Executive Director, Regulatory Strategy - San Diego

+The Executive Director, Regulatory Strategy – Endocrinology is a senior regulatory leader responsible for shaping and driving global regulatory strategy across Neurocrine's Endocrinology pipeline. · +Learns the development and execution of innovative, global regulatory strategie ...

Who We Are: · At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering ...

Job summary · The Executive Director of Regulatory Strategy will lead the development and execution of global regulatory strategies across Neurocrine's Endocrinology pipeline. · ...

We are committed to bringing medicines to the world faster without compromising on excellence and integrity. · ...

+h2>Job summary · seeking an experienced Executive Director of Regulatory Affairs to lead global regulatory strategy for a late-stage development program. · Lead the development and execution of global regulatory strategy for Phase 2 and Phase 3 programs · Serve as the regulatory ...

The Director, CMC Regulatory Affairs will lead CMC regulatory strategy and execution in support of global clinical development programs.This role serves as the regulatory lead on cross-functional CMC teams and is responsible for authoring, managing, and overseeing high-quality gl ...

The Director of Regulatory CMC will lead strategic regulatory compliance for assigned commercial products and development projects to ensure timely and efficient preparation and clearance/approval of IND/CTA/MAA/NDA/BLA submissions. · ...

We are seeking a detail-oriented Regulatory Affairs Specialist to support US and global medical device submissions. · Prepare and manage global regulatory submissions and registration dossiers. · Ensure compliance with FDA, EU MDR, and worldwide regulatory requirements. · ...

Provide regulatory support and expertise associated with US and global submission requirements. · Bachelor's Degree required, preferably in pharmacy, biology, chemistry, pharmacology, engineering or related subject. · ...

Provide regulatory support and expertise associated with US and global submission requirements including analysis of the requirements and tracking of deliverables. Assures full regulatory compliance of all documentation for submissions and change management to enable product appr ...

This person will be responsible for the development and execution of global regulatory strategy across the company's clinical portfolio. · ...

The AD, CMC Regulatory Affairs will lead CMC regulatory strategy and execution in support of global clinical development programs. · Serve as CMC regulatory lead, providing strategic guidance and regulatory oversight. · ...

The Director, Regulatory Affairs will support the development and execution of domestic and international regulatory strategy for Codera.This position involves planning, preparing, authoring and/or reviewing documents for inclusion in regulatory submissions, · including medical w ...

We are seeking a Regulatory Affairs Associate to support U.S. and global regulatory submissions for medical device products. · Bachelor's Degree required, preferably in pharmacy, biology, chemistry, pharmacology, engineering or related subject. · 2–4 years of Regulatory Affairs e ...

We are seeking a Regulatory Affairs Specialist to provide regulatory support and expertise for U.S. and global medical device submissions. · ...

+The Vice President of Regulatory Affairs will serve as a key strategic leader overseeing global regulatory planning and execution for development programs. · +Advanced degree in a scientific or medical field (e.g., PharmD, PhD, MD, MS) · 10+ years of experience within biotechnol ...

+Job summaryWe're partnering with a growing Class II medical device company seeking a Director of Quality & Regulatory Affairs to lead Quality and Regulatory strategy as the organization scales. · +Owning and evolving the Quality Management System (21 CFR 820, ISO 13485) · Leadin ...

The Vice President of Regulatory Affairs and Quality Assurance will provide strategic leadership across Regulatory and Quality functions. · This individual will be responsible for developing and executing regulatory and quality strategies that enable efficient advancement of the ...

Provide regulatory support and expertise associated with US and global submission requirements. · Drives projects forward and executes agreed upon strategies and plans with oversight. · Maintains awareness of applicable regulations. · ...

This person will be responsible for the development and execution of global regulatory strategy across the company's clinical portfolio (starting with a late-stage emphasis). This role offers high autonomy, direct ownership of a pivotal submission(s), and the opportunity to lead ...