Director, Regulatory Affairs - CMC
Pacira BioSciences, Inc. | |
life insurance, flexible benefit account, parental leave, paid holidays, flex time, 401(k) | |
United States, California, San Diego | |
10578 Science Center Drive (Show on map) | |
Sep 23, 2024 | |
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.
Summary: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. This position is responsible for assigned regulatory projects to ensure regulatory compliance for approved marketing applications (NDA/MAA/NDS etc.) and leading to successful preparation of clinical trial applications (IND/CTA etc.). It also provides regulatory expertise to the Pacira Pharmaceuticals regulatory team.
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.
Supervisory Responsibilities:
This person may have direct supervisory responsibilities.
Interaction:
The incumbent works closely with employees in all functional areas of the company to provide regulatory guidance and support.
Education and Experience:
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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 boxes of paper and binders weighing up to 20 pounds.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Typical office setting, noise level is moderate with consistent printer, telephone ringing and conversation.
Travel Requirements:
The job requires the employee to be able to travel between Pacira sites, to in person Agency meetings (FDA and International Authorities), and to visit contract organizations or cooperation partners. Approximately 25% travel.
Benefits:
The base pay range for this role in California is $160,000 annually to $220,000 annually.
The range iswhat 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: |