- PCI Pharma Services (Bedford, NH)
- …position. **Essential Duties and Responsibilities:** + Responsible for the leadership and strategy of the Pharmaceutical Development groups within PCI Pharma ... People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the… more
- Boehringer Ingelheim (Ridgefield, CT)
- …areas of pharmaceutical law, one of which must be FDA Regulatory (eg, Transactions, FDA Regulatory , Commercial, Litigation, Clinical Trials, etc.) critical ... Disease pharmaceutical products. + Experience in FDA prescription drug regulatory matters including experience in the federal Anti-Kickback + Statue, False… more
- AbbVie (Waltham, MA)
- …. Job Description The Director, Oncology Business Development and Global Regulatory Strategy is responsible for developing and implementing globalstrategies ... global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the... experience. Some portion may include experience related to pharmaceutical regulatory work (eg, other R&D role… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the ... development and implementation of labeling content and strategy of multiple products in various stages of drug development, assigned to self or direct reports,… more
- IQVIA (Wayne, PA)
- …growth. **Role & Responsibilities** The Head of the Center of Excellence (CoE) for Regulatory Strategy sits within the COA consulting business of PCS and plays ... environment + Experience of medical writing for various audiences, including pharmaceutical companies, healthcare professionals, regulatory bodies and patients +… more
- System One (Florham Park, NJ)
- …for hybrid schedule - fully remote is NOT an option. + Must have regulatory strategy experience in IND/NDA development, not just life cycle management. Overview ... to Align Regional Strategies and Submissions with Global Development Plans and Regulatory Strategy Plans ESTABLISH DELIVERABLES & PERFORMANCE EXPECTATIONS +… more
- AbbVie (San Francisco, CA)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager, RA Global Regulatory Strategy , US & Canada position is responsible for the ... Lead (GRL), Associate Director, or Director), in the development & execution of the regulatory strategy . Assigned matters may have a moderate impact on business… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …in support of organizational development and marketing objectives. + Designs regulatory communication strategy for Oncology & Malignant Hematology product ... The role leads a group within Regeneron's Regulatory Affairs organization that provides guidance to Research,...Malignant Hematology. + A minimum of 15 years of pharmaceutical industry or related experience, at least 5 of… more
- NTT America, Inc. (NY)
- …adaptable, and forward-thinking organization, apply now. We are currently seeking a Pharmaceutical Manufacturing Intelligence Consultant - REMOTE US to join our team ... commercialization processes. Practice specialties include preclinical discovery, clinical trials, regulatory quality and compliance, medical affairs, pharmacovigilance, manufacturing and… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The 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...you bring strong understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard… more