Senior Director, Regulatory Operations

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.

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).

Leadership Opportunities

• 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.
  
  

Supervisory Responsibilities:

This position has supervisory responsibilities.

Interaction:

Work closely with employees in all functional areas of the company to provide regulatory guidance and support.

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

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 accommodation 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.

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.

The work setting is consistent of a typical pharmaceutical office environment with offices and cubicles.

• Medical, Prescription, Dental, Vision Coverage
• Flexible Spending Account & Health Savings Account with Company match
• Employee Assistance Program
• Mental Health Resources
• Disability Coverage
• Life insurance
• Critical Illness and Accident Insurance
• Legal and Identity Theft Protection
• Pet Insurance
• Fertility and Maternity Assistance
• 401(k) with company match
• Flexible Time Off (FTO) and 11 paid holidays
• Paid Parental Leave

The base pay range for this role is $203,000 to $265,000. The range is what 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: Pacira is proud to be an Equal Opportunity Employer and does not discriminate against applicants because of race, color, religion, sex (including gender identity, sexual orientation, and pregnancy), national origin, age (40 or older), veteran status, disability or genetic information, or any other characteristic protected under applicable federal, state, or local law. At Pacira we are committed to intentionally cultivating a culture of inclusion where all feel welcomed and valued for their background, perspectives, and experiences. We hold one another accountable to promote trust and transparency in support of our communities and collective purpose.
Agency Disclaimer: Pacira Biosciences, Inc. (Hereafter, Pacira) does not accept unsolicited resumes from recruiters or employment agencies in response to the Pacira Careers page or a Pacira social media post. Pacira will not consider or agree to payment of any referral compensation or recruiter fee relating to unsolicited resumes. Pacira explicitly reserves the right to hire said candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Pacira.