Regulatory Strategy Manager

$132.7k - $182k

Neurocrine Biosciences

San Diego, CA

Responsibilities

Develop, review, and file regulatory submissions including INDs, CTAs, DSURs, and annual reports
Collaborate on global regulatory strategies supporting CMC, nonclinical, and clinical development programs
Conduct regulatory intelligence research on competitive products and communicate emerging regulations to stakeholders
Review clinical study documentation including protocols, informed consent forms, and recruitment materials
Lead and coordinate preparation of regulatory filing documents with cross-functional project teams

Requirements

Bachelor's degree in life or health sciences plus 6+ years industry experience with minimum 3 years in regulatory affairs at research-based pharmaceutical company
Master's degree in life or health sciences with 4+ years related experience, or PharmD/PhD with 2+ years experience
Two years leading regulatory affairs in drug development
Knowledge of FDA regulations and ICH guidelines for regulatory submissions
Strong project management, verbal and written communication skills
Ability to work independently and lead cross-functional teams with minimal direction
Proficiency with computer systems and excellent analytical thinking abilities

Compensation: $132,700-$182,000 base salary

Apply

Vacancy posted 24 days ago

Similar jobs that could be interesting for youBased on the Regulatory Strategy Manager in San Diego, CA vacancy

Senior Regulatory Strategy Manager
$158.1k - $216k
...Senior Regulatory Strategy Manager role at a biopharmaceutical company focused on neurological and psychiatric disorders. Leads regulatory strategy, oversees submission preparation, manages cross-functional teams, and ensures compliance with FDA and international regulations...
Suggested
Neurocrine Biosciences
San Diego, CA
15 days ago
Manager, Regulatory Affairs Strategy
$116k - $151k
...science and service for rare patients.Position Summary:The Manager, Regulatory Affairs provides regulatory leadership and execution support... ...and contributes to the implementation of global regulatory strategies from development through registration and lifecycle...
Suggested
Full time
Contract work
Temporary work
Remote work
Travere Therapeutics
San Diego, CA
3 days ago
Associate Director, Regulatory Labeling Strategy (San Diego or Remote)
...comPosition Summary:The Associate Director, Labeling Strategy is responsible for developing and executing global regulatory labeling strategies throughout the product... ...and patients.Independently authors and manages communications regarding CCDS and labeling updates...
Suggested
Local area
Remote work
Planet Pharma
San Diego, CA
4 days ago
Strategy Manager
$136.25k - $180k
...Work Schedule: Days, 8-Hour Shifts , Monday - Friday #141656 Strategy Manager Filing Deadline: Mon 10/12/2026 UC San Diego values and... ...optimization, operational efficiency, shared services, regulatory risk reduction, improved resource utilization, infrastructure...
Suggested
Hourly pay
Contract work
Local area
Monday to Friday
Day shift
University of California San Diego
San Diego, CA
1 day ago
Executive Director, Regulatory Strategy
...Executive Director, Regulatory Strategy About the Company Clinical-stage biopharmaceutical company developing innovative, transformational medicines. Industry Biotechnology Type Privately Held About the Role The Company is seeking an Executive Director...
Suggested
Confidential
San Diego, CA
3 days ago
Executive Director Regulatory Affairs Strategy
...Top Echelon. About the Role: The Executive Director, Regulatory Strategy – Endocrinology is a senior regulatory leader responsible for... ...from first-in-human through post-marketing lifecycle management Provides guidance on complex regulatory issues to cross-...
Clinical Dynamix, Inc.
San Diego, CA
7 days ago
Technology Strategy Manager/Sr Manager: Communications, Media and High Tech
$87.4k - $253k
...Technology Strategy Manager/Sr. Manager, Communications, Media & High-Tech Industry Technology Strategy, and we design and execute industry-relevant reinventions that allow organizations to realize exceptional business value from technology. Our vision is to become...
Live in
Work at office
Local area
Accenture
San Diego, CA
2 days ago
Regulatory Affairs Manager
$140k - $150k
...Zimmer Biomet Regulatory Affairs RoleAt Zimmer Biomet, we believe in pushing the boundaries... ...teams to develop and execute regulatory strategies that support business objectives while ensuring... ...and guidance changes.Monitor and manage surveillance of evolving regulations, standards...
Work at office
Flexible hours
Zimmer Biomet
San Diego, CA
1 day ago
Content Strategy & Production Manager
$120k - $175k
Content Strategy & Production ManagerCooley is seeking a Content Strategy & Production Manager to join the Marketing and Client Development team.About Cooley: Cooley is a global law firm with an expansive practice and more than 3,000 employees and partners worldwide. We...
Full time
Contract work
Temporary work
Freelance
Work at office
Immediate start
Remote work
Work from home
Worldwide
Flexible hours
Weekend work
Cooley
San Diego, CA
2 days ago
Technology Strategy Manager/Sr Manager: Communications, Media and High Tech
...Technology Strategy Manager/Sr. ManagerTechnology Strategy, and we design and execute industry-relevant reinventions that allow organizations to realize exceptional business value from technology. Our vision is to become the world's leading advisors in harnessing technology...
Work at office
Local area
Accenture
San Diego, CA
3 days ago
Executive Strategy Manager, Healthcare Campus
...UC San Diego Health is seeking a Strategy Manager to serve as a strategic advisor to the Chief Administrative Officer of Health Campus Development. The role translates complex priorities into defined strategies, financially substantiated plans, and accountable execution...
Jobleads-US
San Diego, CA
1 day ago
Regulatory Project Manager
...We're seeking an experienced Project Manager to lead regulatory documentation and compliance-focused initiatives supporting clinical diagnostic products. This role will partner closely with Regulatory Affairs, R&D, Quality, Manufacturing, Medical Affairs, and Marketing...
Full time
Insight Global
San Diego, CA
1 day ago
Regulatory Affairs Manager
$145k - $165k
...California. Job Description We are seeking a motivated Regulatory Affairs professional to join our team and help advance the... ...internal and CRO teams to ensure optimal execution. # Develop, manage and track regulatory submission timelines. # Collaborate...
Odd job
Full time
H1b
Work at office
ORIC Pharmaceuticals
San Diego, CA
1 day ago
Privacy & Compliance Program Manager
$119.75k - $201.95k
...role is to provide analysis, guidance, and direction for the management and resolution of corporate compliance and privacy-related matters... ...administration, compliance risk assessments, data management, regulatory change management, compliance training, team member awareness,...
Full time
Contract work
Work at office
Local area
ICW Group
San Diego, CA
3 days ago
Strategic Deployment Manager, Life Science
$100k - $160k
We’re looking to hire a Strategic Deployment Manager to join us in our mission to improve human health and quality of life through the... ...these customers, you’ll also help drive future product development strategy.Click here for more information about how the Schrödinger...
Work at office
Flexible hours
Schrödinger
San Diego, CA
1 day ago
Director of AI Strategy, Architecture and Solutions
$205.1k - $307.7k
...LocationSan Diego, CA. Not a remote role.Position SummaryThe Director, Strategy, Architecture and Solutions owns the front half of the... ...Experience (UX/UI).This is a leadership role, not a project management role. Success is measured by the quality of the portfolio entering...
Full time
Local area
Illumina
San Diego, CA
14 hours ago
Head of strategy business management
$220k - $250k
...litigation and dispute resolution, world-class regulatory compliance and advisory services, and... ...peers.The Director, Strategic Vendor Management is responsible for the strategic... ...service delivery, and long-term vendor strategy.What You Will Do:Strategic Vendor OwnershipServe...
Full time
Contract work
Work at office
Local area
Goodwin Procter
San Diego, CA
2 days ago
Senior Director, Corporate Strategy (San Diego / Hybrid)
$224.9k - $337.3k
...Status: ExemptPosition Summary:The Senior Director, Corporate Strategy is a senior member of the Enterprise Strategy team who leads some... ...is a people-leader role. The Senior Director manages and develops senior strategy professionals and leads multi-level...
Full time
Work at office
Local area
Relocation package
Monday to Friday
2 days per week
3 days per week
Illumina
San Diego, CA
1 day ago
Strategic Collaborations Senior Manager
$113.3k - $226.7k
...medicines. Our 122,000 colleagues serve people in more than 160 countries. Position Overview The Strategic Collaborations Senior Manager supports strategic clinical collaboration studies activities that enable the adoption of new and emerging technologies and the...
Full time
Contract work
Part time
Work visa
Night shift
Abbott
San Diego, CA
1 day ago
Sr. Manager, Planning Process Improvement & Digitalization
$141.6k - $212.4k
...as well as SAP ECC (S/4).Intake, assess, prioritize, and execute improvement initiatives identified by operational Planning teams. Manage and report status to leaders and requestors.Team ManagementManage and inspire a team of process experts driving Planning process excellence...
Full time
Local area
Illumina
San Diego, CA
2 days ago
Manager or Senior Manager, Strategic Corporate Tax
$153.43k - $332.7k
...in our culture because it is an investment in our people, our future, and what we stand for as a firm.KPMG is currently seeking a Manager or Senior Manager to join our Business Tax Services practice. Responsibilities:Provide tax compliance and advisory services to corporations...
Local area
KPMG
San Diego, CA
3 days ago
Manager of Health Plan Contracting
...The Manager of Health Plan Contracting is responsible for leading all aspects of insurance contract negotiations for the health center... ...for credentialing and contracting functions annually or as regulatory changes require; present updates to leadership and the Governing...
Full time
Contract work
Work at office
Local area
San Diego Community Health Center
San Diego, CA
14 hours ago
Director of Finance & Strategic Planning
$150k - $170k
...them begins with a thoughtful financial strategy. If your idea of finance is simply closing... ...build a company rather than simply managing one. We Think You'll Thrive Here If... ...applicable FINRA registrations or other regulatory qualifications as the company's consumer...
Full time
Remote work
Kaylus
San Diego, CA
4 days ago
Manager, User Guide Strategy and Operations (Hybrid-Acton, MA or San Diego, CA)
$144.5k - $216.8k
Job SummaryThe Manager, User Guide Strategy and Operations serves as a senior leader within the user guide function and is responsible for portfolio... ...cross-functional leaders to support product releases, regulatory submissions, commercial launches, and long-term content...
Full time
Contract work
Work at office
Remote work
3 days per week
Insulet Corporation
San Diego, CA
14 hours ago
Area Water and Wastewater Utility Planning Lead
...Group, you’ll help shape how communities manage water for generations to come. From... ...Business Group marketing staff to develop a strategy to capture key types of projects.Works with... ...resource planning, water and wastewater regulatory compliance and technical support,...
Work at office
Local area
HDR
San Diego, CA
1 day ago
Senior Director, Strategic Program Leadership
...Qualcomm Technologies, Inc. is seeking an experienced Program Manager to lead large-scale programs from initiation to delivery. You will... ...stakeholders to align with product roadmaps and organizational strategy. The role requires a strong background in program management...
Jobleads-US
San Diego, CA
5 days ago
Director of Regulatory Labeling
...Director, Regulatory Affairs (Labeling) *This position can be onsite in Pasadena, CA or San Diego, CA* The Position... ...development and execution of global regulatory labeling strategy. This individual will manage regulatory labeling through all phases of development and...
Full time
ALKU
San Diego, CA
1 day ago
Director, Regulatory Affairs (Global Regulatory Advertising and Promotion)
...Director, Regulatory Affairs (Global Regulatory Advertising and Promotion) *This position... ...advise cross-functional teams on promotional strategy, claims development, fair balance,... ...substantiation requirements, and risk mitigation. Manage all submissions to FDA Office of...
Full time
Work at office
Local area
ALKU
San Diego, CA
1 day ago
Senior Director Regulatory Affairs
...Senior Director, Regulatory Affairs (fully on-site in San Diego) Summary Our client is... ...The Senior Director will own regulatory strategy for new platform development, oversee ongoing... ...and product updates Author and manage IDE, PMA, and PMA supplement submissions...
Full time
BioTalent
San Diego, CA
1 day ago
Director, Regulatory Strategy
$187.2k - $255k
...Neurocrine Biosciences seeks a Director of Regulatory Strategy to lead regulatory activities for development products across preclinical... ...regulatory authorities Provide strategic regulatory guidance to management and cross-functional project teams on development planning...
Neurocrine Biosciences
San Diego, CA
15 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Regulatory Strategy Manager. Be the first to apply!