- Insmed Incorporated (NJ)
- …future of science, we're in. Are you?About the Role:We're looking for a Manager, Regulatory Affairs , Tactical Implementation, on the Regulatory Affairs ... possible for patients with serious diseases. Reporting to the Associate Director, Regulatory Affairs , Tactical Implementation, you'll have a critical role in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. We are currently seeking a Global Regulatory Affairs Labeling Operations Intern for Summer 2026. This full-time ... are seeking a detail-oriented and tech-savvy student to join our Global Regulatory Affairs Labeling Operations team as an intern.The Global Regulatory … more
- Boehringer Ingelheim (Athens, GA)
- Description Manager The Manager, Regulatory Affairs ( RA ) Pharma Safety & Efficacy will represent the US regulatory safety and efficacy function in global ... team meetings, planning activities and FDA communications. Associate Director Act as Regulatory Affairs ( RA ) core or subteam member in projects as well… more
- Boehringer Ingelheim (Ridgefield, CT)
- … strategy expertise/knowledge in one or more therapeutic areas. Interact effectively within Regulatory Affairs and across functions, as a US regulatory ... assigned projects, with supervision. With supervision, the Product Group Regulatory Affairs Fellow will: Regulatory ...Regulatory Expert Group (REG), as appropriate. Ensure US RA contributions to all local and global project related… more
- Eisai, Inc (Nutley, NJ)
- …broad pharmaceutical industry experience, including 8 years of direct Regulatory Affairs experience with new/innovative drug registration strategy/submissions. ... Transparency Language:The annual base salary range for the Director, Global Regulatory Affairs , Growth Markets is from :$200,800-$263,600Under current… more
- Formation Bio (New York, NY)
- …treatments to patients faster and more efficiently.About the PositionThe Senior Director, Regulatory Affairs lead is responsible for developing and directing the ... preferred or equivalent relevant experience. Has 10-20 years of Regulatory Affairs experience as well as additional experience in the biopharmaceutical… more
- Insmed Incorporated (NJ)
- …degree (MS, PhD, PharmD) strongly preferredMinimum of 5 years of experience in Regulatory Affairs , with hands-on experience in regulatory submissions across ... for the future of science, we're in. Are you?About the Role:The Global Regulatory Lead (GRL) will be responsible for formulating and implementing global … more
- Gilead Sciences, Inc. (San Mateo, CA)
- …are operating seamlessly connected with the broader enterprise. Partner with Regulatory Affairs , Quality, Technical Development, and Manufacturing stakeholders ... Building Develop a roadmap that fosters innovation to assist where and when CMC RA invest resources and budget. Own continuous improvement of the operating model and… more
- Olympus Corporation of the Americas (Westborough, MA)
- …more about Life at Olympus: https://www.olympusamerica.com/careers . **Job Description** The Sr. Regulatory Affairs ( RA ) Specialist II Digital Health ... applicable federal, state or local law. Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/ RA ) more
- ThermoFisher Scientific (Austin, TX)
- …Information This position is located in Austin, Texas, and is part of the Regulatory Affairs group. This position functions within an office setting, following a ... regulatory compliance in our innovative Animal Health product lines. The Regulatory Affairs Specialist III will be responsible for defining and implementing… more
- Olympus Corporation of the Americas (Westborough, MA)
- …applicable federal, state or local law. Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/ RA ) ... traditional medical devices. This leadership role leads an OSTA Core Regulatory Affairs Team and provides world-class regulatory strategies for digital… more
- Teleflex (Morrisville, NC)
- …and procedures and communicate to internal stakeholders. - Brings Regulatory Affairs questions/issues to the attention of RA management. - Comply with ... Senior Regulatory Affairs Specialist **Date:** Dec 2,...Documentation, and Canadian license submission/amendments. - Communicate with Commercial RA to ensure timely notification of changes as appropriate.… more
- Bausch + Lomb (Columbus, OH)
- …transfers and geographical expansion projects on behalf of the Global Regulatory Affairs department. Responsibilities: Responsible for general knowledge of ... degree, Bachelor's degree preferred (or equivalent) Minimum 1.5 years of Regulatory Affairs Project management experience PMP Certification preferred… more
- Sumitomo Pharma (Frankfort, KY)
- …a dynamic, highly motivated, and experienced leader for the position of Vice President, Regulatory Affairs Oncology . The candidate must be deeply experienced in ... with but not limited to VP Clin Dev and CMO Manage Commercial Regulatory Affairs function and serve as an internal expert on FDA regulations, guidance, and… more
- Dentsply Sirona (Milford, DE)
- …enhancing business relationships. Manages day to day activities for less senior Regulatory Affairs professionals, including but not limited to mentoring, ... Education Bachelor's degree in a relevant field, such as life sciences, regulatory affairs , or a related discipline. Regulatory Certification (such as RAC… more
- Olympus Corporation of the Americas (Westborough, MA)
- …applicable federal, state or local law. Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/ RA ) ... of a high-growth, innovative team, this position oversees collaboration between internal Olympus Regulatory Affairs Teams and external vendors as needed and will… more
- Teleflex (Wyomissing, PA)
- …technology solutions that make a difference in patients' lives. **Position Summary** The Sr Regulatory Affairs ( RA ) Associate will be responsible for a ... Sr. Regulatory Affairs Associate **Date:** Nov 24,... RA Associate will partner with Product Management Regulatory Affairs personnel to support 510(k)s, Canada… more
- Parexel (St. Paul, MN)
- …go-to expert for global labeling, working side-by-side with client teams across Regulatory Affairs , Technical Operations, Safety, and Commercial. You'll help ... This role is ideal for a candidate with a strong background in regulatory affairs , labelling strategy, and cross-functional leadership. It offers the opportunity… more
- GRAIL (Boise, ID)
- …GRAIL products with the FDA and/or global health authorities. Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, ... and review of Standard Operating Procedures and policy guidelines within the regulatory affairs department. Perform other duties as assigned. Required… more
- Meta (New York, NY)
- Summary: We're seeking a regulatory affairs specialist to join our medical devices compliance team. You will get to work on wearables and Software as a Medical ... wrist wearables, and other innovative devices. Required Skills: Medical Devices, Regulatory Affairs Specialist Responsibilities: Interact directly with FDA… more
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