- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory… more
- Amgen (Washington, DC)
- …your best work alongside other innovative, driven professionals in this meaningful role. ** Regulatory Labeling Strategist, Manager ** **Live** **What you will ... updating pharmaceutical, biotechnology, and/or device product labeling + Labeling or regulatory affairs experience in various therapeutic areas +… 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
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …the Regulatory Affairs , Advertising and Promotion Director. The Senior Manager Regulatory Affairs , Advertising and Promotion will oversee therapeutic ... The Senior Manager position within the Regulatory Affairs department requires the ability...to health authorities + Provide input to management during labeling development and negotiation to reflect commercialization objectives and… 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 ... matters. + Work closely with Upstream Marketing and the Regulatory Labeling Team in developing labeling...Olympus products in the EU. + Interface with International Regulatory Affairs Team to support preparation of… more
- Ascendis Pharma (Princeton, NJ)
- …committed to working together as one team to achieve extraordinary results. The Senior Manager Regulatory Affairs , Advertising and Promotion will be an ... promotion of prescription drug and biologic products. The Senior Manager Regulatory Affairs , Advertising and... impact of new campaign concepts, target, or product labeling , and to provide strategic regulatory guidance… 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
- 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
- Stryker (Shirley, MA)
- We are currently seeking a ** Manager , Regulatory Affairs ** to join our Joint Replacement Division (Mako and Enabling Technologies Business Unit). Ideally, ... or Weston, FL with some workplace flexibility. As the ** Manager , Regulatory Affairs ** , you...with internal teams + Ensure quality and compliance of regulatory submissions, labeling , and marketing materials +… more
- J&J Family of Companies (Raritan, NJ)
- …Information, Pharmacovigilance, etc.) is required. + A minimum of 3 years of Regulatory Affairs experience in product labeling / labeling regulations, ... health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** ...& Johnson Innovative Medicine R&D is recruiting for a Manager , Global Labeling Product Leader. This position… 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
- Amgen (Washington, DC)
- …10 million patients worldwide. It's time for a career you can be proud of. **US Regulatory Affairs Lead -Senior Manager ** **Live** **What you will do** Let's ... Regulatory Team (GRT), they will achieve the desired labeling by developing and implementing regional regulatory ...with a focus on patient safety + Represent regional regulatory affairs as a member of the… more
- Hologic (Marlborough, MA)
- Manager , Global Regulatory Affairs Marlborough, MA, United States The Manager , Global Regulatory Affairs will support leadership, ensuring ... in a matrixed, global organization. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations, Quality, and Research &… more
- Stryker (Weston, FL)
- 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
- Gilead Sciences, Inc. (Foster City, CA)
- …Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across ... concepts and campaigns. You may represent RA Ad/Promo in Regulatory Project Teams. You may also attend labeling...working with external operational contractors supporting the work of regulatory affairs is a plus. + Experience… 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 The ... 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
- ThermoFisher Scientific (Richmond, VA)
- …environment, making sure our food is safe or helping find cures for cancer. The Regulatory Affairs Manager will draft and file documentation and submission ... or related scientific area. **Experience:** + 5 years of medical device, IVD Regulatory Affairs experience to include either 510(k) or PMA, Notified Body… more
- Pfizer (Groton, CT)
- …Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Regulatory Affairs \#LI-PFE ... The **Senior Manager , Global Labeling Lead (GLL)** has...Team and collaborate with stakeholders including Clinical, Medical, Safety, Regulatory , and Commercial + Drive global labeling … more
- Otsuka America Pharmaceutical Inc. (Bismarck, ND)
- …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
