- Aldevron (Miami, FL)
- …procedures and collaborating with cross-functional teams, including Clients, Regulatory Affairs , and Marketing, to develop labeling strategies that align ... labeling integrity.Collaborate with internal stakeholders: Work closely with Regulatory Affairs , Quality Assurance, and Manufacturing teams to ensure… more
- Boehringer Ingelheim (Ridgefield, CT)
- … revision. + Labeling Submissions to FDA - Coordinate preparation of regulatory labeling documents, for example, SPL, MS Word files, Artwork needed for ... management with excellent planning and organization. + Demonstrated knowledge of regulatory labeling and compliance requirements, including technology trends. +… more
- Danaher Corporation (Fargo, ND)
- …procedures and collaborating with cross-functional teams, including Clients, Regulatory Affairs , and Marketing, to develop labeling strategies that align ... labeling integrity. + Collaborate with internal stakeholders: Work closely with Regulatory Affairs , Quality Assurance, and Manufacturing teams to ensure… more
- Takeda Pharmaceuticals (Boston, MA)
- …guidance pertaining to pharmaceutical drug and device. + Serve as the expert for device labeling on the global Regulatory Affairs (RA) Sub team and Global ... hematologic, and other complex diseases. The Global Regulatory Device Labeling Strategy Lead (Senior Manager ) Plasma-Derived Therapies Business Unit (PDT… more
- Olympus Corporation of the Americas (Westborough, MA)
- …more about Life at Olympus (https://www.olympusamerica.com/careers) . **Job Description** Assist the Manager , Regulatory Affairs in obtaining approval to ... -related matters. Work closely with Upstream Marketing and the Regulatory Labeling Team in developing labeling...of Olympus products in the EU. Interface with International Regulatory Affairs Team to support preparation of… more
- Abbott (Santa Clara, CA)
- …location in Santa Clara, CA currently has an on-site opportunity for a **Senior Regulatory Affairs Manager - Transcatheter Mitral and Tricuspid Valve ... Manager is responsible for estimating, allocating and managing Regulatory Affairs resources to accomplish business and...or complex changes to on-market products. + Assessing the regulatory impact of labeling , manufacturing and design… more
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Regulatory Affairs Manager - APAC** position will work ... their glucose levels with our new sensing technology. This ** Regulatory Affairs Manager - APAC**...with product post marketing approval requirements + Review product labeling and promotional materials to ensure compliance with relevant… more
- Hologic (San Diego, CA)
- … Affairs team here in San Diego, and are looking for a Regulatory Affairs Manager , responsible for on-market regulatory activities associated ... Manager , Regulatory Affairs (IVD)... Manager , Regulatory Affairs (IVD) San Diego, CA,...agencies to obtain timely approval. + Provide recommendations on labeling , manufacturing, and analytical and clinical study plans for… more
- J&J Family of Companies (Raritan, NJ)
- …and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory ... Johnson Innovative Medicine R&D is recruiting for an Senior Manager , Global Labeling Product Leader. This position...develop methods for planning, directing, coordinating and controlling the regulatory affairs activities related to new and… more
- Abbott (Alameda, CA)
- …diversity, working mothers, female executives, and scientists. **The Opportunity** This S **enior Regulatory Affairs Manager - APAC** position will work ... glucose levels with our new sensing technology. This **Senior Regulatory Affairs Manager - APAC**...with product post marketing approval requirements + Review product labeling and promotional materials to ensure compliance with relevant… more
- Stryker (Mahwah, NJ)
- We are currently seeking a **Senior Manager , Regulatory Affairs ** to join our Joint Replacement Division (Mako and Enabling Technologies Business Unit). ... Weston, FL with some workplace flexibility. As the **Senior Manager , Regulatory Affairs ** , you...with internal teams + Ensure quality and compliance of regulatory submissions, labeling , and marketing materials +… 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...laws + Principles and requirements of promotion, advertising and labeling + Interpret and apply regulatory requirements.… more
- AbbVie (Pleasanton, CA)
- …or BA in engineering, biology or other health sciences; plus five-year experience in regulatory affairs . + At least three-year experience working in a medical ... implements regulatory activities that support lifecycle management. * Reviews labeling and packaging components to ensure accuracy and compliance with government… more
- Bausch Health (Bridgewater, NJ)
- …and correctly apply them as appropriate in product development and labeling regulatory + Regulatory Affairs Certification by RAPS a plus Benefits ... drive our collective progress and impact. The Associate Director, Regulatory Affairs handles regulatory development...Manager to ensure timely and accurate submissions to Regulatory Authorities + Act as a regulatory … more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Join Gilead and help create possible, together. **Job Description** As an Senior Manager , Global Regulatory Affairs , Precision Medicine, you will help ... schedule in either Parsippany, NJ or Foster City, CA. **Responsibilites:** + Represent Regulatory Affairs Precision Medicine or Dx Regulatory in… more
- BD (Becton, Dickinson and Company) (Durham, NC)
- …us. **Summary:** Reporting to Medication Management Systems (MMS) Pharmacy Automation (PA) Regulatory Affairs Manager , the Senior Specialist, Regulatory ... expertise to MMS-PA platform. This individual conducts the regulatory affairs activities within the MMS-PA platform....Global Product Development System (GPDS) + Serves as a regulatory expert for labeling and promotional materials… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** The AD, Regulatory Affairs Product Labeling Content: Leads and manages the coordination of activities of labeling matters for assigned ... US-specific labeling feedback and needs into Global Regulatory Affairs sub teams. + Labeling...the company, in conjunction with the assigned RA Product Manager in the RA Product Groups. + Continuously identify… more
- Otsuka America Pharmaceutical Inc. (Columbus, OH)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling ,...global regulatory team (GRL, regional leads, CMC-RA, labeling , medical writing, regulatory operations, etc.) to… more
- Bausch + Lomb (Columbus, OH)
- …degree preferred (or equivalent education and experience). Minimum of 6 years in Regulatory Affairs or relevant experience in a regulated environment. Excellent ... strategy, global reporting, administrative documentation, due diligence, market expansion, labeling content, regulatory compliance, regulatory intelligence… more
- Medtronic (Los Angeles, CA)
- …employees in more than 160 countries. A Day in the Life As Senior Regulatory Affairs Specialist, you will develop and implement medical device regulatory ... from worldwide regulatory bodies. Working with global Regulatory Affairs colleagues, you will ensure submissions...level. All significant issues will be reviewed with the manager . + Maintain proficiency in global regulatory … more
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