Executive Director, Regulatory Clinical Strategy

Pacira Pharmaceuticals, Inc.•UNAVAILABLE, UNAVAILABLE

14h•Hybrid

About The Position

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.

Requirements

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.
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.
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.

Nice To Haves

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.

Responsibilities

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