Jobs and Careers

Associate Director, Regulatory Affairs, CMC

San Diego, United Statesfull_timeVerifiedPosted 17 Oct 2024

💰 $170,000/yr($132,000/yr – $170,000/yr)

About the role

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. Summary: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 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.

Prepare regulatory filings for submission to US and international health agencies in the areas of new drug development, marketing applications and approved product support. This would include IND applications, annual reports, Investigator brochures, and meeting requests.
Ensure conformance to commitments made with various health agencies (e.g., IND/ NDA/ MAA/ NDS commitments).
Propose and/or assist in developing regulatory strategies; identify and implement appropriate submission strategies for assigned projects.
Work with submission manager to ensure regulatory submissions are of high quality and submitted in a timely manner; review submissions for accuracy, completeness, and compliance with applicable regulatory requirements and internal procedures.
Participate in Regulatory interaction and presentations to Regulatory Health Authorities, customers and partners.
Monitor and maintain awareness of regulatory environment assessing impact to business, interpret and disseminate information to affected departments.
When needed, act as Regulatory Affairs CMC liaison with partner companies and contract manufacturers.
Other duties as 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:

Bachelor’s degree in life science or related discipline required; advanced degree is preferred
Minimum 8 years of progressively responsible experience in Regulatory Affairs or related CMC function in the U.S. pharmaceutical industry required

Knowledge, Skills, and Abilities: 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.

Demonstrated strong understanding of the U.S., EU, and Canadian 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 organizational skills
Proven negotiation skills.
Proven ability to manage multiple projects, set priorities and meet deadlines