Talent.com
Senior/Vice President, Technical (Clinical Regulatory)
Senior/Vice President, Technical (Clinical Regulatory)Parexel • Long Beach, CA, US
No longer accepting applications
Senior / Vice President, Technical (Clinical Regulatory)

Senior / Vice President, Technical (Clinical Regulatory)

Parexel • Long Beach, CA, US
21 days ago
Job type
  • Full-time
Job description

Senior / Vice President Technical, Regulatory Strategy

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

At Parexel, we don't just support drug developmentwe help shape it. As a Senior / Vice President, Technical on our Regulatory Strategy (RS) team, you'll be at the forefront of innovation, guiding biopharma companies through complex regulatory landscapes to bring safer, more effective therapies to patients worldwide.

You will :

  • Lead strategic regulatory initiatives across diverse product types and global markets
  • Advise clients throughout the product lifecycle, from early development to post-marketing
  • Share your scientific, technical, and commercial expertise to influence regulatory outcomes
  • Collaborate with and lead teams of respected subject matter experts
  • Represent Parexel as a visible thought leader in the industry
  • Meet new situations and learn all the time. In fact, one of the key characteristics you'll see in our Sr / VP Techs is innate curiosity along with a passion for the science, the industry, and public health. If you're committed to public health and want to make a difference, this is the ideal role. We're currently seeking a highly experienced Clinical Regulatory Leader, Health Authority Medical Review Team Lead, Master / Senior Medical Review Officer who is looking to draw upon their wealth of experience in clinical trial design and drug development to join Parexel's highly recognized Regulatory Strategy team!

A Senior / Vice President Technical must be an internationally recognized professional in their field of expertise with fully proven rainmaking skills and relationships at the most senior levels within client organizations. A Senior / Vice President Technical must have a thorough understanding of the organization's consulting models and methodologies, as well as extensive knowledge of what services RS provides. A Senior / Vice President Technical provides a full range of consulting services and works within their personal area of expertise. A Senior / Vice President Technical provides mentoring and guidance to other RS employees and leads knowledge-centered activities within RS. A Senior / Vice President Technical participates in the development of new service offerings, consulting models and methodologies.

Project Execution

  • Works within a team environment or individually based on project needs
  • Works within broad project guidelines and leads issue and conflict resolution
  • Prioritizes own workload and prioritizes the workload of the project team to achieve the project scope and objectives
  • Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action
  • Leverages information from previous projects or other client work to efficiently complete assigned project activities as well as facilitate business decisions
  • Produces quality work that meets the expectations of RS and the client. Reviews the work of colleagues for content and quality to ensure the expectations of the client and RS are met
  • Manages project engagements (small or large)
  • Interacts with the assigned Project Assistant to ensure accurate financial management and for general project support
  • Provides guidance to project team members and acts as a mentor to junior staff
  • Thought Leadership

  • Frequently presents speeches or seminars to industry groups based on recognized expertise in his / her field
  • Frequently authors articles for publication in industry magazines, newsletters, book chapters and other forums
  • Reviews the thought leadership activities (presentations, articles) of colleagues for content and quality to ensure the expectations of RS are met
  • Regularly quoted by general and industry news outlets
  • When applicable, serves as a leading member of industry association boards, task forces and committees and / or as chairperson or officer of one or more professional associations
  • Contributes expertise to professional societies, academic or other similar groups influential in his / her area of expertise
  • Reinforces the knowledge-centered activities within RS based on their own knowledge and expertise
  • Facilitates improvements to Parexel business processes
  • Facilitates new service and consulting model development
  • Consulting Activities and Relationship Management

  • Adapts the appropriate organization's consulting models and methodologies when unique situations present themselves as well as designs / improves the methodologies when needed
  • Provides a full range of technical and / or business consulting services across multiple disciplines of services including representing clients to regulatory agencies
  • Completes and delegates project activities in a timely manner with an understanding of issues which may impact project profitability and client satisfaction
  • Acts as a trusted advisor to clients, often on issues that lack precedent or are not clearly defined
  • Acts as a loaned executive for a client when required
  • Facilitates resolutions to possible problems or conflicts within the project team and / or the client
  • Provides guidance as needed to lower-level colleagues on appropriate methods of executing project activities
  • Develops and implements business solutions addressing specific client needs using expertise, best practices and knowledge of the client's business and key industry drivers
  • Demonstrated ability to interact professionally at multiple levels including senior and executive management within a client organization. Presents to client boards and provide strategic advice to the C suite
  • Plans and delivers services and solutions which results in clients expressing satisfaction with service provided and build relationships which results in additional business or referrals
  • Identifies opportunities for follow-on business or changes in project scope and exploits the opportunities with RS management and account management
  • Requirements

  • Education - MD required
  • Minimum Work Experience - 15+ years experience with expert level industry or regulatory knowledge experience in Clinical Development / Clinical Trial Design, Clinical Strategy, and expertise in reviewing and evaluating clinical sections of regulatory applications.
  • Previous experience with a regulatory agency (such as the FDA or MHRA) as a Senior / Master Medical Review Officer, Team Lead, etc. or a related medical role is required. Depth of experience will be considered when determining the level of Senior Vice President Technical or Vice President Technical
  • Extensive Endocrinology, Neuroscience, Rare Disease, or Immunology experience is required.
  • The ability to travel up to 20-30% domestically and / or internationally may be required for Client and / or Health Authority Meetings and Thought Leadership / Conference Attendance
  • EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

    Create a job alert for this search

    President Regulatory • Long Beach, CA, US

    Related jobs
    Vice President, Concepts Lab

    Vice President, Concepts Lab

    Crunchyroll • Los Angeles, CA, US
    Full-time
    Founded by fans, Crunchyroll delivers the art and culture of anime to a passionate community.We super-serve over 100 million anime and manga fans across 200+ countries and territories, and help the...Show more
    Last updated: 15 days ago • Promoted
    Vice President, Technical Project Manager

    Vice President, Technical Project Manager

    Oaktree Capital Management • Los Angeles, CA, US
    Full-time
    Oaktree is a leader among global investment managers specializing in alternative investments, with over $200 billion in assets under management. The firm emphasizes an opportunistic, value-oriented ...Show more
    Last updated: 22 days ago • Promoted
    Senior Director, Global Commercial Strategy, Lymphoma

    Senior Director, Global Commercial Strategy, Lymphoma

    Gilead Sciences, Inc. • Santa Monica, CA, United States
    Full-time
    We’re here for one reason and one reason only — to cure cancer.Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scienti...Show more
    Last updated: 21 days ago • Promoted
    Senior Vice President, Strategy Lead

    Senior Vice President, Strategy Lead

    Syneos Health • Santa Monica, CA, US
    Full-time
    Updated : October 2, 2025 Location : Santa Monica, CA, United States The SVP Strategy Lead is able to work and balance all sides of the agency / client relationship by translating customer and scient...Show more
    Last updated: 8 days ago • Promoted
    Regulatory Compliance Director, RN

    Regulatory Compliance Director, RN

    Sunnyside Nursing and Post-Acute Care • Torrance, CA, US
    Full-time
    Quick Apply
    Director of Regulatory Compliance (RN).Location : Sunnyside Nursing & Post-Acute Care – Torrance, CA.Sunnyside Nursing & Post-Acute Care is seeking a skilled Director of Regulatory Comp...Show more
    Last updated: 30+ days ago
    President

    President

    Computrition • Long Beach, CA, US
    Full-time
    Computrition is a market-leading provider of software and services that optimize foodservice, nutrition, and retail operations across healthcare, long-term care, higher education, and other institu...Show more
    Last updated: 4 days ago • Promoted
    Senior Vice President, Strategy Lead

    Senior Vice President, Strategy Lead

    Syneos Health / inVentiv Health Commercial LLC • Santa Monica, CA, United States
    Full-time
    The SVP Strategy Lead is able to work and balance all sides of the agency / client relationship by translating customer and scientific insights into a strategic point of view that can ground a team, ...Show more
    Last updated: 24 days ago • Promoted
    Senior Director, Strategy & Operations

    Senior Director, Strategy & Operations

    Mosaic Health • Long Beach, CA, US
    Full-time
    Senior Director, Strategy & Operations.The Senior Director, Strategy & Operations will be responsible for driving enterprise-wide strategic planning, operational excellence, and critical initiative...Show more
    Last updated: 20 days ago • Promoted
    Vice President Compliance and Regulatory Affairs

    Vice President Compliance and Regulatory Affairs

    Belmont Village Lp • Los Angeles, CA, United States
    Full-time
    Vice President of Compliance and Regulatory Affairs.Assisted Living and Memory Care communities across multiple states.This strategic leader ensures adherence to federal, state, and local regulatio...Show more
    Last updated: 30+ days ago • Promoted
    Senior Director, Global Clinical Development Nephrology & Immunology

    Senior Director, Global Clinical Development Nephrology & Immunology

    Otsuka Pharmaceutical • Long Beach, CA, US
    Full-time
    Senior Director, Global Clinical Development (GCD).Otsuka is seeking an experienced and visionary Senior Director, Global Clinical Development (GCD), with experience in immunology, who will serve a...Show more
    Last updated: 6 days ago • Promoted
    VP, Client Manager, Life Sciences

    VP, Client Manager, Life Sciences

    USA Jobs • Los Angeles, CA, US
    Full-time
    Los Angeles with one wholly-owned banking subsidiary, Banc of California.Banc of California is one of the nation's premier relationship-based business banks focused on providing banking and treasur...Show more
    Last updated: 8 hours ago • Promoted • New!
    Vice President, Client Experience - Healthcare

    Vice President, Client Experience - Healthcare

    Circa Labs • Los Angeles, CA, US
    Full-time
    Vice President, Client Experience - Healthcare.We are seeking a strong Vice President to join our West Coast Healthcare Practice with offices in Los Angeles, San Francisco and Seattle.The Vice Pres...Show more
    Last updated: 30+ days ago • Promoted
    Regulatory and Clinical LeadLos Angeles, California

    Regulatory and Clinical LeadLos Angeles, California

    Horizon Surgical Systems • Los Angeles, CA, US
    Full-time
    AI driven, and imaging-guided surgical robotic system.Microsurgery in general and Ophthalmology are subfields of surgery for which the surgical outcomes can be significantly improved by robotic sys...Show more
    Last updated: 30+ days ago • Promoted
    Regional Vice President, Network Performance

    Regional Vice President, Network Performance

    Humana • Los Angeles, CA, US
    Full-time
    Regional VP, Network Performance.The Regional VP, Network Performance manages the development, operations, and results of a health plan. The Regional VP requires an in-depth understanding of how org...Show more
    Last updated: 10 days ago • Promoted
    Associate Vice President, Conflicts Management and Trade Surveillance Compliance

    Associate Vice President, Conflicts Management and Trade Surveillance Compliance

    Ares Management Corporation • Los Angeles, CA, United States
    Full-time
    Associate Vice President, Conflicts Management and Trade Surveillance Compliance.The Ares Compliance Department oversees and manages Ares’ global regulatory compliance and ethics program.Under the ...Show more
    Last updated: 8 days ago • Promoted
    Senior Director, Compensation

    Senior Director, Compensation

    VCA Animal Hospitals • Los Angeles, CA, US
    Full-time
    Director, Compensation role is responsible for compensation and rewards strategy and execution for VCA in collaboration and alignment with Mars Veterinary Health Total Rewards team and policies.The...Show more
    Last updated: 30+ days ago • Promoted
    Vice President, Client Experience - Healthcare

    Vice President, Client Experience - Healthcare

    IPG DXTRA • Los Angeles, CA, US
    Full-time
    Vice President, Client Experience - Healthcare.We are seeking a strong Vice President to join our West Coast Healthcare Practice with offices in Los Angeles, San Francisco and Seattle.The Vice Pres...Show more
    Last updated: 30+ days ago • Promoted
    Regional Vice President, Health Plan Sales

    Regional Vice President, Health Plan Sales

    Headspace • Santa Monica, CA, US
    Full-time
    Regional Vice President, Health Plan Sales About the Regional Vice President, Health Plan Sales.The Regional Vice President (RVP), Health Plan Sales sits on our Health Plan Sales team, which focuse...Show more
    Last updated: 10 days ago • Promoted