Talent.com
Senior/Vice President, Technical (Clinical Regulatory)
Senior/Vice President, Technical (Clinical Regulatory)Parexel • Long Beach, CA, US
[error_messages.no_longer_accepting]
Senior / Vice President, Technical (Clinical Regulatory)

Senior / Vice President, Technical (Clinical Regulatory)

Parexel • Long Beach, CA, US
[job_card.30_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.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.

    [job_alerts.create_a_job]

    President Regulatory • Long Beach, CA, US

    [internal_linking.similar_jobs]
    Clinical Director

    Clinical Director

    SYC • Carson, CA, US
    [job_card.full_time]
    Location : Carson, CA 90746.Job Type : Full-Time 9 : 00 am - 5 : 30 pm with a rotation of on-call hours.The START Model provides prevention and intervention services to people with.IDD) and com...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Senior Vice President Operations

    Senior Vice President Operations

    TH Daniels • Long Beach, CA, US
    [job_card.full_time]
    TH Daniels Global Executive Search & Selection work globally with an established portfolio of clients providing best in class Executive Search results. We have partnered with a large Veterinary ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Vice President, Account Director

    Vice President, Account Director

    Syneos Health / inVentiv Health Commercial LLC • Santa Monica, CA, United States
    [job_card.full_time]
    You are organized, driven, and thrive in a leader position.In this role, you will maintain close relationships while building lasting trust and confidents with multiple accounts.By developing stron...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Director of Antimicrobial Stewardship Clinical Position in Infectious Diseases 2025-2026

    Director of Antimicrobial Stewardship Clinical Position in Infectious Diseases 2025-2026

    University of California - Los Angeles (UCLA) • Los Angeles, CA, United States
    [job_card.full_time]
    Director of Antimicrobial Stewardship .The posted UC salary scales [https : / / www.The salary range for this position is $163,300-$429,000. This position includes membership in the health sciences c...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Regulatory Compliance Director, RN

    Regulatory Compliance Director, RN

    Sunnyside Nursing and Post-Acute Care • Torrance, CA, US
    [job_card.full_time]
    [filters_job_card.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.last_updated_30]
    Executive Director, Chief of Advanced Practice

    Executive Director, Chief of Advanced Practice

    California Staffing • Los Angeles, CA, US
    [job_card.full_time]
    Executive Director, Chief Of Advanced Practice.Ranked among the top 10 pediatric hospitals in the nation, Children's Hospital Los Angeles (CHLA) provides the best care for kids in California.Here, ...[show_more]
    [last_updated.last_updated_variable_hours] • [promoted] • [new]
    Senior Vice President, Regulatory Strategy

    Senior Vice President, Regulatory Strategy

    VirtualVocations • Long Beach, California, United States
    [job_card.full_time]
    A company is looking for a Senior Vice President, Regulatory and Product Strategy.Key Responsibilities Lead integrated Regulatory Strategy, Regulatory Affairs, Commercial Strategy, and Clinical D...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Senior Vice President, Regional Director - RIA | Bank Group

    Senior Vice President, Regional Director - RIA | Bank Group

    Aristotle Capital Management, LLC • Los Angeles, CA, United States
    [job_card.full_time]
    Aristotle is a majority employee-owned investment management organization with offices in Los Angeles, Newport Beach, Boston, and Sarasota. We specialize in equity and fixed income portfolio managem...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Senior Vice President, Strategy Lead

    Senior Vice President, Strategy Lead

    Syneos Health / inVentiv Health Commercial LLC • Santa Monica, CA, United States
    [job_card.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.last_updated_30] • [promoted]
    Vice President, Program Management Pharma

    Vice President, Program Management Pharma

    Varda Space Industries • El Segundo, California, USA
    [job_card.full_time] +1
    Low Earth orbit is open for business.Varda is accelerating the development of commercial space infrastructure from in-orbit pharmaceutical processing to reliable and economical reentry capsules.Fro...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Senior Director of Regulatory Operations

    Senior Director of Regulatory Operations

    VirtualVocations • Carson, California, United States
    [job_card.full_time]
    A company is looking for a Senior Director, Regulatory Operations - Phase 1 Oncology Site.Key Responsibilities Build and manage scalable regulatory operations processes for Phase 1 oncology studi...[show_more]
    [last_updated.last_updated_1_hour] • [promoted] • [new]
    Director, Clinical Pharmacy

    Director, Clinical Pharmacy

    CareMore Health • Long Beach, CA, US
    [job_card.full_time]
    CareMore Health is a physician-founded and physician-led organization that has been transforming care delivery since 1992. With 25 clinics, 65,000+ members and partnerships with 30+ health plans, we...[show_more]
    [last_updated.last_updated_variable_days] • [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
    [job_card.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.last_updated_variable_days] • [promoted]
    Director of Antimicrobial Stewardship Clinical Position in Infectious Diseases

    Director of Antimicrobial Stewardship Clinical Position in Infectious Diseases

    University of California - Los Angeles (UCLA) • Los Angeles, CA, United States
    [job_card.full_time]
    Director of Antimicrobial Stewardship.The posted UC salary scales [] set the minimum pay determined by rank and step at appointment. See Table 5 [] The salary range for this position is $163,300-$42...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Vice President, Partnerships

    Vice President, Partnerships

    ChowNow • Long Beach, CA, US
    [job_card.full_time]
    Are you excited by the opportunity to help local restaurants thrive? Do you love the challenge of building strategic partnerships, unlocking new revenue channels, and scaling what's working? If for...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Regional Vice President

    Regional Vice President

    JAS Worldwide • Los Angeles, CA, US
    [job_card.full_time]
    JAS is an international, non-asset-based supply chain services and solutions company.Our services include air and ocean freight forwarding, contract logistics, customs brokerage, distribution, inbo...[show_more]
    [last_updated.last_updated_variable_hours] • [promoted] • [new]
    Senior Vice President, Strategy Lead

    Senior Vice President, Strategy Lead

    Syneos Health • Santa Monica, CA, United States
    [job_card.full_time]
    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 scientific insights into a strategic point ...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Clinical Trials Regulatory Coordinator - Urology

    Clinical Trials Regulatory Coordinator - Urology

    University of California - Los Angeles Health • Los Angeles, CA, United States
    [job_card.full_time]
    Under the direct supervision of the Clinical Trials Administrator, The Regulatory Coordinator is responsible for submitting and managing all regulatory documentation for the Institute of Urologic O...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]