- American Heart Association (Washington, DC)
- …your career. The **American Heart Association** has a phenomenal opportunity for an ** Associate ** ** Regulatory Affairs Manager** with our Federal Advocacy ... work arrangements available. Under the direction of the Director, Federal Regulatory Affairs , you would be responsible for monitoring, analyzing, and drafting… more
- Taiho Oncology (Princeton, NJ)
- Associate Director, Regulatory Affairs Strategy Princeton, NJ, USA Req #415 Wednesday, November 27, 2024 Looking for a chance to make a meaningful difference ... filing in US and Europe. Position Summary: + Under the direction of regulatory affairs management, the incumbent independently prepares and directs global … more
- Ascendis Pharma (Princeton, NJ)
- …and committed to working together as one team to achieve extraordinary results. The Associate Director Regulatory Affairs , Advertising and Promotion will be ... governing the promotion of prescription drug and biologic products. The Associate Director Regulatory Affairs , Advertising and Promotion is responsible for… more
- Ascendis Pharma (Palo Alto, CA)
- …offer a dynamic workplace for employees to grow and develop their skills. The Associate Director, Regulatory Affairs will be responsible for developing and ... are technically complex and require extensive interaction with departments outside of regulatory affairs . + Excellent organizational skills and ability to work… more
- Sumitomo Pharma (Columbus, OH)
- …currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director, Regulatory Affairs ** . The Associate ... Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will...pharmaceutical industry with minimum of 6 years focused in Regulatory Affairs + Include the qualifications preferred… more
- ICU Medical (Lake Forest, IL)
- *Position Summary* The Regulatory Affairs Associate will assist with 510(k) submissions,International Licensing and Submissions, and respond to routine ... regulatory queries for information and documents. The Regulatory Affairs Associate will also complete International product registrations and export… more
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Associate Director Regulatory Affairs - US New Product ... is helpful. + Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) + Previous experience with 510k / PMA / DeNovo submissions… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Associate Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly ... focus on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities will… more
- Gilead Sciences, Inc. (Foster City, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** **Sr Associate , Regulatory Affairs , CMC** **Foster City, California** ... market applications and supplements/variations with limited management supervision. + Represent Regulatory Affairs (RA) CMC on product development and life-cycle… more
- J&J Family of Companies (Horsham, PA)
- Johnson & Johnson is recruiting for an Associate Director, CMC Regulatory Affairs . This position can be located in Spring House, PA; Horsham, PA; Titusville, ... the product and is in alignment with the strategies of global regulatory affairs , the therapeutic area, commercial, regional functions and the Quality Target… more
- Boehringer Ingelheim (Ridgefield, CT)
- …on patients' lives? Boehringer Ingelheim is seeking a dedicated and innovative Director/Senior Associate Director, Global Regulatory Affairs CMC for Chemical ... to the continuous improvement of processes and standards within Regulatory Affairs . If you have a strong...for our employees. The GRL CMC Director or Senior Associate Director has responsibility for the strategic global CMC… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. As an Associate Director, Global Regulatory Affairs Marketed Products you will ... area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively… more
- Englewood Lab, Inc (Totowa, NJ)
- Title: Regulatory Affairs Associate Reports to: Manager of Regulatory Affairs Department: Quality/ Regulatory Responsibilities: + Assist the ... Manager of Regulatory Affairs to create and collate product master files (dossiers),...ISO 13485:2003, COSMOS/ECOCERT, etc). + Assist the Manager of Regulatory Affairs for facility registrations, renewals, and… more
- Kemin Industries (Des Moines, IA)
- Overview Our Food Technologies team is hiring a Regulatory Affairs Associate ! In this role, this person will be responsible for preparing regulatory ... the databases and trackers in real time. This person may also represent Regulatory Affairs on project teams, as more experience is acquired. This role will… more
- 3M (Maplewood, MN)
- Job Description: Job TitleSenior Regulatory Affairs Associate Collaborate with Innovative 3Mers Around the World Choosing where to start and grow your career ... to a 3M career. The Impact You'll Make in this Role As a Senior Regulatory Affairs Associate , you will have the opportunity to tap into your curiosity and… more
- Dorsey & Whitney LLP (Anchorage, AK)
- Regulatory Affairs Associate (#856) Dorsey and Whitney LLP is seeking a Regulatory Affairs Associate with four to six years of experience to join ... the Anchorage office. This associate will have the opportunity to work on a wide variety of issues and matters, including corporate and municipal governance,… more
- Takeda Pharmaceuticals (Columbus, OH)
- …application is true to the best of my knowledge. **Job Description** The Regulatory Affairs -Labeling, Associate Director is responsible for ensuring that ... to the world. **How you will contribute:** + The Associate Director, GRA Labeling Compliance, is responsible for the...global and local labeling compliance and quality within Global Regulatory Affairs . + Partners with internal stakeholders… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …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 ... + Experience working with external contractors supporting the work of regulatory affairs is a plus. + Experience authoring and/or implementing processes. +… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …More Years in the pharmaceutical industry preferred + 1 or More Years in regulatory affairs required + Experience in (s)NDA/BLA filing to FDA preferred ... with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development...will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + Experience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more