- BioAgilytix (Durham, NC)
- …while you enable life-changing, life-saving therapeutics to the patients who need them.The Regulatory Affairs Manager is responsible for coordinating the ... and life cycle management. This includes development and implementation of regulatory strategies and timelines as well as the preparation of submissions.Essential… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Director, Regulatory Affairs Liaison, is responsible for development and implementation of global regulatory strategy for their assigned ... Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Develops… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a Project Manager within the Strategy Realization Office (SRO) function of GMSA at our company, the successful applicant will play a critical role ... in leading major global initiatives aimed at enhancing Medical Affairs practices. The SRO is a recognized internal management consulting team within Medical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and will work regularly with all business areas (Sales, Marketing, Clinical, TMPC, Med Affairs , and Regulatory Affairs ) and support functions (IT, Finance, ... scheduling, video production, set creation, casting, costume and various pre -production preparatory work).Analytics ReportingDevelop, create and track reporting metrics… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …including but not limited investor relations, RD, global and US medical affairs and marketing, legal, regulatory and congress planning Qualifications: Successful ... - Support planning and managing the development and execution of pre -launch, launch and post-launch corporate communications strategies and programs for specific… more
- FISI - FUJIFILM Irvine Scientific (Santa Ana, CA)
- Overview We are hiring a Clinical Affairs Program Manager . The Clinical Affairs Program Manager will be responsible for the development and generation of ... and evaluation and review of clinical data, generated both pre and post-market for medical devices and in vitro...and in vitro diagnostic devices. In addition, the Clinical Affairs Program Manager will perform annual activities… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Manager , Regulatory Affairs (Remote)...as a result of an agency referral where no pre -existing agreement is in place. Where agency agreements are ... new people to make a difference with. **The opportunity** As the Senior Manager , Regulatory Affairs you will be responsible for indirectly supporting the… more
- Philips (Orlando, FL)
- The Senior Manager Regulatory Affairs will play a critical role within Philips' Clinical Informatics organization by leading regulatory projects for ... patients around the world. **Your role:** + Leading project teams for end-to-end regulatory affairs input and deliverables for new product introductions and… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- **Job Description Summary** As Manager , Regulatory Affairs , you will provide leadership to the MMS -Pharmacy Automation platform team. You will contribute to ... pre -market regulatory leadership to MMS-PA business + Directs premarket regulatory affairs activities which may include interactions between MMS-PA and… more
- Teva Pharmaceuticals (West Chester, PA)
- Manager , CMC Regulatory Affairs -...as a result of an agency referral where no pre -existing agreement is in place. Where agency agreements are in ... people 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… more
- J&J Family of Companies (Irvine, CA)
- Manager , Regulatory Affairs - Biosense Webster, Inc. - 2406185650W **Description** Biosense Webster, part of the Johnson & Johnson MedTech family, is ... currently recruiting for a ** Manager , Regulatory Affairs ** . _This...Conduct submission negotiations with the FDA as needed, including pre -submission identification of requirements and strategy and post submission… more
- AbbVie (Chicago, IL)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Manager , Regulatory Affairs In Vitro Diagnostics and Companion ... implements, and documents policies and procedures within the regulatory affairs department under supervision of manager . Participates in initiatives internal… more
- Philips (San Diego, CA)
- **Senior Regulatory Affairs Manager (US Hub based location)** The Senior Regulatory Affairs Manager will develop and communicate a vision for the ... of regulatory submissions. You will manage a Regulatory Affairs team supporting various new and...requirements are determined to go into effect._ + _Providing regulatory support for ( pre -) clinical studies, including… more
- Astrix Technology (Houston, TX)
- Global Regulatory Affairs Manager II Regulatory Affairs Houston, TX, US Pay Rate Low: 65.00 | Pay Rate High: 75.72 + Added - 08/03/2024 Apply for Job ... in the world - with complementary businesses in Surgical and Vision Care. **Global Regulatory Affairs Manager II** 55.00-72.75 9 Month Contract with… more
- Novo Nordisk (Plainsboro, NJ)
- …Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop and maintain positive ... rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and...pre -BLA) for review by Project Leaders + Write Regulatory documents translating team strategy into regulatory … more
- University of Pennsylvania (Philadelphia, PA)
- …duties relevant to regulatory affairs as assigned. DUTIES: Reporting to the Regulatory Affairs Manager , the Regulatory Affairs Specialist ... coordination of Phase I-V clinical trials. Reporting to the Regulatory Affairs Research Teams Manager ,...for eligible health care and dependent care expenses with pre -tax dollars. + Tuition : Take advantage of Penn's… more
- GE Vernova (Wilmington, NC)
- …working groups. Occasional travel is required. The role is in Regulatory Affairs and reports to the General Manager of Nuclear Programs. **Job Description** ... **Job Description Summary** The New Plant/Product (NPP) Licensing Manager will establish the vision & strategy and...establish the vision & strategy and drive execution for Regulatory Affairs to accelerate the licensing needed… more
- System One (Florham Park, NJ)
- Title: Manager /Senior Manager US Regulatory Affairs - Global Development Projects Location: Remote Type: Contract Rate: 52-70 (DOE) Start Date: ASAP ... located in NJ is hiring a Manager /Senior Manager US Regulatory Affairs -...strategies for multiple clinical development projects at all stages ( Pre -IND through NDA submission and approval). + Support and… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …evidence, and creating hope for all facing illness. The Senior Director, Commercial Regulatory Affairs , is responsible for the development and execution of the ... US and Canada. In addition, the Senior Director, Commercial Regulatory Affairs , in collaboration with Head, ...interactions with US FDA, OPDP and Health Canada for regulatory related activities by drafting pre -meeting briefing… more
- Bausch Health (Bothell, WA)
- …care options to consumers and physicians alike. Reporting to the Sr. Director, Global Regulatory Affairs , the Senior Manager , Regulatory Affairs ... regulatory agencies through oral and written communications regarding pre -submissions strategies, potential regulatory pathways, compliance test requirements,… more
