Senior Director – US Regulatory Strategy

Voisin Consulting Life Sciences (VCLS)

Senior Director/Executive Director leading US Regulatory Strategy for biotechnology and pharmaceutical clients. Focus on strategic guidance for late-stage development and commercialization of complex therapies.

Posted 6/30/2026full-timeRemote • California, Massachusetts • 🇺🇸 United StatesSeniorWebsite

About the role

Key responsibilities & impact

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.
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.
Support business development, proposals, and client pitches.
Represent the organization at conferences and industry events.
Develop thought leadership materials and support company growth.

Requirements

What you’ll need

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.

Benefits

Comp & perks

🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account Voisin Consulting Life Sciences (VCLS) Website LinkedIn All Job Openings 201 - 500 employees From discovery to product launch and lifecycle managementAt VCLS (Voisin Consulting Life Sciences), regulatory science guides Biotechnology, Pharmaceutical and Medtech manufacturers throughout product development and commercialization. Starting early in the process, from discovery to the patient, VCLS assists innovators in designing optimized product development plans and regulatory strategies, combining the health ecosystem with commercial success. With a presence in seven locations across three continents and over 200 employees, VCLS serves a broad range of healthtech developers and their investors.Together, we accompany global stakeholders to expedite HealthTech products from discovery to patient access and beyond by bridging Science to Regulatory and Market Access strategies. Senior Director – US Regulatory Strategy 🔥 0 minutes ago 🏄 California, Massachusetts – Remote ⏰ Full Time 🟠 Senior 🚔 Compliance Apply Now Find Hiring Managers Customize resume + cover letter Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 Description
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.
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.
Support business development, proposals, and client pitches.
Represent the organization at conferences and industry events.
Develop thought leadership materials and support company growth. 🎯 Requirements
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. Apply Now 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score Similar Jobs Solution Executive, Quality & Compliance 🔥 1 hour ago HealthStream 501 - 1000 ☁️ SaaS 📚 Education 👥 HR Tech Website LinkedIn All Job Openings Solution Executive delivering compliance solutions and aligning courseware with clients' needs for HealthStream. Building relationships with key stakeholders and exceeding sales quotas in healthcare software. 🇺🇸 United States – Remote 💵 $55.7k - $70k / year ⏰ Full Time 🟡 Mid-level 🟠 Senior 🚔 Compliance 🦅 H1B Visa Sponsor Privacy and Compliance Lead 🔥 1 hour ago GetInsured 201 - 500 ☁️ SaaS ⚕️ Healthcare Insurance 🏛️ Government Website LinkedIn All Job Openings Privacy and Compliance Lead overseeing compliance across audits and regulations at VIMO. Leading external audits, developing compliance policies, and analyzing operational compliance. 🇺🇸 United States – Remote 💵 $130k - $165k / year ⏰ Full Time 🟠 Senior 🚔 Compliance 🦅 H1B Visa Sponsor Compliance Coordinator 🔥 4 hours ago Pediatric Home Service 1001 - 5000 ⚕️ Healthcare Insurance Website LinkedIn All Job Openings Compliance Coordinator ensuring adherence to healthcare payer requirements. Joining Pediatric Home Service to support compliance in pediatric home care services across the U.S. 🇺🇸 United States – Remote 💵 $30 / hour ⏰ Full Time 🟠 Senior 🔴 Lead 🚔 Compliance Compliance Coordinator 🔥 4 hours ago Pediatric Home Service 1001 - 5000 ⚕️ Healthcare Insurance Website LinkedIn All Job Openings Compliance Coordinator ensuring adherence to healthcare regulations at Pediatric Home Service. Auditing, policy maintenance, and team collaboration for compliance improvements. 🇺🇸 United States – Remote 💵 $30 / hour ⏰ Full Time 🟠 Senior 🔴 Lead 🚔 Compliance Compliance Coordinator 🔥 4 hours ago Pediatric Home Service 1001 - 5000 ⚕️ Healthcare Insurance Website LinkedIn All Job Openings Compliance Coordinator in pediatric home health care ensuring compliance with government and commercial payer requirements. Auditing documentation, analyzing contracts, and training internal teams. 🇺🇸 United States – Remote 💵 $30 / hour ⏰ Full Time 🟠 Senior 🔴 Lead 🚔 Compliance View More Compliance Jobs 🌐 Worldwide Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com Search Search Jobs by country Search jobs by city Search jobs by job title Search entry-level jobs Search junior-level jobs Search senior-level jobs Search jobs by tech stack Search jobs by contract type Search remote internships Search remote part-time jobs Remote jobs Anywhere in the World Companies Hiring Anywhere in the World Companies Hiring Sales People Anywhere in the World Companies Hiring Software Engineers Anywhere in the World Resources Advice Tips for finding remote jobs Interview questions and answers Resume examples Cover letter examples Post a job Affiliates Privacy policy Terms of service Job board SEO course AI Apply Copilot OpenClaw job finder Jobs by Country Remote jobs anywhere in the world (Worldwide remote jobs) Remote jobs United States Remote jobs Australia Remote jobs Brazil Remote jobs Canada Remote jobs France Remote jobs Ireland Remote jobs Germany Remote jobs Netherlands Remote jobs Spain Remote jobs UK Popular Jobs Remote data analyst jobs Remote customer support jobs Remote executive assistant jobs Remote marketing jobs Remote product designer jobs Remote product manager jobs Remote project manager jobs Remote recruiter jobs Remote sales jobs Remote software engineer jobs Jobs by Type Remote full-time jobs Remote part-time jobs Remote contract jobs Remote internship jobs Remote entry-level jobs Remote jobs with no experience required Remote junior jobs (1-3 years of experience) Digital nomad jobs Remote jobs with no degree required Freelance remote jobs Temporary remote jobs Remote jobs hiring now Stay at home mom jobs

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Hard Skills & Tools

Regulatory Strategy DevelopmentRegulatory Risk AssessmentCMC RequirementsNonclinical RequirementsClinical RequirementsLabeling StrategyPost-Approval StrategyHealth Authority InteractionsRegulatory Due DiligenceThought Leadership Development

Soft Skills

Communication SkillsPresentation SkillsClient Relationship ManagementMentoring Skills