- Insmed Incorporated (NJ)
- …for the future of science, we're in. Are you?About the Role:We're looking for a Manager , Regulatory Affairs , Tactical Implementation, on the Regulatory ... possible for patients with serious diseases. Reporting to the Associate Director, Regulatory Affairs , Tactical Implementation, you'll have a critical role in… more
- ICON Clinical Research (Raleigh, NC)
- …join us on our mission to shape the future of clinical development. Sr Manager , Regulatory Affairs - IVD Location: US Remote, Portland, OR area preferred ... Senior Manager , Regulatory Affairs -... regulatory affairs , including development of regulatory strategies, document writing, marketing authorization applications, clinical… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …changed local market authorization holders and distributors. Primary Responsibilities: Act as Regulatory Affairs authority for key product registrations with a ... in more than 110 countries and regions. Summary: Implement worldwide regulatory product registration strategies, prepare complex registration dossiers, establish and… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, quality ... Position Summary Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug… more
- CSL Behring (Waltham, MA)
- Position Title: Senior Manager , Corporate & External Affairs , R&D Portfolio Position Purpose: The Senior Manager , Corporate and External Affairs , R&D ... Portfolio will execute the corporate and external affairs strategy for CSL's pipeline. The successful candidate will be responsible for executing communications for… more
- Globus Medical, Inc. (Audubon, PA)
- …to FDA Obtaining and reviewing clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as needed for IDE and PMA ... can resume their lives as quickly as possible. Position Summary : The Regulatory Affairs Associate assists in drafting, submitting and gaining clearance for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Qualifications Bachelor's degree in a relevant field (Life Sciences, Quality Assurance, Regulatory Affairs , etc.); advanced degree preferred 7+ years of ... About the Department The Clinical , Medical and Regulatory (CMR) department...seeking a highly organized and detail-oriented Business Process Oversight Manager to oversee all aspects of Good Practice (GxP)… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. The Senior Medical Information Manager is responsible for contributing to the development and implementation of the Medical ... for their assigned therapeutic area. In addition, the Senior Medical Information Manager leads cross functional teams and initiatives to support Medical Affairs… more
- Otsuka America Pharmaceutical Inc. (Oklahoma City, OK)
- …with product strategy and scientific messaging. Collaborate cross-functionally with Medical Affairs , Regulatory , Legal, and Commercial teams to ensure ... The Manager , Medical Core Content is a team-level operational...and production of scientific assets, ensuring they accurately reflect clinical data, adhere to the core scientific narrative, and… more
- Edwards Lifesciences (Lansing, MI)
- …our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for ... continued development of the scientific content repository Other incidental duties: Represent Clinical Affairs in various internal and external programs What… more
- Otsuka America Pharmaceutical Inc. (Ann Arbor, MI)
- …the extraordinary care to the patients they serve. The Rare Disease Account Manager will report directly to the Area Business Lead, Rare Disease, coordinating with ... on approved content in a competitive landscape. Purpose The Rare Disease Account Manager will work collaboratively with cross functional peers to develop a dynamic… more
- BD (Becton, Dickinson and Company) (St. Louis, MO)
- …Marketing, Product Management, Operations, Customer Service, Finance, Legal, and Regulatory Affairs Qualifications: Bachelor's degree required; Master's degree ... account Determine appropriate resources needed to support growth (ie, training, clinical support specialists) Recruit, train, motivate and develop a high performance… more
- Eisai, Inc (Nutley, NJ)
- …Medical, Market Access, Corporate Advocacy, HR, IT, Data Governance, Government Affairs , R&D, etc.) in executing both high-priority strategic initiatives (eg, ... medical review committee submissions. Advise on cross-border data transfers (eg, clinical data) and collaborate with global privacy counterparts to ensure compliance… more
- Insmed Incorporated (NJ)
- …and go-to-market frameworks tailored to dermatologists treating HS.Partner with Medical Affairs and Commercial Effectiveness to ensure key clinical and ... Governance, Supply, Global Brand Strategy Team, etc)Work closely with Legal, Regulatory , Compliance, Medical Affairs , Market Access, Advocacy, and Commercial… more
- Children's Hospital Los Angeles (Los Angeles, CA)
- …Work That Matters.** **Overview** **Purpose Statement/Position Summary:** The Manager , Clinical Research Regulatory Affairs is tasked with oversight ... personal, convenient and empowering. Our scientists will work with clinical experts to take laboratory discoveries and create treatments...and governance of Regulatory Affairs department and involved in the day-to-day support of… more
- AbbVie (Mettawa, IL)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager Regulatory Affairs US Advertising and Promotion ... pharmacology, nursing, pharmacy) plus 7 years of relevant industry experience (eg regulatory affairs fellowship, Health Authority, ad promo, etc.) + Preferred… more
- J&J Family of Companies (Irvine, CA)
- …Learn more at https://www.jnj.com/medtech We are searching for the best talent for a ** Manager , Regulatory Affairs ** . _The preferred location for this role ... and relocation assistance is not provided. **Purpose** : The Manager , Regulatory Affairs , is a...experience in another relevant function such as Quality, Medical, Clinical , R&D ( _6+ years with Advanced Degree_ ).… more
- Abbott (Pleasanton, CA)
- …working mothers, female executives, and scientists **The Opportunity** We are seeking a ** Regulatory Affairs Manager ** to join Abbott's Heart Failure ... CA. As an individual contributor, the function of a Regulatory Affairs Manager is to...guidelines, policies and regulations + Ethical guidelines of the regulatory profession, clinical research and regulatory… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …improvements and other special projects that can carry significant value to multiple Regulatory Affairs activities and teams. Position will be filled in either ... CA or Parsippany, NJ. **EXAMPLE RESPONSIBILITIES:** + Represents regional Regulatory Affairs or may serve as Regional...Clinical , Nonclinical, Biomarkers). + With guidance, defines the regulatory strategy for one or more Gilead products or… more
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