- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ensuring appropriateness throughout the product's lifecycle and across different indications. Represent Global Regulatory Affairs on the GPT ( Global ... responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the...in the pharmaceutical industry7 or More Years with direct regulatory affairs experience, including experience in … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for bringing the issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned US RA strategist on the assets. This ... coordinating, mentoring, and providing guidance to direct reports (US RA strategists) across the alliance products to produce robust,...or working or resources to the Head of US Regulatory Affairs and/or Global … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs ( RA ) CMC project representative to the CMC ... support of global submissions and this position serves as the RA CMC representative supporting company initiatives (liaison with PhRMA, USP, ICH, due diligence,… more
- Merck & Co. (Rahway, NJ)
- …placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director may be responsible for:Evaluating pre-clinical and ... with talented and dedicated colleagues while developing and expanding your career.The Senior Director (Sr. Principal Scientist) has primary responsibility for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technologies/ Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of ... at key governance meetings whereby GCLP/GLP activities are being discussed ( Regulatory affairs , Research unit LT, GRDC etc.,) Effectively interacts… more
- Merck & Co. (Rahway, NJ)
- …studies;Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Director may be… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …ensuring appropriateness throughout the product's lifecycle and across different indications. Represent Global Regulatory Affairs on the GPT ( Global ... responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the...pharmaceutical industry + 7 or More Years with direct regulatory affairs experience, including experience in … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …for bringing the issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned US RA strategist on the assets. This ... coordinating, mentoring, and providing guidance to direct reports (US RA strategists) across the alliance products to produce robust,...or working or resources to the Head of US Regulatory Affairs and/or Global … more
- AbbVie (Florham Park, NJ)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs , Strategic Labeling is responsible for ... strategy and product labeling (CCDS, US/EU labeling documents) at Senior level meetings ( Global Regulatory ...+ Preferred Education: Relevant Master's degree preferred. Certification in regulatory affairs a plus + Required Experience:… 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 the CMC ... support of global submissions and this position serves as the RA CMC representative supporting company initiatives (liaison with PhRMA, USP, ICH, due diligence,… more
- System One (Florham Park, NJ)
- Senior Manager, Regulatory Affairs ...Life (QOL), plays a pivotal role in supporting the Senior Director in overseeing regulatory ... days onsite) 12-month contract (renewable) Overview The Contractor - Senior Manager, Regulatory Affairs -...QOL initiatives. Responsibilities + Support the Senior Director in developing and executing regional regulatory … more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** Reporting to the Director in Regulatory Chemistry, Manufacturing and Controls, the Senior Scientist is responsible for ... products in accordance with global regulations, guidance's and defined regulatory strategies. The Senior Scientist is responsible for the preparation… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Senior Director , Patent Attorney (Parsippany, NJ) Date: Nov 4, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: ... people to make a difference with. **The opportunity** As ** Senior Director , Patent Attorney** , you'll lead...positions + Determine ANDA submission strategy, in collaboration with regulatory affairs + Support the IP litigation… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Senior Director , Associate General Counsel, Transactions Date: Nov 9, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals ... their interdependent functions, including R&D, intellectual property, supply chain, finance, and regulatory affairs . This role will also help oversee internal… more
- Merck (Rahway, NJ)
- **Job Description** Under general supervision of an Executive Director / Senior Director , the Principal Scientist / Director is responsible for developing ... for projects of increasing complexity. + Lead development and execution of detailed, global regulatory submissions of INDs, BLAs or post approval change… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Implementing strategic and tactical plans to drive sustainable improvements. + Supports Regulatory Affairs in providing quality content and review of documents ... at key governance meetings whereby GCLP/GLP activities are being discussed ( Regulatory affairs , Research unit LT, GRDC etc.,) Effectively interacts… more
- JPMorgan Chase (New York, NY)
- …years' experience at a large financial institution, regulator or law firm leading regulatory affairs and/or engagements. + BA/BS or similar degree required. + ... status quo and striving to be best-in-class. As the Regulatory Strategy Director "RSD" for Asset &...team and for providing strategic advice and direction to senior LOB/function leaders concerning regulatory matters. This… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …and guide product strategy -- May include cross-functional collaboration with R&D, Medical Affairs , Market Access, Regulatory Affairs and Marketing + ... **Job Description Summary** The HEOR Associate Director - BU based is accountable for ensuring...BD while informing the broader scientific strategy with Medical Affairs . This role is accountable for de-risking the new… more
- Merck (Rahway, NJ)
- …monitoring, analysis, regulatory reporting, and publication. **Specifically, The Senior Director May Be Responsible For** + Evaluating pre-clinical ... talented and dedicated colleagues while developing and expanding your career. The Senior Director ( Senior Principal Scientist) has primary responsibility… more
- Merck (Rahway, NJ)
- …position operates under the guidance of the Associate Director who supports the Global Regulatory Affairs & Clinical Safety (GRACS) and Quality Assurance ... + Provide financial planning, forecasting and analytical support to ourResearch&DevelopmentDivision, Global Regulatory Affairs & Clinical Safety (GRACS),… more
