Hiring: Associate Director, Regulatory Operations Company: Pacira BioSciences, Inc. Location: Parsippany, NJ Job Posted Time: 2026-09-10 11:48:36 Target Skills & Keywords : Change Management, Microsoft Excel, Microsoft PowerPoint, Project Management, Six Sigma, User Experience About the job Experience: •8+ years of experience in Regulatory Operations within pharma/biotech. •Demonstrated experience with global regulatory submission planning, tracking and lifecycle management. •Deep hands-on expertise and strong knowledge in Veeva RIM functionalities and workflows. •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. Required Skills: •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. •Develop and maintain integrated regulatory plans aligned with global development strategies; provide portfolio-level visibility and reporting to leadership on submission progress and risks. •Ensure consistency and compliance with global regulatory requirements and timelines. •Partner with Regulatory Affairs leads to translate regulatory strategies into actionable operational plans within Veeva. •Support Health Authority interaction tracking, commitments, and follow-up activities. •Enable structured tracking of regulatory objectives, submissions, and approvals across regions. •Serve as the SME for Veeva RIM, with deep expertise across modules (e.g., Registrations, Submissions, Submission Content Planning, Regulatory Objectives and Commitment Tracking). •Support workflow optimization, data governance, and lifecycle management within Veeva RIM. Qualifications: •Solid understanding of the clinical development process and regulatory requirements within the pharmaceutical industry, including regulatory submission pathways (e.g., IND, NDA, BLA, MAA) and lifecycle management activities. •Demonstrated experience in submission planning, tracking, and portfolio reporting, with knowledge of regulatory data governance and compliance standards. •Proficient in Microsoft Word, Excel, and PowerPoint, with effective written and verbal communication skills in English. •Operational familiarity with project management principles and tools (e.g., Microsoft Project, Smartsheet). •Demonstrated capacity to develop and deliver training, supporting adoption of systems and processes. •Exposure to process improvement methodologies (e.g., Lean, Six Sigma) is advantageous. •Analytical capabilities with the ability to utilize RIM data to inform insights and decision-making. •Strategic perspective combined with effective operational execution. •Problem-solving mindset with a focus on continuous improvement. •Contributes to improved transparency and reporting of regulatory activities. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!