Director, Regulatory Affairs Clinical Strategy

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:
The primary purpose of this position is to develop regulatory strategies and identify and implement appropriate submission strategies for assigned projects. The incumbent will be responsible to provide regulatory expertise and lead regulatory projects for the Pacira BioSciences clinical regulatory team and to lead regulatory interactions with global regulatory health authorities. Primary responsibilities will be for Medical Devices and Combination products.

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.

Act as the Regulatory Affairs representative on assigned projects; Lead regulatory interactions with and presentations to Regulatory Health Authorities, customers and partners; provides current regulatory information and guidance to project teams on a proactive basis.

Develop regulatory strategies and identifies and implements appropriate submission strategies for assigned projects; provide input for product labeling, advertisement and promotion, and clinical projects. Establish strategies for document authoring, contributing strategically and scientifically at the project and/or study team level, managing vendors and external writers with regard to document quality, and developing regulatory writing timelines, processes, and working standards.

Develop submission plans and provide project management preparation of submission dossiers to US and international health agencies in the areas of new drug development and approved product support. This includes IND/CTA applications, NDA/MAA applications, annual reports, investigator brochures, clinical reports, and meeting requests/briefing packages, and others.

Develop submission plans and provide project management preparation of submission dossiers to US and international health agencies in the areas of medical device development and approved product support. This includes investigational device exemption (IDE), premarket approval (PMA), and premarket notification (510(k)) applications in the US, as well as their ex-US equivalents.

Ensure regulatory submissions are of high quality and submitted in a timely manner; review regulatory filings for accuracy, completeness, and compliance with applicable regulatory requirements and internal procedures.

Independently develop regulatory documents for regulatory submission such as eCTD module 2 summaries, health authority meeting briefing documents, and other regulatory documents as needed.

Ensure key messages are clear and consistent within and across documents.

Contribute strategically and scientifically at the project team level.

Contribute to formation of key messages in consultation with functional area experts.

Advise project and study teams regarding regulatory requirements and guidance.

Review and approve Study Protocols, Clinical Study Reports, Statistical Analysis Plans, ISS and product labeling.

Ensure fulfillment of commitments made to various health agencies (e.g., IND/NDA/MAA pediatric and post-marketing commitments, and others).

Manage vendors and external writers with regard to document quality; provides guidance to external writers on company standards and style and industry best practices for regulatory writing.

Contribute interdepartmentally to Clinical/Medical, Drug Safety, and R&D departments as needed.

Supervisory Responsibilities:
This position may be responsible for assisting with the oversight of a variety of vendors and external writers.

Interaction:

The incumbent works closely with employees in all functional areas of the company to provide regulatory guidance and support.

Education and Experience:

Bachelor's degree in a physical or life science from an accredited college or university required; Masters or Doctoral (M.D., Ph.D., Pharm.D., etc.) degree desirable

Minimum 8 years progressively responsible experience in Regulatory Affairs in the U.S. pharmaceutical industry

Qualifications:

Knowledge of clinical development required; knowledge of nonclinical, clinical pharmacology, biostatistics and CMC regulatory desirable

Regulatory experience with NCEs, including prior experience working on IND, NDA submissions in the US, and/or ex-US equivalents

Regulatory experience with medical devices, including prior experience working on IDE, PMA, and 510(k) submissions in the US, and/or ex-US equivalents

Regulatory experience in Europe and/or other major geographic regions desirable

Demonstrated strong understanding of the U.S. Regulatory requirements

Proven ability to interpret and apply regulations to specific projects (FDA and ICH or other regulatory agency guidance requirements)

Excellent written and verbal English communication skills

Demonstrated excellent organizational skills

Proven negotiation skills

Proven ability to manage multiple projects, set priorities and meet deadlines

Excellent skill level in MS Office including Word, Excel and Outlook

This position requires approximately 5-10% travel with occasional overnight stays

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. Will need to lift and move items weighing up to 20 pounds.

Work Environment:

The work setting is consistent of a typical pharmaceutical office environment with offices and cubicles.

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

The base pay range for this role in California is $160,000 per year to $220,000 per year.

The range is what we reasonably expect to pay for this role. The range considers a wide range of factors that are considered in making compensation decisions, including but not limited to: geographic markets, business or organizational needs, skill sets, experience, training, licensure, and certifications.