Regulatory Manager - Remote, United States

+Job summary · We unite all grid interconnection stakeholders on a single platform that converts centralized data into actionable intelligence and accelerates the transition to a reliable, sustainable, and cost-efficient electric grid.Serve as a senior individual contributor resp ...

The Regulatory Manager provides regulatory development advice and guidance for optimal conduct of clinical trials, · ensuring timely preparation of well organized, quality regulatory submissions in compliance with applicable regulations. · The RM coordinates and prepares regulato ...

This position provides global regulatory strategy for Software as a Medical Device (SaMD), including cloud-based software platforms, AI/ML-enabled technologies and digital health solutions. · The role supports product development integration product launch premarket submissionsre ...

The Regulatory Affairs Program Manager supports the development oversight and implementation of regulatory programs that support performance at or above federal and state standard requirements contractual obligations and internal standards. · Program Managers serve as strategic p ...

Join one of the nation's leading and most impactful health care performance improvement companies. Over the years, Health Catalyst has achieved and documented clinical, operational, and financial improvements for many of the nation's leading healthcare organizations. We are also ...

The Director Global Regulatory Project Management is responsible for supporting influencing translating executing oncology regulatory strategies across drug development lifecycle. · ...

Pulmovant is a Roivant-backed clinical-stage biotechnology company developing innovative therapies for patients suffering from pulmonary diseases. · Able and willing to do hands on document formatting and regulatory publishing. · Responsible for all documents and submissions to b ...

The Associate Director Global Regulatory Project Management (AD GRPM) drives successful NDA BLA MAA submissions ensuring cross-functional integration across regions. · ...

This position may be performed remotely, but requires the flexibility and willingness to travel as needed. · Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline (advanced degree preferred). · 5+ years of Re ...

+Job summary · The Senior Manager Regulatory CMC will be responsible for the planning preparation and execution of Chemistry Manufacturing and Controls CMC regulatory activities for investigational and commercial products including small molecule and antisense oligonucleotide ASO ...

· Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates it—w ...

We are seeking a motivated Regulatory Affairs Consultant – Advertising & Promotion to join Parexel and work as a trusted partner within a major client engagement. · Key Responsibilities · Review and approve advertising and promotional materials. · Provide regulatory guidance to c ...

+Job summary · Senior Director, CMC Regulatory Affairs is responsible for leading the development, execution, and maintenance of global CMC regulatory strategy to support clinical development,+QualificationsAdvanced degree (MS, PhD, PharmD) in Chemistry...++Strategic Leadership- ...

The Director Quality Management Organization QMO provides visionary strategic operational and technical leadership to ensure the highest standards of quality and regulatory compliance across a diverse research enterprise This critical role commands a broad span of control oversee ...

This position reports to the Functional Area Head, Global Regulatory Affairs. The incumbent is responsible for supporting the development and implementation of regulatory strategies. · Actively contribute to the development of regulatory strategies. · Participate as Global Produc ...

· The Regulatory Compliance Analyst will be part of the National Program Operations Team and report to the Director of EPR Regulatory Compliance. This position will provide regulatory and technical guidance on the development and implementation of extended producer responsibilit ...

+Job summary · Hims & Hers is seeking a VP of U.S. Regulatory Affairs to lead the company's regulatory strategy, · +Lead the development of the company's U.S. regulatory strategy for digital health, telemedicine, pharmacy, and consumer products.Oversee all regulatory filings, sub ...

We are seeking an Associate Director of Regulatory Affairs CMC to develop and implement global regulatory strategies for assigned product(s) in line with business objectives. · ...

The Director Global Regulatory Lead will develop implement advise on global regulatory strategies for development programs to secure maintain market access for products in line with business objectives. · The incumbent will manage regulatory aspects of compounds through all phase ...

We are seeking an experienced Director of Global Regulatory Affairs to lead our regulatory strategies for development programs. As the key contact with global regulatory authorities you will develop implement advise on strategies. · ...