- IQVIA (Durham, NC)
- …( Associate ) Director will play a critical role in supporting the Regulatory Affairs and Drug Development Solutions (RADDS) team-not through direct sales, ... alignment to help drive success. This is role focuses on the Drug Development & Regulatory Strategy (DDRS) offerings within RADDS. The individual will be focused… more
- Takeda Pharmaceuticals (Boston, MA)
- …for the 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… more
- Lilly (Indianapolis, IN)
- …that advance patient outcomes, reduce regulatory risk, and improve efficiency in drug development. The purpose of the Associate Vice President - Global ... which will center around topics that encourage innovation in drug development and regulatory review of genetic and neuroscience medicines + Critically review… more
- Boehringer Ingelheim (St. Joseph, MO)
- …such as governance review, project team meetings, planning activities and FDA communications. Associate Director Act as Regulatory Affairs (RA) core or subteam ... **Description** Manager The Manager, Regulatory Affairs (RA) Pharma Safety & Efficacy will...as defined. + Supports specific infrastructural projects as assigned. Associate Director + Responsibility for the safety and efficacy… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. The Associate Director Global Regulatory Affairs, Neuroscience is responsible for ... experience. + Preferred experience in reviewing, authoring, or managing components of regulatory submissions. + Solid working knowledge of drug development… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …+ Extensive experience developing companion diagnostics and devices. + Experience of drug development and drug regulatory procedures. + Understanding ... of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization process. + Experience with… more
- Gilead Sciences, Inc. (Foster City, CA)
- …& Drug Administration (FDA) and European Medicines Agency (EMA) regulatory requirements and International Council for Harmonisation of Technical Requirements for ... create possible, together. **Job Description** You will act as the Regional Regulatory Lead on more complex or multiple products, compounds, indications or projects… more
- Rhythm Pharmaceuticals (Boston, MA)
- …learn, and our tenacity to overcome barriers, together. Opportunity Overview In the Associate Director, Regulatory Affairs role, you will be responsible for ... degree in life sciences preferred + 8+ years of Regulatory Affairs experience in drug development and...8+ years of Regulatory Affairs experience in drug development and product registration activities within the pharmaceutical… more
- GRAIL (Washington, DC)
- …technology, and healthcare companies. For more information, please visit grail.com . The Associate Director of Global Regulatory Affairs & Safety serves as a ... GRAIL's UK Responsible Person (UKRP). Interfaces with MHRA and other International regulatory agencies, Notified Bodies, and external consultants as needed, on IVD… more
- J&J Family of Companies (Spring House, PA)
- …Johnson & Johnson Innovative Medicine R&D is recruiting for an Associate Director, North America Regulatory Leader. This position is ... We invite candidates from any location to apply. The Associate Director, Regulatory Leader in Global ...regulated industry experience is required. + Knowledge of the drug product lifecycle from discovery to clinical trials to… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director Global Regulatory Lead, GRAD Oncology. You will provide ... experience. + Preferred experience in reviewing, authoring, or managing components of regulatory submissions. + Solid working knowledge of drug development… more
- Gilead Sciences, Inc. (Foster City, CA)
- …BA/BS with 10+ years' relevant experience. + 4+ years' experience in prescription drug labeling. + Significant regulatory experience in the biopharma industry is ... their aspirations. Join Gilead and help create possible, together. **Job Description** Regulatory Affairs Labeling is a core function within Gilead's Global … more
- Takeda Pharmaceuticals (Boston, MA)
- …experience + Preferred experience in reviewing, authoring, or managing components of regulatory submissions. + Solid working knowledge of drug development ... + Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple… 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) teams by...accommodation will be considered. A post-offer background check and drug screen is required. Additional pre-employment requirements may be… more
- Bausch Health (Bridgewater, NJ)
- …itwhere your skills and values drive our collective progress and impact. The Associate Director, Regulatory Affairs handles regulatory development and ... Participates on the product development/life-cycle management team to provide regulatory guidance for assigned pharmaceutical products. Primary focus on approved… more
- AbbVie (North Chicago, IL)
- …drug development, including on clinical trial design and study requirements, regulatory exclusivities, orphan drug designations, and combination products, and ... YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description As an Associate General Counsel in the R&D Innovation Legal group, you will support… more
- Stryker (Portage, MI)
- Stryker is hiring an ** Associate Manager, Regulatory Affairs** preferrable in **Portage, MI,** to join our **Craniomaxillofacial (CMF)** **Business!** In this ... role, you will lead and manage a team of regulatory professionals to ensure compliance with applicable regulatory requirements at the local, state, and federal… more
- Fresenius Medical Center (Waltham, MA)
- …AND SCOPE:** Assists in the support of the daily operational activities within Regulatory Operations for the preparation of regulatory submissions required to ... Instructions (WIs), and operational processes, ensuring alignment with evolving regulatory requirements, internal standards, and best practices. . **PRINCIPAL DUTIES… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- … regulatory processes. Additional Responsibilities: + Maintain awareness of all regulatory activities regarding new and approved drug products. Stay current ... and company goals and objectives. Essential Functions: + Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and clinical regulatory … more
- Lilly (Philadelphia, PA)
- …through philanthropy and volunteerism. **Position Overview:** The Manager - CMC Regulatory is responsible for the preparation and delivery of high-quality CMC ... regulatory submissions. This position supports Lilly/Avid diagnostic radiopharmaceutical marketed...vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (eg, healthcare and/or dependent day… more