- Teva Pharmaceuticals (West Chester, PA)
- Manager, CMC Regulatory Affairs - Remote OR West Chester, PA Date: May 15, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva ... to make a difference with. **How you'll spend your day** As Manager, CMC Regulatory Affairs you will be responsible for managing the day-to-day chemistry,… more
- CSL Behring (King Of Prussia, PA)
- …business objectives and current health authority expectations. o Provides communications between Global Regulatory Affairs CMC and partners within GRA and ... you be our next CSL Plasma Lead for Global Regulatory Affairs , Plasma? This position is located...Health Authorities, Industry Associations) and company partners to shape regulatory CMC requirements. You will lead and… more
- Editas Medicine (Cambridge, MA)
- …years' experience in drug development/ regulatory affairs and a minimum 8 years in CMC regulatory affairs . + Experience with both US FDA and EMA with ... will be responsible for: + Provide CMC expertise in the Editas regulatory affairs organization by keeping abreast of global CMC regulatory … more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …the Senior Director, Commercial Regulatory Affairs , in collaboration with Head, Regulatory Affairs and CMC -RA, will review and assess all commercial ... creating hope for all facing illness. The Senior Director, Commercial Regulatory Affairs , is responsible for the development and execution of the post-approval… more
Related Job Searches:
Affairs,
Associate Regulatory Affairs CMC,
CMC,
CMC Regulatory,
Director Regulatory Affairs CMC,
Global Regulatory Affairs CMC,
Manager Regulatory Affairs CMC,
Regulatory,
Regulatory Affairs,
Regulatory Affairs Specialist CMC