Senior Director, Regulatory Labeling and Promotion

• Participate in and provides 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 assure our practices are compliant with current regulatory standards.
• Develop and maintain current regulatory knowledge in the areas of advertising and promotion and advises management of significant developments. Ensures 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 the 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
  
  

• Bachelor's Degree with a major in an analytical field of study from an accredited college or university is required; advanced degree is preferred
• Minimum 10 years of relevant experience in Regulatory Affairs of pharmaceutical, biological, and/or medical device products required

• 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

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.