Senior Director, Regulatory Clinical Strategy

About Pacira

At Pacira BioSciences, Inc., we are a pioneer in non-opioid pain management and regenerative health solutions. Building on our legacy, we develop next-generation innovations for chronic, postsurgical, and musculoskeletal pain. Our culture is rooted in collaboration, innovation, and a shared commitment to helping patients recover faster. We are redefining what’s possible in pain management and seek talented individuals to join our mission-driven team.

Why Join Us

At Pacira, every career is more than a job—it’s an opportunity to challenge the status quo and achieve the extraordinary. Our mission drives us, and integrity is at the core of who we are. We value diverse perspectives and the collective strength of a unified team, working together to make better possible for patients everywhere.

About the Role

This role directs, manages, evaluates, and implements regulatory projects in support of company goals within clinical strategy. You will play a major role in shaping cohesive regulatory strategy across assigned programs, ensuring effective integration of regulatory ideas and tactics that align with program and platform objectives. Responsibilities may span global, regional, or local scopes based on program status.

Responsibilities

• Lead the development of regulatory strategy for multiple and/or complex projects (from first-in-human to post-marketing application stage), including Global Regulatory Strategy Documents, regulatory submissions, and health authority (HA) communications.
• Analyze and address complex regulatory issues, providing advanced solutions and guidance to cross-functional teams and leadership.
• Advise senior management on the status of global regulatory affairs strategies, practices, and procedures.
• Align with cross-functional teams to develop and manage project plans and timelines, ensuring prioritization and on-time execution of key goals.
• Influence the regulatory environment through active participation in conferences, trade associations, industry/agency meetings, and committees. Stay current on evolving regulations and provide regulatory intelligence, including competitive insights that shape strategy.
• Supervise and mentor direct reports to facilitate professional growth, identify training opportunities, and ensure development aligned with roles and responsibilities.
• Identify resourcing needs and allocate activities to internal and external support as required.
• Drive continuous process improvements to enable an efficient and lean organization.
• Support budgeting and forecasting for the Regulatory Affairs function and department.
• Manage vendors and contractors as applicable.
• Perform other responsibilities as needed.

Qualifications

• Bachelor’s degree in a life science with a minimum of 10 years of progressively responsible experience in Regulatory Affairs in the U.S. pharmaceutical industry; or
• Master’s degree in a life science with a minimum of 8 years of progressively responsible experience in Regulatory Affairs in the U.S. pharmaceutical industry; or
• Doctoral degree (M.D., Ph.D., Pharm.D., etc.) with a minimum of 6 years of progressively responsible experience in Regulatory Affairs in the U.S. pharmaceutical industry.
• Managerial experience is desirable.

Skills

• Demonstrated expertise in creating and assessing proposals for regulatory authorities on regulatory paths and clinical plans, and leading productive health authority interactions, including well-organized preparation of cross-functional teams.
• Business-minded leader capable of strategic thinking and proposing innovative solutions to regulatory challenges.
• Advanced proficiency in analyzing and interpreting data, protocols, safety reporting, labeling, and other drug development activities for assigned products.
• Expertise in evaluating regulatory pathways and strategies, and guiding development teams with recommendations based on ongoing regulatory outcomes.
• Ability to articulate the organization’s strategic vision and core values, and contribute to improving internal regulatory policies, programs, and initiatives.
• Excellent communication skills, with the ability to influence decisions, liaise internally and externally, and present regulatory strategy plans and submission documents effectively.
• Proven ability to provide regulatory leadership in a cross-functional, matrix environment.
• Technical expertise in regulatory affairs science, including advanced knowledge of regulatory frameworks and external environments.
• Expert knowledge of global, regional, and local regulatory legislation, laws, procedures, and guidance for pharmaceutical development, including nonclinical and clinical requirements for drug development, registration, and maintenance.
• Experience working within, and potentially managing, the Medical, Legal, and Regulatory (MLR) review process for promotional materials.
• Experience in the preparation and post-approval management of prescription drug, biological, and/or medical device labeling.
• Experience working with FDA’s Office of Prescription Drug Promotion (OPDP) and submission of promotional materials.
• Advanced knowledge of regulations and guidances related to the commercialization of pharmaceutical, biological, and/or medical device products in the U.S.; global experience is preferred.
• Outstanding written and verbal communication skills in English.
• Strong analytical, critical thinking, negotiation, and problem-solving skills.
• Excellent project management skills with keen attention to detail.
• Expert proficiency in MS Word and adherence to internal templates and standards for regulatory submission documents.
• Results-oriented with an enthusiastic attitude, strong interpersonal skills, and the ability to balance detail with strategic vision.

Benefits

• Medical, prescription, dental, and vision coverage.
• Flexible Spending Account (FSA) and Health Savings Account (HSA) with company match.
• Employee Assistance Program (EAP) and mental health resources.
• Disability coverage, life insurance, critical illness, and accident insurance.
• Legal and identity theft protection, pet insurance, fertility and maternity assistance.
• 401(k) with company match.
• Flexible Time Off (FTO) and 11 paid holidays.
• Paid parental leave.

Pay

The base pay range for this role is $203,000 to $267,000 annually. This range reflects what we reasonably expect to pay and considers factors such as geographic markets, business needs, skill sets, experience, training, licensure, and certifications.