Director, Clinical Regulatory Affairs - Pipeline Lead

Regulatory AffairsRemote, Parsippany, NJ United States


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. Our in-depth knowledge of non-opioid pain management, coupled with our passion for advancing patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results.

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.


The primary purpose of this position is to develop complex and potentially novel regulatory strategies, identify and implement appropriate global submission strategies for assigned projects or a category of products. The incumbent will be responsible for providing regulatory expertise and lead regulatory projects for the Pacira BioSciences clinical regulatory team.

Essential Duties & Responsibilities:

  • Provides long-term regulatory strategies including executable submission plans to FDA and other international health agencies in the areas of gene therapy and/or new drug development.
  • Manage cross-functional teams in the creation of IND/CTA applications, NDA/MAA/BLA applications, annual reports, investigator brochures, clinical reports and meeting requests/briefing packages.
  • Acts as the Regulatory Affairs representative leading regulatory interactions with and presenting to Regulatory Health Authorities, customers and partners, whilst providing current regulatory information and guidance to project teams on a proactive basis.
  • Develops and/or oversees multiple regulatory strategies, identifying and implementing appropriate submission strategies for assigned projects; whilst additionally providing input for product labeling, non clinical and clinical development. Responsible for establishing strategies for document generation, contributing strategically and scientifically at the project and/or study team level.
  • Manages external global vendors regarding all potential areas of regulatory support, document quality, working seamlessly with internal Publishers.
  • Ensures regulatory submissions are of high quality and submitted in a timely manner, reviews regulatory filings for accuracy, completeness and compliance with applicable regulatory requirements and internal procedures. 
  • Independently develops regulatory documents for regulatory submission such as eCTD module 2 summaries, health authority meeting briefing documents, and other regulatory documents as needed.
  • Ensures key messages are clear and consistent within and across documents.
  • Contributes strategically and scientifically at the project team level.
  • Contributes to formation of key messages in consultation with functional area experts.
  • Advises project and study teams regarding regulatory requirements and guidance.
  • Reviews and approves Study Protocols, Clinical Study Reports, Statistical Analysis Plans, ISS, ISE and product labeling.
  • Ensures fulfillment of commitments made to various health agencies (e.g., IND/NDA/MAA/BLA pediatric and post-marketing commitments).
  • Contributes interdepartmentally to Clinical/Medical, Drug Safety, and R&D departments as needed.

Supervisory Responsibilities:
This position may be responsible for people development and have direct reports whilst additionally assisting with the oversight of a variety of vendors.


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. / globally within the pharmaceutical industry required


To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Regulatory experience within Gene Therapy and NCEs development including prior experience working on IND, NDA and BLA in the US, and ex-US equivalents.
  • Knowledge of clinical development required; knowledge of nonclinical, clinical pharmacology, biostatistics desirable.
  • Regulatory experience in Europe and/or other major geographic regions desirable.
  • 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 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.

Work Environment:

The work setting is consistent of a typical pharmaceutical office environment with offices and cubicles. Flexible or work from home opportunities possible.


  • 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 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.  

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.