Senior Director, Regulatory Affairs Advertising, Promotion, & Labeling

Pacira Pharmaceuticals, Inc.•Parsippany-Troy Hills, NJ

17d

About The Position

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 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.

Requirements

Bachelor 's degree in a life science with a minimum of 10 years 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 progressively responsible experience in Regulatory Affairs in the U.S. pharmaceutical industry; or
Doctoral (M.D., Ph.D., Pharm.D., etc.) degree with a minimum 6-year progressively responsible experience in Regulatory Affairs in the U.S. pharmaceutical industry
Managerial experience desirable
Excellent written and oral English communication skills
Experience working within, and potentially managing, the Medical, Legal and Regulatory review process of promotional materials
Experience and knowledge in the preparation of and post-approval management of prescription drug, biological, and/or medical device labeling
Experience working with FDA's 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 US; experience in other global regions is preferred
Outstanding written and verbal communication skills
Excellent analytical and critical thinking skills
Demonstrated negotiation and problem-solving skills
Strong project management skills with keen attention to detail
Expert knowledge of MS Word and ability to ensure adherence to internal templates and standards for regulatory submission documents
Results-oriented with an enthusiastic attitude and strong interpersonal skills
Proven attention to detail, while at the same time seeing the big strategic picture

Responsibilities

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.
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
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 and forecasting for function and Regulatory Affairs department.
Manage vendors and contractors as applicable.
Other responsibilities as needed.