Senior Director, Regulatory Clinical Strategy
Pacira BioSciences, Inc.
August 15, 2026
Remote friendly (Parsippany, NJ)
United States
Clinical Research and Development
Summary
This role directs, manages, evaluates and implements regulatory projects to support company clinical strategy goals, shaping cohesive regulatory strategy across assigned programs and integrating regulatory tactics supporting program/platform strategy. Responsibilities may be global, regional, or local.
Responsibilities
- Lead regulatory strategy development for multiple/complex projects from first-in-human through post-marketing, including regulatory submissions and health authority (HA) communications.
- Analyze complex issues; provide advanced regulatory solutions/guidance to cross-functional teams and regulatory leadership; advise senior management on global regulatory strategy status, tactics, practices, and procedures.
- Develop and manage project plans and timelines; ensure appropriate prioritization and on-time achievement of key goals.
- Influence the regulatory environment via conferences, trade associations, and industry/agency regulatory meetings/committees; provide regulatory policy/intelligence and competitive insights.
- Supervise and mentor direct reports; identify training opportunities.
- Identify resourcing needs; allocate internal/external support.
- Drive continuous process improvements; support budgeting/forecasting.
- Manage vendors/contractors as applicable.
Qualifications
- BS life science + 10+ years U.S. pharma Regulatory Affairs experience; or MS + 8+ years; or Doctoral degree + 6+ years. Managerial experience desirable.
Skills/Knowledge (required/preferred)
- Expertise in regulatory paths/clinical plans; health authority interactions.
- Advanced ability to analyze/interprete data, protocols, safety reporting, labeling; knowledge across drug development phases.
- Strategic, business-minded leadership; strong communication (written/verbal), cross-functional/matrix leadership.
- Expert knowledge of global/regional/local regulatory frameworks and U.S. human pharma requirements; nonclinical/clinical requirements.
- Experience with Medical/Legal/Regulatory review of promotional materials; labeling (preparation and post-approval management).
- Experience with FDA OPDP and submission of promotional materials.
- Advanced MS Word knowledge; strong project management and analytical/negotiation skills.
Benefits
- Medical, dental, vision; FSA/HSA with company match; EAP; disability; life insurance; 401(k) match; FTO and 11 paid holidays; paid parental leave.
Pay
- Base range: $203,000–$267,000 annually.
This role directs, manages, evaluates and implements regulatory projects to support company clinical strategy goals, shaping cohesive regulatory strategy across assigned programs and integrating regulatory tactics supporting program/platform strategy. Responsibilities may be global, regional, or local.
Responsibilities
- Lead regulatory strategy development for multiple/complex projects from first-in-human through post-marketing, including regulatory submissions and health authority (HA) communications.
- Analyze complex issues; provide advanced regulatory solutions/guidance to cross-functional teams and regulatory leadership; advise senior management on global regulatory strategy status, tactics, practices, and procedures.
- Develop and manage project plans and timelines; ensure appropriate prioritization and on-time achievement of key goals.
- Influence the regulatory environment via conferences, trade associations, and industry/agency regulatory meetings/committees; provide regulatory policy/intelligence and competitive insights.
- Supervise and mentor direct reports; identify training opportunities.
- Identify resourcing needs; allocate internal/external support.
- Drive continuous process improvements; support budgeting/forecasting.
- Manage vendors/contractors as applicable.
Qualifications
- BS life science + 10+ years U.S. pharma Regulatory Affairs experience; or MS + 8+ years; or Doctoral degree + 6+ years. Managerial experience desirable.
Skills/Knowledge (required/preferred)
- Expertise in regulatory paths/clinical plans; health authority interactions.
- Advanced ability to analyze/interprete data, protocols, safety reporting, labeling; knowledge across drug development phases.
- Strategic, business-minded leadership; strong communication (written/verbal), cross-functional/matrix leadership.
- Expert knowledge of global/regional/local regulatory frameworks and U.S. human pharma requirements; nonclinical/clinical requirements.
- Experience with Medical/Legal/Regulatory review of promotional materials; labeling (preparation and post-approval management).
- Experience with FDA OPDP and submission of promotional materials.
- Advanced MS Word knowledge; strong project management and analytical/negotiation skills.
Benefits
- Medical, dental, vision; FSA/HSA with company match; EAP; disability; life insurance; 401(k) match; FTO and 11 paid holidays; paid parental leave.
Pay
- Base range: $203,000–$267,000 annually.