- Catalent (PA)
- Account Director , Biologics Drug Substance Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative ... the Biologics industry with a focus on:US Market trendsUS Marketing and trade marketing practicesUS Regulatory knowledgeCompetitive selling strategiesWhy you… more
- Merck & Co. (Rahway, NJ)
- …world.Looking for someone with a growth mindset.Position Description: The Senior Director , Global Regulatory Lead, is responsible for development and implementation ... strategy/registration requirements for one or more company investigational and marketed drugs/ Biologics . Programs may be complex with more than one indication,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Collaborates with the PSL(s) to plan and prioritize activities for Biologics License Applications (BLAs)/ Marketing Authorization Applications (MAAs), and local ... with the PSL(s) to plan and prioritize activities for Biologics License Applications (BLAs)/ Marketing Authorisation Applications (MAAs), and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … biologics , Corporate Business Management)Partner and collaborate with global marketing , global medical affairs, global payers and access and commercial business ... for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science (CS) Group Lead will… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …within the Global Clinical Science function. This position may be at the executive director level or senior director level, depending on the scope and size ... (in particular CSPV, QA, and other functions as Pharm Tech SC and biologics , Corporate Business Management)- Partner and collaborate with global marketing ,… more
- Catalent Pharma Solutions (Morrisville, NC)
- **Account Director , Biologics Drug Substance** Catalent ...a focus on: + US Market trends + US Marketing and trade marketing practices + US ... facility in Madison, WI. This position has responsibility for establishing new biologics drug substance partnerships in the target territory. Success will be… more
- Amgen (Thousand Oaks, CA)
- …patients worldwide. It's time for a career you can be proud of. ** Director Process Development: Pivotal Biologics - Drug Product Technologies** **Live** **What ... change the world. In this vital role as a Director within the Pivotal Biologics group in...Technology transfer to commercial manufacturing and authoring of the marketing application and responses to agency questions. + Advancement… more
- Curia (Albany, NY)
- Manager/ Director , Business Development; Biologics Discovery - East Coast (Northeast/Mid Atlantic) Level dependent upon experience Curia provides global contract ... and manufacturing services to the pharmaceutical and biotechnology industries. The Manager/ Director , Business Development; Biologics Discovery Services is an… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …with a less traditional background. **Job Description** The Head of Sales, US Biologics will lead the US field-based biologics sales team by developing ... organizational goals. Key responsibilities include the implementation of all marketing initiatives, including contributing to brand equity development, annual brand… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …a less traditional background. **Job Description** We are seeking Healthcare Provider (HCP) Marketing Director , Rheumatology as a go-to subject matter expert on ... pipeline for rheumatology. The role will report into the Head of Marketing , US Biologics **Responsibilities:** + Gain and leverage insights and analysis of HCP… more
- Bristol Myers Squibb (Princeton, NJ)
- …lives. Read more: careers.bms.com/working-with-us . The CMC Regulatory Associate Director , Biologics is responsible for content development, compilation, ... and review of the Quality Module for regulatory submissions to support biologics products regarding: Clinical trial applications; New marketing applications; HA… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …a Lead for commercial analytics, with a strong background in forecasting, for our Biologics portfolio. As an analyst specializing in Biologics , you will be ... forecasting and commercial analytics in the pharmaceutical industry, preferably in the Biologics /Biosimilars space. He/she will be a key member of the Biologics… more
- Bristol Myers Squibb (Princeton, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . ** Director , Development DMPK** Challenging. Meaningful. Life-changing. Those aren't words ... DMPK plays a critical role in IND submissions and marketing authorization applications. We utilize our deep expertise in...across the globe. PCO is looking for a Scientific Director to join the Development DMPK group that is… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. **Summary** The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, ... topics. **Responsibilities** - Supports CMC regulatory compliance activities for portfolio biologics to meet US, International Conference on Harmonization (ICH), and… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …suspension in 2022. The company handles research, clinical development, sales, marketing , medical affairs, and business development functions. MTPA is dedicated to ... real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs (Early Development) provides strategic global regulatory guidance to… more
- Editas Medicine (Cambridge, MA)
- …the CMC strategies and submission including clinical trials applications, marketing applications, agency briefing packages and response to regulatory authority ... queries. The Director will incorporate regulatory strategy and well positioned content...with both US FDA and EMA with drugs and/or biologics is required. + Prior BLA, sBLA, NDA or… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Collaborates with the PSL(s) to plan and prioritize activities for Biologics License Applications (BLAs)/ Marketing Authorization Applications (MAAs), and local ... + Collaborates with the PSL(s) to plan and prioritize activities for Biologics License Applications (BLAs)/ Marketing Authorisation Applications (MAAs), and local… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …suspension in 2022. The company handles research, clinical development, sales, marketing , medical affairs, and business development functions. MTPA is dedicated to ... researching on real-world evidence, and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Clinical, may be called upon to guide a team… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director Regulatory Affairs CMC (Biologic Products) Date: Jun 13, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva ... and new people to make a difference with. **The opportunity** The Sr. Director , Global Regulatory Affairs CMC is responsible to oversee and help develop regulatory… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …suspension in 2022. The company handles research, clinical development, sales, marketing , medical affairs, and business development functions. MTPA is dedicated to ... As a senior member of Medical Science, the Senior Director , Medical Science - Early Stage will lead the...meet overall corporate objectives leading to submission for world-wide marketing applications. Therapeutic areas may vary, and the pipeline… more
