SUMMARY:

This role 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. Submission management includes submissions planning, publishing, QC, document archiving, and submission to various Health Authorities.
Responsibilities:
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.

• 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.
• Assume responsibility and accountability 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).

EDUCATION AND EXPERIENCE:

• 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

KNOWLEDGE, SKILLS, AND ABILITIES:

• 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

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.

• 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.
• Assume responsibility and accountability 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)