- 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
- 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
- Merck & Co. (Rahway, NJ)
- …partnership with GCTO (Global Clinical Trial Operations) country operations, finance, regulatory affairs , pharmacovigilance, legal and regional operations, HQ ... Job DescriptionWith support of Sr CRA/CRA Clinical Research Associate) and/or CRA Manager , acts as primary site contact and site manager throughout all phases of… more
- Merck & Co. (Rahway, NJ)
- …with GCTO (Global Clinical Trial Operations) country operations, finance, regulatory affairs ,-pharmacovigilance, legal and regional operations, HQ functional ... Job DescriptionWith support of Sr CRA (Clinical Research Associate) and/or CRA Manager , acts as primary site contact and site manager -throughout all phases of a… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …teams, including sales, marketing, medical affairs , Centers of Excellence (COEs), regulatory affairs , and other relevant NNI departments to ensure alignment ... Are you ready to experiment with us? The Position The Consumer Strategist Manager will be a critical driver in shaping an insights-driven Consumer marketing… more
- Fidelity TalentSource LLC (Boston, MA)
- Job Description:The RoleAs a Senior Communications Manager for Fidelity Wealth, you will work directly for the Head Fidelity Wealth Communications supporting the ... standards in the areas of accuracy, ethics, legal, and complianceWorking across Corporate Affairs and with business partners (eg, HR, Strategy & Finance, Product &… more
- Philips (Bothell, WA)
- 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
- Novo Nordisk (Lexington, MA)
- …documents to regulatory agencies. Relationships Report to a Director of Regulatory Affairs . Develop and maintain positive rapport and working relationships ... with other personnel in Regulatory Affairs and other local and headquarter...Write Regulatory documents translating team strategy into regulatory overview documents such as cover letters, pre… 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
- 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
- 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
- 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
- Bausch Health (Bothell, WA)
- …proven and effective aesthetic care options to consumers and physicians alike. The Manager , Regulatory Affairs provides direct support to Solta operations ... related field. + Should have over 7 years of experience as Sr. Regulatory Affairs Specialist. + Should have experience of independently authoring complete… more
