- Merck (Rahway, NJ)
- **Job Description** **Principal Scientist / Director , GLOBAL REGULATORY CMC Biologics (R5)** Under general supervision of an Executive Director / Senior ... 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
- 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
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …**In this role, a typical day might include the following:** + Lead CMC /CP product development activities from a regulatory standpoint during early phase, ... market applications, and post market requirements with input from senior management. + Represent CMC /CP RA at...CMC /CP RA at program meetings and independently provide regulatory interpretation, position, and strategy for global CMC… 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
- 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
- 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 ... plans to facilitate timely drug development and registration. The Senior Director , Regulatory Affairs -...support marketing product claims. + Acts as liaison between Regulatory Affairs & CMC and other functional… 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
- Teva Pharmaceuticals (Parsippany, NJ)
- …and other global regulatory filings. **How you'll spend your day** The Senior Director : + Will foster relationships with opinion leaders in assigned ... Senior Director Clinical Development - Respiratory...working closely with other functional areas such as commercial, regulatory , pharmacovigilance, CMC , early clinical, and pre-clinical… more
- AbbVie (Florham Park, NJ)
- …Follow @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 specific therapeutic area(s). Provides oversight for the… more
- Bristol Myers Squibb (Summit, NJ)
- …better place than here at BMS with our Cell Therapy team. The ** Senior Director , Cell Therapy Manufacturing Technology** leads a cross-functional team ... will work closely with the global Manufacturing Science &Technology leadership and CMC functions to standardize CTO practices and ensure that the process remains… more
- Merck (Rahway, NJ)
- …multidisciplinary team environment with key stakeholders across organizations such as Regulatory CMC , formulation functions, and clinical functions to ensure ... have solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations, Non-clinical, Clinical, and… more
- Merck (Rahway, NJ)
- …integrating strategic and tactical input from diverse disciplines (eg, clinical, regulatory , market access, manufacturing, CMC , commercial, and other areas) ... & Division organization of our company. **Position Description/Summary:** The GPAM Associate Director , Project Manager, is a core member of Early Drug Development… more
- Bristol Myers Squibb (Summit, NJ)
- …Summary:** Bristol-Myers Squibb is seeking a Product Quality Leader (PQL), Associate Director of Global Product Quality to support early development projects within ... stage development programs (vector, gene editing and cell therapy projects) to ensure regulatory compliance of GMP operations in support of the program. The PQL must… more