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AbbVie Associate Director - Statistics, Specialty TA (Hybrid)
AbbVie
Pharmaceuticals
Biotechnology
Healthcare
Hybrid$142k - $269k
Full-time
Mid-level
Director
H1B Visa Sponsor
UK Visa Sponsor
Provide statistical leadership for design, analysis, reporting and regulatory submission strategy for clinical development and life-cycle management of assigned projects. Mentor and supervise statisticians, collaborate with cross-functional teams, and ensure regulatory compliance and high-quality statistical deliverables.
$142k - $269k
statistical methodology
statistical analysis plans
data presentation
+1 more
Director, U.S. Medical Affairs, Liver Strategy
Gilead Sciences, Inc.
Biotechnology
Pharmaceuticals
Healthcare
Foster City, California – Remote$243k - $315k
Full-time
Mid-level
AI Engineer
H1B Visa Sponsor
UK Visa Sponsor
Serve as a strategic and operational leader for US Medical Affairs Liver, developing and operationalizing medical materials, governance, and field-ready resources. Partner cross-functionally to ensure compliant, high-impact scientific communications and drive digital innovation and lifecycle management.
$243k - $315k
digital platforms (e.g., CLM/MedDocs)
AI-enabled solutions
Senior Director, Safety Physician
Amylyx Pharmaceuticals
Pharmaceuticals
Biotechnology
Remote$276k - $310k
Full-time
Senior
Clinical Operations
H1B Visa Sponsor
The Senior Director, Safety Physician will serve as a medical safety expert for assigned programs, providing oversight of safety data from clinical development through post-marketing surveillance. They will lead safety assessments, signal detection, regulatory interactions, and partner cross-functionally to inform risk management and safety strategy.
$276k - $310k
Senior Manager, Regulatory Affairs, CMC
Shionogi Inc.
Pharmaceuticals
Biotechnology
Healthcare
Florham Park, New Jersey – Hybrid$140k - $170k
Full-time
Senior
AI Engineer
H1B Visa Sponsor
UK Visa Sponsor
Provide strategic CMC regulatory support and manage preparation and submission of regulatory CMC documents for filings such as INDs, NDAs, and MAAs. Serve as a key regulatory contact, align cross-functional teams, monitor global regulatory requirements, and mitigate risks to support product development timelines.
$140k - $170k
Senior Manager, Regulatory Affairs, CMC
Shionogi Inc.
Pharmaceuticals
Biotechnology
Healthcare
Florham Park, New Jersey – Hybrid$140k - $170k
Full-time
Senior
AI Engineer
H1B Visa Sponsor
UK Visa Sponsor
The Senior Manager, Regulatory Affairs CMC develops and implements regulatory strategies for CMC aspects of product development and oversees preparation and submission of CMC regulatory documents. This role serves as a key contact with regulatory agencies, manages regulatory risks, and supports cross-functional alignment to drive regulatory milestones.
$140k - $170k
Director, US Regulatory Affairs Lead
Shionogi Inc.
Pharmaceuticals
Biotechnology
Healthcare
Florham Park, New Jersey – Hybrid$210k - $250k
Full-time
Leadership
AI Engineer
H1B Visa Sponsor
UK Visa Sponsor
Serve as the Regulatory Affairs lead for assigned products, providing strategic regulatory guidance, managing regulatory submissions and health-authority interactions. Integrate regulatory requirements with business objectives to support product development, approvals, and lifecycle management.
$210k - $250k
Senior Oncology Account Manager (OAM) – South Region-Remote- Tampa, Florida
IDEAYA Biosciences, Inc.
Biotechnology
Pharmaceuticals
Drug Development
Tampa, Florida – Hybrid$187k - $231k
Full-time
Senior
Account Manager
H1B Visa Sponsor
UK Visa Sponsor
The Senior Oncology Account Manager will lead territory strategy and drive launch and adoption of darovasertib within the Florida territory. This field-based role requires deep scientific credibility, cross-functional collaboration, and extensive travel to engage academic and community oncology stakeholders.
$187k - $231k
Release Manager (H/F)
SeqOne
biotechnology
Remote
€44k - €60k
Full-time
Mid-level
Director
You will manage release plans, schedules and hotfix execution while aligning Engineering, QA, Regulatory and Product teams. You will also improve release predictability by implementing processes, tracking metrics and ensuring compliance with IVDR/ISO13485.
€44k - €60k
Git
JIRA
Notion
+4 more
Release Manager (H/F)
SeqOne
biotechnology
Remote
€44k - €60k
Full-time
Mid-level
Director
Lead and execute release plans and emergency hotfix processes for SeqOne's regulated genomics SaaS, ensuring traceability and regulatory compliance. Coordinate across Engineering, Bioinformatics, AI, QA, Regulatory Affairs and Product while improving release processes and metrics.
€44k - €60k
Git
JIRA
Notion
+4 more
Director, Regulatory Writing - Greenhouse
Entrada Therapeutics
Biotechnology
Pharmaceuticals
Boston, Massachusetts – Hybrid$220k - $250k
Full-time
Mid-level
Director
H1B Visa Sponsor
The Director of Regulatory Writing will manage authoring of regulatory submission components, serve as a lead author and document specialist, and liaise with external writing providers. This role supports submission planning, process development, and cross-functional collaboration to advance Entrada’s pipeline.
$220k - $250k
Microsoft Word
eCTD
Release Manager (H/F)
SeqOne
biotechnology
Paris – Hybrid€44k - €60k
Full-time
Mid-level
Director
You will own release planning and execution for SeqOne’s regulated SaaS products, coordinating engineering, bioinformatics, QA, regulatory and product teams. You will improve release process maturity, manage hotfixes, and ensure traceability to meet IVDR/ISO requirements.
€44k - €60k
Git
JIRA
Notion
+4 more
Director, Pharmacovigilance Operations
TerSera Therapeutics LLC
Pharmaceuticals
Biotechnology
Deerfield, Illinois – Hybrid$210k - $250k
Full-time
Mid-level
Clinical Operations
H1B Visa Sponsor
The Director, Pharmacovigilance Operations provides day-to-day oversight of TerSera's PV system and ensures delegated PV activities comply with regulatory requirements and company procedures. This role leads vendor oversight, inspection readiness, quality oversight, training governance, and cross-functional PV governance activities.
$210k - $250k
Senior Director, Quality Compliance and Risk Management
Braveheart Bio, Inc.
Biotechnology
Pharmaceuticals
Life Sciences
San Francisco, California – Hybrid$225k - $290k
Full-time
Senior
Compliance
H1B Visa Sponsor
Provide senior-level leadership for quality compliance, risk management, vendor qualification/oversight, audits and inspection readiness across GxP activities. Collaborate cross-functionally and with external vendors to identify, evaluate, and mitigate complex quality risks as the company advances through late-stage development and commercialization.
$225k - $290k
GxP
GMP
GCP
+4 more
Regional Manager - Great Lakes
Azurity Pharmaceuticals
Pharmaceuticals
Biotechnology
Healthcare
HybridFull-time
Mid-level
Sales
H1B Visa Sponsor
Manage, develop, and coach a district of sales representatives to exceed territory performance while partnering with cross-functional teams to optimize sales force alignment and commercial strategy. Execute CRM-driven engagement, territory planning, incentive compensation, and training to support product launches and ongoing growth.
CRM systems
Azurity Commercial Excellence (ACE) platform
Microsoft Word
+8 more
Senior Director, Quality Compliance and Risk Management
Braveheart Bio, Inc.
Biotechnology
Pharmaceuticals
Life Sciences
San Francisco, California – Hybrid$225k - $290k
Full-time
Senior
Compliance
H1B Visa Sponsor
Provide senior-level leadership for quality compliance, Quality Risk Management, vendor qualification and oversight, audit programs, inspection readiness, and data integrity. Collaborate cross-functionally and manage regulatory inspections while identifying and mitigating complex GxP quality risks.
$225k - $290k
computerized system validation
GxP systems
data integrity
Associate Director/Senior Manager, Health Economics & Outcomes Research - Organ Health
Natera, Inc.
Biotechnology
Medical Diagnostics
Healthcare
Remote$157k - $218k
Full-time
Senior
Director
H1B Visa Sponsor
UK Visa Sponsor
Lead HEOR strategy and evidence generation to demonstrate the clinical and economic value of Natera’s precision molecular diagnostics across organ health. Develop economic models, analyze real-world and clinical data, drive publications, and translate evidence for market access and payer adoption.
$157k - $218k
Microsoft Excel
TreeAge Pro
R
+6 more
Director - Regulatory Affairs Resource, Analytics and Insights Lead
Gilead Sciences, Inc.
Biotechnology
Pharmaceuticals
Healthcare
Parsippany, New Jersey – Remote$191k - $248k
Full-time
Leadership
Director
H1B Visa Sponsor
UK Visa Sponsor
Lead resource management and analytics for Regulatory Affairs, owning data quality, forecasting tools (Planisware, Smartsheet) and workforce planning. Partner with RA leadership, Finance and HR to provide actionable recommendations and drive cross-functional improvements to ensure capacity and compliance.
$191k - $248k
Planisware
Smartsheet
Smartsheet Resource Manager
+3 more
Director, Regulatory Affairs
Viking Therapeutics, Inc.
Biotechnology
Pharmaceuticals
San Diego, California – Office$190k - $210k
Full-time
Mid-level
AI Engineer
H1B Visa Sponsor
Manage and execute global regulatory submissions (including NDA filing), maintain regulatory records, and perform detailed quality control of submission documents. Serve as a regulatory contributor in cross-functional teams, supervise external vendors, and support inspection readiness and health authority interactions.
$190k - $210k
Microsoft Word
Microsoft PowerPoint
Microsoft Outlook
+6 more
Senior Director, Government Programs
Phlow Corporation
Pharmaceuticals
Biotechnology
Richmond, Virginia – Hybrid$170k - $210k
Full-time
Senior
Director
H1B Visa Sponsor
Serve as Phlow's principal leader for government contracts and programs, overseeing compliance, milestones, and relationships with agencies such as BARDA and DoD. Partner cross-functionally to support proposal development, audit readiness, and program execution while managing risks and agency engagement.
$170k - $210k
Senior Director, Alliance Management
Halozyme Therapeutics, Inc.
Biotechnology
Pharmaceuticals
Boston, Massachusetts – Office$214k - $290k
Full-time
Senior
Director
H1B Visa Sponsor
The Senior Director, Alliance Management is responsible for executive-level partner relationships, alliance governance, portfolio growth, and ensuring successful execution of partnership objectives. This role leads cross-functional collaboration across product development, quality, regulatory, manufacturing, finance and supply chain to drive program advancement and revenue recognition.
$214k - $290k