- 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
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Associate Director Regulatory Affairs - APAC** will work ... location in the Diabetes Division. As a manager, the function of an Associate Director Regulatory Affairs , APAC (Asia Pacific) is to combine knowledge of… 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
- 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
- ICU Medical (Southington, CT)
- …will not be discriminated against on the basis of disability. **Title:** * Associate II, Regulatory Affairs * **Location:** *CT-Southington* **Requisition ... for ease of regulatory agency review. . Represents Global Regulatory Affairs at research and development meetings and presents agreed upon regulatory… 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
- Astrix Technology (Fremont, CA)
- Regulatory Affairs Associate Regulatory Affairs Fremont, CA, US Pay Rate Low: 34.00 | Pay Rate High: 36.00 + Added - 07/10/2024 Apply for Job **_Our ... is no satisfactory treatment option to date. The company is looking for a Regulatory Affairs Associate to join the team. This is an amazing opportunity to… 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
- 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
- Takeda Pharmaceuticals (Boston, MA)
- …my knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking an Associate Director, Global Regulatory Affairs in Cambridge, MA with ... the following requirements: Master's degree in Pharmacy, Biomedical Engineering, Regulatory affairs or related field plus 7 years of related experience. Prior… more
- Haleon (Warren, NJ)
- …projects. **What will your individual contribution at Haleon be?** The expectation for the Regulatory Affairs Associate role will be as follows: + Work ... goal. Right now, we're looking for Co-Ops student in Regulatory Affairs to join us to do...extremely useful for Haleon. This role will provide the Associate with the opportunity to learn about FDA submission… 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
- 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
- Randstad US (Newbury Park, CA)
- regulatory affairs senior associate . + newbury park , california (remote) + posted 4 days ago **job details** summary + $35 - $40.41 per hour + contract + ... OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High...8 years of experience skills: GCP (Good Clinical Practice), Regulatory Affairs Operations, Regulatory … more
- Bausch Health (Bridgewater, NJ)
- …and procedures to enhance efficiencies and compliance. + Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and ... and promotion review experience. Broad knowledge of the pharmaceutical industry Regulatory Affairs discipline for prescription drugs. + Medical Device… 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 ... + Experience working with external contractors supporting the work of regulatory affairs is a plus. + Experience authoring and/or implementing processes. +… more
- Boehringer Ingelheim (Ridgefield, CT)
- …For assigned development projects and US marketed products, provide experienced US regulatory leadership to the global and US cross-functional teams. Provide US ... strategic regulatory guidance to facilitate efficient and compliant drug development...Administration + Provide analysis, advice and guidance on US regulatory strategies. + Provide expertise on regulatory … 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