Senior Director, Regulatory Affairs Advertising & Promotion

Description

About Pacira

Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients.

Each of our 3 marketed products, both in pharmaceutical and medical device, represent cutting edge technologies for pain management.

We have 700+ employees and have averaged double digit growth year over year for the past 5 years, with $500M in revenue.

We are small enough for you to make your mark, and big enough for you to learn and grow! We have facilities in New Jersey, California and Florida.

Our San Diego, CA campus is a world class manufacturing and R&D facility. We are rapidly growing and have opportunities across all of our sites and functional areas.

Why work with us?

Rarely do you have an opportunity to do work that really matters. What drives us is our mission. What makes us successful are our people.

At Pacira, you are part of an inclusive culture that fosters collaboration, growth, and innovative thinking a place where you can make an impact and help change the standard of care in non-opioid pain management.

Be part of our movement, let’s pursue excellence together. Summary : This role directs, manages, evaluates and implements regulatory projects in support of company goals in the area of labeling and promotion.

The position also provides guidance to cross-functional teams on regulatory strategy and tactics related to external communications and product labeling.

Essential Duties & Responsibilities : Advertising 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.

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

Supervisory Responsibilities : This position has direct supervisor responsibilities. Interaction : Work closely with employees in all functional areas of the company to provide regulatory guidance and support. Education and Experience :

• 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

Knowledge, Skills, and Abilities :

• 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

Physical Demands : While performing the duties of this job, the employee is regularly required to sit, talk, move between spaces, reach with hands and arms and stoop.

Close vision and the need to focus on computer screen, use of hands, fingers, and wrist to type on keyboard and manipulate mouse.

Work Environment : Benefits :

• 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
5 days ago