- 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
- Katalyst HealthCares and Life Sciences (Elk Grove Village, IL)
- Responsibilities: The Regulatory Affairs Manager is responsible and accountable for Company Core Data Sheets (CCDS), Company Core Safety Information (CCSI) ... assess, improve, implement, and maintain associated complex and simple Global Regulatory Affairs and Quality processes and business solutions. Requirements:… more
- Katalyst HealthCares and Life Sciences (Tarrytown, NY)
- …teamwork abilities. Active participation in Lesson learned process, derived from regulatory correspondences. Support TA Labeling team, when required. Participate ... submission, and monitoring of PLAIR activities, prior to new product launch. Manage regulatory correspondence mainly to CDER, FDA, User fee staff, drug listing and… more
- Prestige Recruiting Firm (Clearwater, FL)
- Pre-Market Regulatory Affairs Manager Remote Why Join Us: Be part of an established leader in the aesthetics industry with exciting new innovations Help ... and a supportive company culture About the Role: We're seeking an experienced Pre-Market Regulatory Affairs Manager to drive global regulatory strategy… 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
- IntePros (Audubon, PA)
- IntePros is currently looking for a Regulatory Affairs Associate to join one of our growing Medical Device clients in Audubon, PA. The Regulatory Affairs ... Experience should demonstrate dependability, flexibility and attention to detail. Regulatory Affairs Associate Job Requirements: Under supervision of… more
- Pernod Ricard (Louisville, KY)
- … regulatory teams, legal, Brand Companies, and global Innovation to enable the regulatory affairs compliance support of new Pernod Ricard products sold in and ... regulatory and operations teams to ensure liquid and labeling compliance (eg, GRAS) for the US, Canada and...3-5 years' experience in Alcohol or CPG company in Regulatory Affairs /Quality Assurance with a focus on… 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
- 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
- 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
- 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
- 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
