- Ascendis Pharma (Palo Alto, CA)
- …the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology. The Sr . Director , Regulatory Affairs will serve as the ... trials as well as Life Cycle Management Strategies. The Sr . Director will work closely with the...devastating diseases. This position will report to the VP, Regulatory Affairs and ideally be based in… more
- AbbVie (Mettawa, IL)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director , Regulatory Affairs US Advertising and Promotion is ... with recognition of when to consult departmental senior concerning risks. In absence of Director ,...industry experience. Certification a plus + Experience in US Regulatory Affairs Advertising and Promotion preferred +… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Senior Director , Regulatory Affairs Strategy and Compliance is responsible for developing and implementing comprehensive ... regulatory strategies to ensure compliance with global health authorities....of trends and metrics across the development pipeline. The Senior Director will guide and support the… more
- Abbott (Lake Forest, IL)
- …Opportunity** Our location in **Lake Forest, IL** currently has an opportunity for the ** Director of Regulatory Affairs .** The function of a Director ... metrics/information. The individual may plan, direct, coordinate, and control the regulatory affairs activities related to products worldwide. **WHAT YOU'LL… more
- Sanofi Group (Cambridge, MA)
- …departmental activities, and direct reports. + In conjunction with the Sr . Director /Product Support Head, imparts senior regulatory guidance and advice ... **Job Title:** Director , US Regulatory Affairs - Advertising and Promotion **Location:** Cambridge, MA or Morristown, NJ **About the job** Are you ready to… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA-CMC) leads and manages ... regulatory strategies for both development and commercial products. Additionally, the Senior Director is committed to fostering continuous improvement in … more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …their aspirations. Join Kite and help create more tomorrows. **Job Description** The Senior Director , Regulatory Affairs , Advertising and Promotion ... Santa Monica, CA, and will report to an Executive Director in Regulatory Affairs . **Responsibilities:**...ability to work autonomously with minimal oversight from a senior regulatory affairs professional +… more
- ADM (Chicago, IL)
- **96226BR** **Job Title:** Senior Director of Regulatory & Scientific Affairs , Health & Wellness **Department/Function:** Research & Development **Job ... Description:** ** Senior Director , Regulatory and Scientific Affairs , Health & Wellness - Chicago, IL; Decatur, IL; Kennesaw, GA; or Erlanger, KY**… more
- Mohawk Valley Health System (Utica, NY)
- Sr Director Quality Management & Regulatory Affairs - Full Time - Days Department: QUALITY IMPROVEMENT Job Summary The Senior Director of Quality ... and regulatory operations throughout the organization. The Senior Director of Quality Management Systems &... Director of Quality Management Systems & Regulatory Affairs is accountable for developing, leading,… more
- Medtronic (Santa Clara, CA)
- …a strategic and accomplished Sr . Director of Quality Assurance and Regulatory Affairs (QA/RA) to lead and evolve the global quality and regulatory ... days/week. As ** Sr . Director of Quality Assurance and Regulatory Affairs - Endoscopy** **,** your leadership will ensure that patients receive safe,… more
- Merck (Rahway, NJ)
- …to influence and negotiate with key cross functional Leaders is critical. The Senior Director should have strong managerial experience, a high-level strategic ... **Job Description** Reporting to the Executive Director , RIIM, this role will be accountable to...Regulatory Submissions, Management Process, People Leadership, Product Lifecycle, Regulatory Affairs Compliance, Regulatory … more
- United Therapeutics (Eden Prairie, MN)
- …or pharma regulatory experience with a Bachelor's Degree in life sciences, quality, regulatory affairs or a related area of study or 10+ years of biologic ... experience with a Master's Degree in life sciences, quality, regulatory affairs or a related area of...Ability to mentor, coach, guide, and train lower to senior level employees **Preferred Qualifications** + Proficient knowledge of… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- BeOne Medicines (San Mateo, CA)
- **General Description:** BeiGene is seeking an experienced and instrumental regulatory professional to lead US biologics regulatory CMC team. This individual ... in China and cross-functional stakeholders in developing and executing biologics regulatory CMC strategies, oversees CMC-related regulatory submissions and… more
- Providence (Beaverton, OR)
- …product filings in existing and new service areas. Works closely with the Director , Regulatory Affairs to ensure successful management and development ... of Medicare and Medicaid regulatory affairs functions. Works closely with the Sr . Director , Compliance to ensure assist with transition to oversight… more
- Herbalife (Torrance, CA)
- …Global Regulatory Affairs & Product Compliance (NAM) will report to Sr . Director , Regulatory Affairs -Americas and provide leadership and ... Manager, Regulatory Affairs Category: Global Public Affairs Position Type: Regular Full-Time External ID: 16707 Location: Torrance, CA, United States Date… more
- Fresenius Medical Center (Waltham, MA)
- …(Advanced degree such as a Master's, PhD, or MBA is highly preferred). + Regulatory Affairs Certification (eg, RAC) is preferred. + **Experience:** + 12+ years ... portfolio, including IND/CTAs, NDAs, NDSs, MAAs, etc..and other key regulatory submissions. + Collaborate with senior leadership...of experience in regulatory affairs , focusing on regulatory … more
- Takeda Pharmaceuticals (Boston, MA)
- …probabilities of technical success for the solutions. + Effectively represent the Global Regulatory Affairs (GRA) function in senior level interactions at ... for providing strategic guidance and oversight for the delivery of global regulatory strategies to support development of biomarkers, diagnostic tests, devices and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …as follows: + Champions, independently develops and leads the execution of regulatory CMC investigational and/or registration strategies for assigned products as GRA ... and other unique modalities + Represents, contributes and influences Regulatory , Pharmaceutical Development, and Commercial project teams throughout clinical… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies required **Travel:** ... around rare diseases and immune disorders. **Summary:** Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic… more