Jobs
Jobs
35,017 jobs found
Loading more...
J.E. Dunn Construction Company
Superintendent, AFG
Source: National Labor Exchange
J.E. Dunn Construction Company
Project Engineer, AFG
Source: National Labor Exchange
J.E. Dunn Construction Company
Project Engineer, AFG
Source: National Labor Exchange
J.E. Dunn Construction Company
Superintendent, AFG
Source: National Labor Exchange
HPC Industrial
General Manager Data Centers
Source: National Labor Exchange
AutoZone, Inc.
Part Sales Manager - Part Time
Source: National Labor Exchange
AutoZone, Inc.
Part Sales Manager - Part Time
Source: National Labor Exchange
Cengage Group
Manager, Technical Accounting
Source: National Labor Exchange
Cengage Group
Field Sales Consultant, OK
Source: National Labor Exchange
Oracle
Federal Project Manager III - General Readiness
Source: National Labor Exchange
Oracle
Senior Consultant - Health Information Management
Source: National Labor Exchange
PwC
Source-to-pay Technology Consultant (Coupa, ZIP, GEP) Senior Associate
Source: National Labor Exchange
PwC
Oracle Cloud Finance - Director
Source: National Labor Exchange
Highmark Health
Principal Architect
Source: National Labor Exchange
PwC
Source-to-pay Technology Consultant (Coupa, ZIP, GEP) Senior Associate
Source: National Labor Exchange
The Boeing Company
F-15 Project Engineer
Source: National Labor Exchange
Coinbase
Senior Analyst, Compliance Technology
Source: National Labor Exchange
Coinbase
Specialist, Market Operations
Source: National Labor Exchange
Otsuka America Pharmaceutical Inc.
Associate Director, Thought Leader Liaison, Neurology Rare Disease - Central Region
Source: National Labor Exchange
Otsuka America Pharmaceutical Inc.
Director, Market Development & Patient Journey, Rare Neurology
Source: National Labor Exchange
Otsuka America Pharmaceutical Inc.
Director, U.S. Brand Strategy & HCP Engagement, Rare Neurology
Source: National Labor Exchange
Otsuka America Pharmaceutical Inc.
Senior Director, Global Regulatory Strategy
Source: National Labor Exchange
ARCO
Project Coordinator, Concrete
Source: National Labor Exchange
ARCO
Sr Manager, Accounting Systems and Operations
Source: National Labor Exchange
The Hertz Corporation
Driver
Source: National Labor Exchange
The Hertz Corporation
Car Wash Attendant
Source: National Labor Exchange
The Hertz Corporation
Part Time Car Wash Attendant
Source: National Labor Exchange
Amrize
Process Engineer Intern (Summer 2027)
Source: National Labor Exchange
Amrize
Mechanical Engineer Intern (Summer 2027)
Source: National Labor Exchange
DHL Express, Inc.
Field Services Supervisor II
Source: National Labor Exchange
U.S. Bank
Healthcare Payment Sales Consultant
Source: National Labor Exchange
Deloitte
Associate Solution Architect with Modernization Experience
Source: National Labor Exchange
Deloitte
Associate Solution Architect with Modernization Experience
Source: National Labor Exchange
State of Missouri
Building Administrator - Maple Valley
Source: MO Careers
State of Missouri
Hearing Officer
Source: MO Careers
State of Missouri
MSSD - Teacher Aide - Mississippi Valley
Source: MO Careers
State of Missouri
Registered Nurse - EW Thompson School
Source: MO Careers
State of Missouri
Public Information Specialist I - Photography
Source: MO Careers
State of Missouri
Summer Intern - Springfield Planning LPA (Local Public Agency)
Source: MO Careers
State of Missouri
Licensed Clinical Social Worker
Source: MO Careers
Loading more...
Job ID #68023
Otsuka America Pharmaceutical Inc.
Senior Director, Global Regulatory Strategy
location_on
Jefferson City, MO
work_outline
Full-Time
description
Summary
Remote
Full time
R12948
Position Summary
The Senior Director, Global Regulatory Strategy is a senior regulatory executive responsible for providing strategic leadership and oversight for a therapeutic area portfolio of development and marketed products. This role is responsible for leading execution of individual products and portfolio-wide regulatory strategies that enable efficient product development, successful global registrations, and maximized asset value throughout the product lifecycle.
As a member of the Global Regulatory Leadership Team, the Senior Director serves as the regulatory leader for portfolio planning, governance, and risk management activities, ensuring alignment between global regulatory strategy, development priorities, and global business objectives by driving enterprise decision-making, optimizing regulatory pathways, and proactively manage portfolio risks, while building organizational regulatory capabilities.
Key Responsibilities
Regulatory Strategy and Portfolio Leadership
+ Provide strategic leadership for assets in a therapeutic area portfolio, ensuring global regulatory strategies are appropriate across development, registration, commercialization, and lifecycle management activities.
+ Support with establishing an integrated regulatory vision and long-term strategy that supports portfolio objectives, optimizes development pathways, and maximizes each products value globally.
+ Drive individual asset and portfolio-level regulatory decision-making by evaluating benefit-risk profiles, development opportunities, competitive landscapes, and emerging regulatory trends.
+ Identify, assess, and proactively manage regulatory risks and opportunities across assets in the portfolio, recommending mitigation strategies and contingency plans.
+ Ensure appropriate regulatory positions, messaging, and strategic approaches across multiple programs and regions to ensure products with the portfolio align with business objectives.
+ Incorporate regulatory intelligence, health authority precedents, and evolving global requirements into portfolio strategy and investment decisions.
Regulatory Submissions and Lifecycle Management
+ Provide strategic oversight for major global regulatory milestones, including INDs, CTAs, NDAs, BLAs, MAAs, label expansions, and significant post-approval submissions.
+ Ensure regulatory submission strategies support overall asset and portfolio objectives and are aligned with global development plans.
+ Oversee regulatory planning and execution across multiple programs to ensure timely submissions, approvals, and lifecycle deliverables.
+ Guide development of regulatory positions and review critical regulatory documents, agency responses, and submission content for strategic alignment and quality for all submissions
+ Drive global lifecycle management strategies that enhance product value, expand indications, and maintain regulatory compliance.
Health Authority Interactions
+ Establish and oversee global health authority engagement strategies across the therapeutic area portfolio.
+ Lead high-impact agency interactions involving significant regulatory, scientific, or business implications.
+ Serve as the senior regulatory advisor for meetings with global regulatory authorities.
+ Provide strategic direction for briefing packages, regulatory negotiations, and responses to complex agency questions.
+ Foster productive relationships with health authorities to facilitate successful development and registration outcomes.
Cross-Functional and Organizational Leadership
+ Serve as the senior regulatory representative on therapeutic area portfolio governance committees, development leadership teams, and strategic planning forums.
+ Partner with Clinical Development, Medical Affairs, Regulatory CMC, Quality, Safety, Commercial, Market Access, and Program Leadership to drive integrated decision-making.
+ Serve as a Global Regulatory lead as well as leading, developing, and mentoring other Global Regulatory Leads and regulatory team members, creating a high-performing and collaborative regulatory organization.
+ Ensure appropriate resource allocation, succession planning, and capability development across the therapeutic area.
+ Provide regulatory expertise and recommendations to support enterprise decision-making .
+ Champion a culture of accountability, innovation, and operational excellence within the regulatory function.
Compliance and Continuous Improvement
+ Ensure regulatory activities are conducted in compliance with applicable global regulations, company policies, and quality standards.
+ Lead initiatives to enhance regulatory effectiveness, operational efficiency, and organizational performance.
+ Drive development and implementation of regulatory best practices, standards, and governance processes.
+ Promote inspection readiness and a culture of continuous improvement across the organization.
+ Contribute to the evolution of the global regulatory function through strategic initiatives, process optimization, and organizational transformation efforts.
Qualifications
+ Advanced degree in a scientific discipline required; PhD, PharmD, MD, or equivalent preferred.
+ Minimum 15 years of progressive regulatory affairs experience within the pharmaceutical or biotechnology industry.
+ Significant experience developing and leading global regulatory strategies across multiple development and commercial programs.
+ Demonstrated success influencing portfolio-level decisions and achieving regulatory approvals in major global markets.
+ Proven track record leading complex health authority interactions, negotiations, and regulatory risk-management activities.
+ Experience leading and developing high-performing regulatory teams and managing organizational priorities.
+ Strong understanding of portfolio governance, strategic planning, and cross-functional drug development processes.
Knowledge and Skills
+ Expert knowledge of global drug development, regulatory frameworks, and registration requirements across major markets.
+ Demonstrated ability to develop and execute portfolio-level regulatory strategies in a complex global environment.
+ Strong business acumen with the ability to balance regulatory, scientific, operational, and commercial considerations.
+ Expertise in regulatory risk assessment, scenario planning, and strategic decision-making.
+ Exceptional leadership, influencing, negotiation, and stakeholder management skills.
+ Proven ability to operate effectively at executive and governance levels.
+ Strong people leadership capabilities, including organizational development, coaching, and talent management.
+ Excellent communication and presentation skills with experience interacting with senior executives and global health authorities.
+ Ability to lead through complexity, ambiguity, and or...
Full time
R12948
Position Summary
The Senior Director, Global Regulatory Strategy is a senior regulatory executive responsible for providing strategic leadership and oversight for a therapeutic area portfolio of development and marketed products. This role is responsible for leading execution of individual products and portfolio-wide regulatory strategies that enable efficient product development, successful global registrations, and maximized asset value throughout the product lifecycle.
As a member of the Global Regulatory Leadership Team, the Senior Director serves as the regulatory leader for portfolio planning, governance, and risk management activities, ensuring alignment between global regulatory strategy, development priorities, and global business objectives by driving enterprise decision-making, optimizing regulatory pathways, and proactively manage portfolio risks, while building organizational regulatory capabilities.
Key Responsibilities
Regulatory Strategy and Portfolio Leadership
+ Provide strategic leadership for assets in a therapeutic area portfolio, ensuring global regulatory strategies are appropriate across development, registration, commercialization, and lifecycle management activities.
+ Support with establishing an integrated regulatory vision and long-term strategy that supports portfolio objectives, optimizes development pathways, and maximizes each products value globally.
+ Drive individual asset and portfolio-level regulatory decision-making by evaluating benefit-risk profiles, development opportunities, competitive landscapes, and emerging regulatory trends.
+ Identify, assess, and proactively manage regulatory risks and opportunities across assets in the portfolio, recommending mitigation strategies and contingency plans.
+ Ensure appropriate regulatory positions, messaging, and strategic approaches across multiple programs and regions to ensure products with the portfolio align with business objectives.
+ Incorporate regulatory intelligence, health authority precedents, and evolving global requirements into portfolio strategy and investment decisions.
Regulatory Submissions and Lifecycle Management
+ Provide strategic oversight for major global regulatory milestones, including INDs, CTAs, NDAs, BLAs, MAAs, label expansions, and significant post-approval submissions.
+ Ensure regulatory submission strategies support overall asset and portfolio objectives and are aligned with global development plans.
+ Oversee regulatory planning and execution across multiple programs to ensure timely submissions, approvals, and lifecycle deliverables.
+ Guide development of regulatory positions and review critical regulatory documents, agency responses, and submission content for strategic alignment and quality for all submissions
+ Drive global lifecycle management strategies that enhance product value, expand indications, and maintain regulatory compliance.
Health Authority Interactions
+ Establish and oversee global health authority engagement strategies across the therapeutic area portfolio.
+ Lead high-impact agency interactions involving significant regulatory, scientific, or business implications.
+ Serve as the senior regulatory advisor for meetings with global regulatory authorities.
+ Provide strategic direction for briefing packages, regulatory negotiations, and responses to complex agency questions.
+ Foster productive relationships with health authorities to facilitate successful development and registration outcomes.
Cross-Functional and Organizational Leadership
+ Serve as the senior regulatory representative on therapeutic area portfolio governance committees, development leadership teams, and strategic planning forums.
+ Partner with Clinical Development, Medical Affairs, Regulatory CMC, Quality, Safety, Commercial, Market Access, and Program Leadership to drive integrated decision-making.
+ Serve as a Global Regulatory lead as well as leading, developing, and mentoring other Global Regulatory Leads and regulatory team members, creating a high-performing and collaborative regulatory organization.
+ Ensure appropriate resource allocation, succession planning, and capability development across the therapeutic area.
+ Provide regulatory expertise and recommendations to support enterprise decision-making .
+ Champion a culture of accountability, innovation, and operational excellence within the regulatory function.
Compliance and Continuous Improvement
+ Ensure regulatory activities are conducted in compliance with applicable global regulations, company policies, and quality standards.
+ Lead initiatives to enhance regulatory effectiveness, operational efficiency, and organizational performance.
+ Drive development and implementation of regulatory best practices, standards, and governance processes.
+ Promote inspection readiness and a culture of continuous improvement across the organization.
+ Contribute to the evolution of the global regulatory function through strategic initiatives, process optimization, and organizational transformation efforts.
Qualifications
+ Advanced degree in a scientific discipline required; PhD, PharmD, MD, or equivalent preferred.
+ Minimum 15 years of progressive regulatory affairs experience within the pharmaceutical or biotechnology industry.
+ Significant experience developing and leading global regulatory strategies across multiple development and commercial programs.
+ Demonstrated success influencing portfolio-level decisions and achieving regulatory approvals in major global markets.
+ Proven track record leading complex health authority interactions, negotiations, and regulatory risk-management activities.
+ Experience leading and developing high-performing regulatory teams and managing organizational priorities.
+ Strong understanding of portfolio governance, strategic planning, and cross-functional drug development processes.
Knowledge and Skills
+ Expert knowledge of global drug development, regulatory frameworks, and registration requirements across major markets.
+ Demonstrated ability to develop and execute portfolio-level regulatory strategies in a complex global environment.
+ Strong business acumen with the ability to balance regulatory, scientific, operational, and commercial considerations.
+ Expertise in regulatory risk assessment, scenario planning, and strategic decision-making.
+ Exceptional leadership, influencing, negotiation, and stakeholder management skills.
+ Proven ability to operate effectively at executive and governance levels.
+ Strong people leadership capabilities, including organizational development, coaching, and talent management.
+ Excellent communication and presentation skills with experience interacting with senior executives and global health authorities.
+ Ability to lead through complexity, ambiguity, and or...
Do You Have a MO Jobs Account?
Your HireMO account is created from your MO Jobs account, so we need to connect the two.
Already have an account?
Sign In
First, Let's Find Your MO Jobs Account
HireMO works together with MO Jobs, the State of Missouri jobs website.
Create an Account to Apply
Your MO Jobs account is connected. Choose an email and password to sign in to HireMO.
You Need a MO Jobs Account First
HireMO works together with MO Jobs, the State of Missouri jobs website. You need a MO Jobs account before you can create your HireMO account.
- Create your MO Jobs account at jobs.mo.gov. It is free.
- Log in to MO Jobs, then click HireMO from there. That link brings you back here to finish your registration.
- Complete your HireMO account.