Sr. Director, Regulatory Operations

Pacira Pharmaceuticals, Inc.

About The Position

At Pacira, innovation meets purpose. Pacira BioSciences, Inc. is a pioneer in non-opioid pain management and regenerative health solutions. Today, we’re building on that legacy with next-generation innovations for chronic, postsurgical, and musculoskeletal pain. Our culture is built on collaboration, innovation, and a shared commitment to helping patients recover faster. We are redefining what’s possible in pain management—and we can’t do it without talented people like you. Why Join Us? At Pacira, every career is more than a job. Our mission drives us, and every day, we challenge ourselves to achieve the extraordinary. Integrity is at the core of who we are. We value diverse perspectives and the collective strength of a unified team. Join the team in making better possible for patients everywhere. The Senior Director, Regulatory Operations will be responsible for strategic leadership and oversight of the Regulatory Operations infrastructure, including Regulatory Affairs systems, submission and document management, technologies, and the overall Regulatory Information Management System needs for Pacira Pharmaceuticals. Submission management includes submissions planning, publishing, QC, document archiving, and submission to various Health Authorities.

Requirements

Bachelor’s Degree with a major in an analytical field of study from an accredited college or university is required; advanced degree is preferred.
Minimum 12 years of relevant experience in Regulatory Affairs with pharmaceutical or biological products required
Demonstrated ability to lead a small team of Regulatory Operations professionals
Excellent written and oral English communication skills
Proven attention to detail, while at the same time seeing the big strategic picture
Demonstrated strong organizational skills with ability to set priorities and meet deadlines, as well as to respond to changing deadlines and priorities
Demonstrated negotiation and problem-solving skills
Ability to work well independently with minimal supervision
Sound working knowledge of writing and publishing computer applications
Proven ability to communicate well with colleagues across multiple disciplines in the organization

Responsibilities

Provide strong leadership with Information Technology and Regulatory business process expertise to drive the ongoing transformation and continuous improvement within Regulatory Affairs.
Lead the development of Regulatory Information tools and systems, and ensure they are implemented, validated, and maintained in accordance with company SOPs and applicable regulations.
Accountable for all submissions to be error-free from a regulatory validation standpoint and are submitted on time to meet any internal or external requirements.
Accountable and responsible for implementing SOPs and work processes for publishing, submissions, and archiving.
Oversee and manage tracking and timely archiving of regulatory submissions and communications.
Partner with Regulatory Leads as a thought leader in Regulatory Information Management Systems.
Identify and assess risks that can impact submissions e.g., regulatory requirements, capabilities of internal tools, internal projects, etc. and define strategies to mitigate those.
Drive continuous process improvement through leadership of initiatives to capture learnings, identify opportunities for change and in partnership with global peers, develop a change management plan for implementation.
Partner with peers to increase visibility of upcoming submissions and deliverables across the regions.
Lead in the definition of requirements and evaluation of technologies and support system implementation as appropriate.
Direct the development and implementation of standards for dossier management, publishing, archiving, metrics, and submission process for global health authorities.
Oversee management of vendors and contractors as applicable to systems and technology project(s).
Identify training opportunities and provide mentoring to ensure individuals are appropriately developed in accordance with their roles and responsibilities.
Supervise and mentor direct reports to help facilitate professional growth.
Identify resourcing needs and appropriate allocation activities to internal and external support.
Drive continuous process improvements to enable an efficient and lean organization.
Maintain expert knowledge of electronic submission and computerized system validation standards and partner with Regulatory Leads as a thought leader in Regulatory Information Management Systems.
Lead the Regulatory Operations function, with ultimate responsibility for timely, complete, and compliant submissions to regulatory health authorities
Coordinate, manage, and oversee all electronic publishing and submission activities for Regulatory Affairs
Establish and maintain document templates to support Regulatory Affairs
Contribute to defining and implementing standard regulatory processes and practices for Pacira.
Monitor the development of emerging regulations and guidance related to data and electronic submission standards and advise on any impact to Pacira programs or operations
Support budgeting and forecasting for function and Regulatory Affairs department.
Manage vendors and contractors as applicable to systems and technology project(s).
Other responsibilities as needed.