Executive Director, Regulatory Clinical Strategy

At Pacira, innovation meets purpose.

Pacira BioSciences, Inc. is a pioneer in non-opioid pain management and regenerative health solutions. Today, we're building on that legacy with next-generation innovations for chronic, postsurgical, and musculoskeletal pain. Our culture is built on collaboration, innovation, and a shared commitment to helping patients recover faster. We are redefining what's possible in pain management-and we can't do it without talented people like you.

Why Join Us?

At Pacira, every career is more than a job. Our mission drives us, and every day, we challenge ourselves to achieve the extraordinary. Integrity is at the core of who we are. We value diverse perspectives and the collective strength of a unified team. Join the team in making better possible for patients everywhere.

Summary

The Executive Director, Regulatory Affairs Clinical Strategy provides strategic leadership, direction, and oversight for regulatory projects in support of company goals within the area of clinical strategy. This role is accountable for shaping and driving cohesive regulatory strategy across assigned programs and ensuring the effective integration of broad regulatory approaches and tactics that support overall program and platform objectives. As a senior regulatory leader, the Executive Director partners closely with executive leadership and cross-functional stakeholders to influence key development decisions, assess regulatory risks and opportunities, and ensure alignment of regulatory strategy with business priorities. Responsibilities may span global, regional, or local initiatives depending on program status and organizational needs.

Essential Duties & Responsibilities:

The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned.

Regulatory Affairs Clinical-Nonclinical Strategy

• Provide strategic leadership and oversight for the development of regulatory strategy for multiple and/or complex projects (from first-in-human to post-marketing application stage) as outlined in Global Regulatory Strategy Documents, including regulatory submission documents and Health Authority (HA) communications.
• Lead the evaluation and resolution of complex regulatory issues, providing expert regulatory guidance and strategic direction to cross-functional teams and Regulatory Affairs leadership. Serve as a trusted advisor to senior and executive management on global regulatory strategies, tactics, policies, practices, and procedures.
• Drive alignment across cross-functional teams to oversee the development and execution of project plans and timelines, ensuring regulatory priorities are appropriately balanced, critical milestones are achieved, and strategic objectives are met.
• Shape and influence the external regulatory environment through active participation in relevant conferences, trade associations, industry and health authority meetings, and professional committees. Monitor evolving regulatory trends and provide strategic regulatory intelligence, policy guidance, and competitive insights that inform business and development strategies.

Executive Leadership

• Lead, develop, and mentor regulatory professionals and/or matrixed contributors, including setting expectations, providing coaching, supporting professional growth, and strengthening functional capability.
• Identify resourcing needs and guide allocation of internal resources, external consultants, vendors, and contractors to support portfolio and functional priorities.
• Drive continuous improvement of regulatory processes, operating models, templates, and ways of working to enable an efficient, scalable, and compliant organization.
• Support functional budgeting, forecasting, resource planning, and vendor oversight for the Regulatory Affairs department, as applicable.
• Build strong relationships with senior leaders and cross-functional stakeholders to influence strategy, align priorities, and support timely decision-making in a matrix environment.
• Model strong leadership judgment, accountability, collaboration, and the organization's core values while helping establish a high-performing regulatory culture.

Supervisory Responsibilities:

This position may have direct supervisory responsibilities and may lead managers, senior-level professionals, consultants, vendors, and/or matrixed cross-functional contributors, as applicable.

Education and Experience:

• Bachelor's degree in a life science or related field required; advanced degree such as M.S., Ph.D., Pharm.D., M.D., or equivalent preferred.
• Minimum of 14 years of progressively responsible experience in Regulatory Affairs within the U.S. pharmaceutical, biotechnology, biological, and/or medical device industry, including significant experience leading clinical regulatory strategy for complex programs.
• Demonstrated experience leading health authority interactions, regulatory submissions, global/regional/local strategy development, and cross-functional regulatory decision-making.
• Prior people leadership, matrix leadership, vendor management, and/or functional resource planning experience required.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Knowledge, Skills, and Abilities:

• Expert knowledge of regulatory affairs strategy, regulatory science, pharmaceutical development, and global/regional/local regulatory legislation, laws, procedures, guidance, and external regulatory environments.
• Demonstrated executive-level ability to create, assess, and defend proposals to regulatory authorities on regulatory pathways, clinical plans, and development strategies.
• Advanced ability to analyze and interpret data, protocols, safety reporting, labeling, and other activities related to drug development and lifecycle management.
• Proven ability to assess the adequacy of proposed regulatory pathways and guide development teams toward refinements based on regulatory outcomes and evolving program needs.
• Strong business acumen with the ability to connect regulatory strategy to broader program, portfolio, and organizational goals.
• Excellent executive communication skills, including the ability to influence decisions, communicate with all levels of the company, and present regulatory strategy, submissions, and recommendations clearly in writing and verbally.
• Demonstrated ability to lead cross-functional teams and work effectively in a matrix environment with competing priorities and complex stakeholder needs.
• Experience working within, and potentially managing, Medical, Legal, and Regulatory review processes for promotional materials preferred.
• Experience and knowledge in the preparation of and post-approval management of prescription drug, biological, and/or medical device labeling preferred.
• Experience working with FDA OPDP and submission of promotional materials preferred.
• Advanced knowledge of regulations and guidance related to commercialization of pharmaceutical, biological, and/or medical device products in the U.S.; experience in other global regions preferred.
• Outstanding written and verbal communication skills, analytical and critical thinking skills, negotiation skills, problem-solving skills, and project management discipline.
• Strong attention to detail with the ability to maintain focus on the broader strategic picture and organizational impact.
• Expert proficiency with Microsoft Word and ability to ensure adherence to internal templates and standards for regulatory submission documents.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Regularly required to sit, use hands and fingers, operate a computer, and communicate verbally and in writing.
• May be required to stand, walk, reach, and occasionally lift or move standard office materials.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Work is generally performed in a professional office, hybrid, or remote business environment, as applicable to business needs.
• Travel may be required to support health authority meetings, industry forums, business meetings, or other company needs.

• Medical, Prescription, Dental, Vision Coverage
• Flexible Spending Account & Health Savings Account with Company match
• Employee Assistance Program
• 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

The base pay range for this role is $229,000 annually to $300,000 annually.

The range is what we reasonably expect to pay for this role. The range considers a wide range of factors that are considered in making compensation decisions, including but not limited to: geographic markets, business or organizational needs, skill sets, experience, training, licensure, and certifications. Depending on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered.

EEO Statement: Pacira is proud to be an Equal Opportunity Employer and does not discriminate against applicants because of race, color, religion, sex (including gender identity, sexual orientation, and pregnancy), national origin, age (40 or older), veteran status, disability or genetic information, or any other characteristic protected under applicable federal, state, or local law. At Pacira we are committed to intentionally cultivating a culture of inclusion where all feel welcomed and valued for their background, perspectives, and experiences. We hold one another accountable to promote trust and transparency in support of our communities and collective purpose.
Agency Disclaimer: Pacira Biosciences, Inc. (Hereafter, Pacira) does not accept unsolicited resumes from recruiters or employment agencies in response to the Pacira Careers page or a Pacira social media post. Pacira will not consider or agree to payment of any referral compensation or recruiter fee relating to unsolicited resumes. Pacira explicitly reserves the right to hire said candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Pacira.