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Senior Director / Executive Director, US Regulatory Strategy

VCLSSan Francisco, CA
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Overview

Schedule
Full-time
Career level
Executive
Remote
On-site
Benefits
Career Development

Job Description

We are seeking an experienced and commercially minded Senior Director or Executive Director of US Regulatory Strategy to join our growing regulatory consulting organization. This is a high-impact leadership role focused on providing strategic regulatory guidance to biotechnology and pharmaceutical clients developing innovative and complex therapies. The successful candidate will serve as a trusted strategic advisor to clients pursuing late-stage development and commercialization of complex biologics, such as combination products, with a particular emphasis on US FDA regulatory strategy through BLA submission and approval. Experience supporting cell and gene therapies is highly desirable. In addition to technical regulatory leadership, this role requires strong client-facing skills, business acumen, and the ability to contribute to the growth of a boutique consultancy through thought leadership, client development, and industry engagement. 

Key Responsibilities 

Regulatory Strategy Leadership 

  • Lead development and execution of US and global regulatory strategy for clients across all stages of development, with emphasis on late-stage development, registration, and lifecycle management. 
  • Serve as regulatory lead for ADCs, bispecific/trispecific antibodies, combination products, and other complex biologics. 
  • Provide guidance on BLA strategy, expedited pathways, regulatory risk assessment, CMC, nonclinical and clinical requirements, labeling, and post-approval strategy. 
  • Lead all aspects of health authority interactions
  • Support regulatory due diligence activities. 
  • Experience with EMA and other international health authorities is highly valued. 
    • Client Leadership and Consulting 
  • Serve as a senior strategic advisor and primary client contact. 
  • Build long-term biotech and pharmaceutical client relationships. 
  • Lead multidisciplinary consulting teams and mentor junior staff. 
  • Deliver high-quality regulatory recommendations, reports, and presentations. 
    • Business Development and Growth 
  • Support business development, proposals, and client pitches. 
  • Represent the organization at conferences and industry events. 
  • Develop thought leadership materials and support company growth. 

    Requirements

    Required Qualifications 

  • Degree in a life sciences discipline 

    • • Significant industry experience 

    • Deep expertise in US FDA regulatory strategy for biologics. 

    • Multiple successful BLA experiences with direct FDA interactions. 

    • Significant experience with complex modalities, such as combination products and cell and gene therapies 

    • Strong consulting, leadership, communication, and presentation skills. 

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    FAQs About Senior Director / Executive Director, US Regulatory Strategy Jobs at VCLS

    What is the work location for this position at VCLS?
    This job at VCLS is located in San Francisco, CA, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
    What pay range can candidates expect for this role at VCLS?
    Employer has not shared pay details for this role.
    What employment applies to this position at VCLS?
    VCLS lists this role as a Full-time position.
    What experience level is required for this role at VCLS?
    VCLS is looking for a candidate with "Executive" experience level.
    What benefits are offered by VCLS for this role?
    VCLS offers Career Development for this position. Actual benefits may vary depending on the employer's policies and employment terms.
    What is the process to apply for this position at VCLS?
    You can apply for this role at VCLS either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.