- System One (Plainsboro, NJ)
- …strategy. This individual works cross-functionally with internal and external departments on Regulatory Affairs labeling related issues. RELATIONSHIPS: + ... Job Title: Regulatory Labeling Specialist Compensation: $95000 -...working relationships with company stakeholders. + Effective collaboration with Regulatory Affairs , CMR, Supply Chain, and HQ… more
- Boehringer Ingelheim (St. Joseph, MO)
- **Description** Manager The Manager , Regulatory Affairs (RA) Pharma Safety & Efficacy will represent the US regulatory safety and efficacy function ... and submissions for their assigned projects. This role is responsible for linking regulatory affairs information to internal and external stakeholders (FDA) to… 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)
- …in Santa Clara, CA currently has an on-site opportunity for a **Senior Regulatory Affairs Manager - Transcatheter** **Mitral Valve Replacement** within ... 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 (Sylmar, CA)
- …fingersticks. Our location in **SYLMAR, CA** currently has an onsite opportunity for a Manager of Regulatory Affairs in the Cardiac Rhythm Management ... The Manager is responsible for estimating, allocating and managing Regulatory Affairs resources to accomplish business and corporate objectives. Knowledge… 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 (Marlborough, MA)
- …based out of our San Diego or Marlborough campus, and are looking for a Regulatory Affairs Manager , responsible for on-market regulatory activities ... Manager , Regulatory Affairs (IVD...agencies to obtain timely approval. + Provide recommendations on labeling , manufacturing, and analytical and clinical study plans for… more
- Abbott (Sylmar, CA)
- …of device and Cardiac Rythm Management solutions The Opportunity - We are seeking a Regulatory Affairs Project Manager to join our Cardiac Rythm Management ... CA. As an individual contributor, the function of a Regulatory Affairs Project Manager is...appropriate); + Medical writing + Advertising and promotion + Labeling + Restricted substances reporting as required(eg REACH) +… 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
- Bausch Health (Bridgewater, NJ)
- …guidance and correctly apply them as appropriate in product development and labeling regulatory + Regulatory Affairs Certification by RAPS a plus As ... 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
- Novo Nordisk (Plainsboro, NJ)
- … agencies. Supervise designated personnel. Relationships Report to the Director Regulatory Affairs . Develop and maintain positive rapport and working ... relationships with other personnel in Regulatory Affairs , CMR, and other local and...Functions + Compile and submit responses to FDA communications. MANAGER , THERAPEUTIC AREA: Compile, submit and maintain applications (IND,… 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
- Medtronic (Lafayette, CO)
- …more connected, compassionate world. **A Day in the Life** We are seeking a Senior Regulatory Affairs Specialist to join our team within Medtronic Acute Care and ... and review process + Provide business and product information to the international regulatory affairs team to enable development and strategies and requirements… more
- BD (Becton, Dickinson and Company) (Covington, GA)
- …all project stakeholders at UCC, including stakeholders at multiple sites (eg, regulatory affairs , quality assurance, labeling , manufacturing, sourcing, ... Support protocol development and product evaluations for design changes + Ensure regulatory compliance of all labeling materials + Facilitate cross-functional… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …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
- Edwards Lifesciences (Irvine, CA)
- …difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex ... domestic and international regulatory environments. Working in...and leading teams to implement solutions.* Review promotional material, labeling content, product and process changes, and product documentation… more
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …issues, and export and labeling requirements, with some oversight from more senior regulatory specialist / manager . + May begin to mentor or train more ... As a member of the Regulatory Affairs team, the Regulator ...policies and procedures. + Perform assessment of change requests (device/ labeling ), with minimal oversight. + Write or update standard… more
- Abbott (Alameda, CA)
- …the Diabetes Division. As a manager , the function of an Associate Director Regulatory Affairs , APAC (Asia Pacific) is to combine knowledge of scientific, ... female executives, and scientists. **The Opportunity** This **Associate Director Regulatory Affairs - APAC** will work on-site...approve labeling to ensure compliance. + Represent regulatory affairs in product recall and recall… more
- Bausch Health (Bridgewater, NJ)
- …skills and values drive our collective progress and impact. The Senior Specialist Regulatory Affairs executes on the pharmaceutical regulatory strategies for ... team for agency filing + Work with the Pharmaceutical Regulatory Brand Senior Manager to make certain...Authorities for assigned brand products + Liaise with country-specific regulatory affairs personnel for international submissions and… more
- Bausch Health (Bridgewater, NJ)
- …skills and values drive our collective progress and impact. The Director of Regulatory Affairs coordinates and oversees regulatory development and ... industry and regulatory experience + Knowledge of pharmaceutical brand industry regulatory affairs discipline throughout the product lifecycle + Knowledge of… more
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