- Bausch Health (Bridgewater, NJ)
- …on new product opportunities. Key Responsibilties: + Responsible for developing a product regulatory strategy for pharmaceutical products + Liaise with ... approved products (NDA; ANDA; BLA; OTC; Devices; Cosmetic; Nutritional). Manages relevant regulatory strategy components and interactions with Regulatory … more
- Bausch Health (Bridgewater, NJ)
- …of the product development team to provide regulatory guidance for pharmaceutical products. Manages relevant regulatory strategy components and ... on new product opportunities. Key Responsibilities: + Responsible for establishing a product regulatory strategy for pharmaceutical products in the assigned… more
- Fresenius Medical Center (Waltham, MA)
- …of high-quality pharmaceutical products. **PRINCIPAL DUTIES AND RESPONSIBILITIES:** + ** Regulatory Strategy Leadership:** + Lead the development of global ... the pharmaceutical industry. + Proven experience in leading global regulatory strategy for complex pharmaceutical products across multiple regions (FDA,… more
- Gilead Sciences, Inc. (Foster City, CA)
- … regulatory lead you will also be responsible for ensuring that global regulatory strategy is integrated into Pharmaceutical Development & Manufacturing ... CMC Regulatory Affairs for Biologics is responsible for defining regulatory strategy for one or more molecules in the Biologics portfolio. This position… more
- Bausch Health (Bridgewater, NJ)
- …support compliance. Key Responsibilities: + Provide support for the execution of the pharmaceutical regulatory brand strategy for assigned products + Support ... and impact. The Senior Specialist Regulatory Affairs executes on the pharmaceutical regulatory strategies for assigned brand products. Supports for Brand… more
- Takeda Pharmaceuticals (Boston, MA)
- …This role serves as the single point of contact for R&D CMC Portfolio Strategy enabling activities on behalf of the CMC community within R&D, but also in ... office), portfolio insights and portfolio stakeholder management. + **R&D CMC Strategy Leader & Stakeholder Management:** Accountable for oversight of the Pharm… more
- 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)
- …to apply for the position in Germany, please use this link: Global Regulatory Strategy Lead - CNS, Retinal Health & Emerging Areas (boehringer-ingelheim.com) ... reflect Boehringer Ingelheim's high regard for our employees. The Director, Global Regulatory Strategy Lead will provide strategic regulatory guidance… 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
- CVS Health (Woonsocket, RI)
- …objectives. In this role, you will work with Trade leadership to formulate strategy regarding pharmaceutical purchases and rebates and other partnerships within ... day. **Position Summary** As a Senior Legal Counsel - Pharmaceutical Contracting, you will provide strategic legal advice and...to develop a keen understanding of the enterprise Trade Strategy , operational goals, and work diligently to develop and… 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 (Falls Church, VA)
- **Head of Regulatory Strategy , Patient Centered Solutions** **Overview** IQVIA provides scientific services spanning clinical trials, real world evidence, and ... environment + Experience of medical writing for various audiences, including pharmaceutical companies, healthcare professionals, regulatory bodies and patients +… 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
- System One (Florham Park, NJ)
- …to Align Regional Strategies and Submissions with Global Development Plans and Regulatory Strategy Plans ESTABLISH DELIVERABLES & PERFORMANCE EXPECTATIONS + ... advanced degree preferred. + 7+ years of experience in regulatory affairs within the pharmaceutical or biotech...development (as needed) + Contributions to and finalization of regulatory strategy plans and implementation for antivirals… 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
- CBRE (Pennington, NJ)
- Chief Building Engineer- Pharmaceutical : Pennington, NJ Job ID 213359 Posted 06-May-2025 Service line GWS Segment Role type Full-time Areas of Interest ... access to our Best-in-Class services, including ESG, Security Consulting, Workplace Strategy , and Workplace Experience. About the role Responsible for engineering… 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
- 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
- Xcelerate Solutions (Frederick, MD)
- Program Analyst IV - Medical Regulatory & Acquisition Strategy Xcelerate Solutions is seeking a Senior program analyst who will support Joint Program Executive ... Office for CBRN Defense (JPEO-CBRND) Medical Regulatory and Acquisition Strategy (MRAS) team. In...ensure compliance with regulation + Monitor EVMSs appropriate for pharmaceutical development and within the constraints of the FDA… more