- Evident Scientific (Waltham, MA)
- Executive Director , Regulatory Affairs & Quality Assurance. Job ID #: 2023 Company: Evident Posting Date: Jun 3, 2025 **Working Location:** **MASSACHUSETTS, ... every day. **Let's inspire healthier lives, together.** **Job Description** The Executive Director , Quality and Regulatory Affairs (Exec Dir QARA),… more
- Kemin Industries (Des Moines, IA)
- Overview Kemin Health is hiring an Associate Director of Regulatory /Scientific Affairs and Quality ! In this role, you will be responsible for leading the ... business units' regulatory affairs (RA) and quality assurance (QA)...Project Verification. + Stay abreast of the changing regulatory , legal, quality and competitive landscape. +… more
- Boehringer Ingelheim (St. Joseph, MO)
- …Profile/Target Product Profile and Quality Target Profile. + Provide consistent regulatory advice to project teams regarding the pathways and approaches to ... team meetings, planning activities and FDA communications. Associate Director Act as Regulatory Affairs (RA) core...to drive Target Product Profile objectives. + Provides consistent regulatory advice to project teams regarding the… more
- Takeda Pharmaceuticals (Boston, MA)
- …following job opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** : Associate Director , Regulatory Data Governance Lead **POSITION DESCRIPTION** : Takeda ... Development Center Americas, Inc. is seeking an Associate Director , Regulatory Data Governance Lead with the following duties: Oversee the establishment of … more
- Bayer (NJ)
- …of brilliant and diverse minds to make a real difference, there's only one choice.** ** Director US Regulatory Affairs Liaison** The Director US Regulatory ... registrations. **YOUR TASKS AND RESPONSIBILITIES** The primary responsibilities of this role, Director US Regulatory Affairs Liaison, are to: + Demonstrates,… more
- Cardinal Health (Phoenix, AZ)
- …brand for post-approval success in obtaining the greatest market share possible. The Director , Business Development with Cardinal Health Regulatory Sciences is a ... **Position Summary** For nearly five decades, Cardinal Health Regulatory Sciences' industry-trained regulatory consultants have provided expertise and guidance… more
- Edwards Lifesciences (Irvine, CA)
- …we are supporting the needs and interests of the patients we serve. The Senior Director , Corporate & Regulatory Counsel role is a blend of subject matter legal ... expert and strong business acumen. The Senior Director , Corporate & Regulatory Counsel will have...legal guidance on the Company and TAVR business's commercial, regulatory , clinical and quality legal issues, this… more
- Lilly (Indianapolis, IN)
- …as appropriate. + Assures that the organization adheres to standards defined in the Regulatory Quality System (RQS). + Assures that key business practices are ... determined to make life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA-CMC) leads and manages the… more
- Ascendis Pharma (Palo Alto, CA)
- …Today, we're advancing programs in Endocrinology Rare Disease and Oncology. The Sr. Director , Regulatory Affairs will serve as the therapeutic area head for ... the US RA Strategy team. This role involves managing regulatory submissions and providing strategic leadership to ensure the...as well as Life Cycle Management Strategies. The Sr. Director will work closely with the executive team to… more
- Sanofi Group (Cambridge, MA)
- … regulatory positions and regulatory dossier templates + Act as the Regulatory Affairs-Devices lead on assigned project teams (early phase, late stage and ... **Job Title:** Global Regulatory Affairs Device Head, Specialty Care Device and...Device Head, Specialty Care Device and Combination Products (Sr. Director ) **Location** : Cambridge, MA or Morristown, NJ **About… 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 of ... regulated industry (eg, medical products, nutritional). 7-10 years of experience in regulatory preferred but may consider quality assurance, research and… more
- Mount Sinai Health System (New York, NY)
- **Job Description** **System Senior Director , Regulatory Compliance- Mount Sinai Health System** The Senior Director for Regulatory Affairs is ... responsible for assisting the Vice President, Quality and Regulatory Affairs, MSHS, in maintaining...preferred. Prior leadership roles important, as is experience managing project groups. Non-Bargaining Unit, 620 - HSO Regulatory… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …functional CMC team SME members that may include, Development Manufacturing Supply and Quality (DMSQ), Regulatory Project Management & Program management, ... Regeneron Cell Medicine is looking for an Associate Director in Regulatory CMC for biologics...regulatory strategies and the preparation and submission of high‑ quality CMC sections of INDs, CTAs, and original marketing… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …grow and become your best self. Become a **maker of possible** with us. The Sr. Director , Regulatory Affairs is the ranking Regulatory Affairs leader for the ... and teamwork skills + Current and comprehensive knowledge of global regulations and quality systems are required + Strong project coordination, business acumen… more
- Herbalife (Torrance, CA)
- Director , Global Regulatory Affairs - Corporate...key goals are met on time. + Represents corporate regulatory affairs team on project teams and ... leaders. + Owns the development and management of corporate project plans and timelines and assigning and managing resources...+ Ability to successfully chip in to improving the quality of internal regulatory policies, processes, programs… more
- Catholic Health Initiatives (Houston, TX)
- **Responsibilities** The Region Director Regulatory Readiness is responsible for providing direction and support to the hospitals and other entities within a ... Commission (TJC), Det Norske Veritas (DNV GL), Center for Improvement in Healthcare Quality (CIHQ), and other regulatory agencies (eg State Licensing). This… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …documents focused on strategic and scientific content. + Build, lead and mentor the regulatory team and provide project teams with the strategic regulatory ... and internal stakeholders. A typical day as an Executive Director might look like: + Responsible for the strategic...investigational and commercial products + Directs and oversees the Regulatory CMC function in preparing high- quality CMC… more
- Lilly (Indianapolis, IN)
- …and evaluate global CMC regulatory strategies in collaboration with other regulatory , manufacturing, quality and project personnel to enable timely ... who need them all over the world. The Senior Advisor/ Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use… more
- Takeda Pharmaceuticals (Lexington, MA)
- …therapies and other unique modalities + Represents, contributes and influences Regulatory , Pharmaceutical Development, and Commercial project teams throughout ... a GRA CMC member, ensures and / or enhances regulatory compliance. + Ensures project team colleagues,...regulatory individuals to ensure timely delivery of high quality of regulatory dossiers and strategies according… more
- Edgewell Personal Care (Allendale, NJ)
- …stewardship. + Subject matter expert support during inspections by health authorities, or regulatory bodies. + Translate project calendars into Regulatory ... the Global R&D organization who oversees all activities related to regulatory compliance across all Edgewell's brand portfolio. Responsible for assessing,… more
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