Senior Director, Regulatory Affairs Advertising, Promotion Labeling

Overview

At Pacira, innovation meets purpose.

Pacira Bio Sciences, 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

This role directs, manages, evaluates and implements regulatory projects in support of company goals in the area of advertising, promotion and labeling. The position also provides guidance to cross‑functional teams on regulatory strategy and tactics related to external communications and product labeling.

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.

Advertising and Promotion

• Participate in and provide regulatory leadership and expertise to the Public Communications Review Committee (PCRC), which focuses on review of externally facing communications for commercial and investigational products.
• Develop and execute regulatory strategies and processes related to review and approval of externally facing communications or activities for commercial and investigational products by PCRC.
• Oversee all aspects of PCRC regulatory reviewers as appropriate to ensure successful review and approval of advertising and promotional materials.
• Serve as primary regulatory liaison to commercial, medical affairs, legal, etc. to ensure our practices are compliant with current regulatory standards.
• Develop and maintain current regulatory knowledge in the areas of advertising and promotion and advise management of significant developments. Ensure that the regulatory environment is continually monitored for new regulations, guidance, enforcement priorities and trends.
• Assure alignment and consistency of company policies across therapeutic areas and brands with respect to advertising and promotion review.
• Oversee the development and execution of regulatory strategies and processes as it relates to advertising and promotional materials.
• Plan and manage regulatory submissions related to advertising and promotional materials.

Labeling

• Establish and oversee formal processes to provide regulatory support in the development, revision, review, and approval of labeling content for submission to Health Authorities (USPI, EU PI, and ROW labeling, as well as the internal Company Core Data Sheet).
• Develop and execute regulatory strategies and processes related to product labeling for commercial and investigational products.
• Lead organization in the strategic development of core data sheets and eventual product labeling.
• Coordinate with Clinical Regulatory to plan and manage regulatory submissions related to labeling and label changes.
• Develop and implement business processes to support product labeling activities.
• Participate on project and program teams and provide expertise on regulatory matters related to product labeling.
• Represent the company in its dealings with the FDA's OPDP and well as FDA Review Divisions pertaining to labeling.

• Lead or contribute to various cross‑functional and cross‑department continuous improvement initiatives

Leadership

• Supervise and mentor direct reports to facilitate professional growth; identify training opportunities and provide mentoring to ensure individuals are appropriately developed in accordance with their roles and responsibilities.
• Identify resourcing needs and appropriate allocation activities to internal and external support.
• Drive continuous process improvements to enable an efficient and lean organization.
• Support budgeting…