Director, Regulatory Affairs Clinical-Nonclinical Strategy

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 role will be responsible for developing and implementing a worldwide regulatory strategy that leads to the successful registration and life-cycle management of assigned projects. The incumbent will provide regulatory oversight and leadership for assigned products to optimize label and shortest time to approval by regulatory agencies

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.

• Develop worldwide product regulatory strategy to optimize label and obtain the shortest time to approval by regulatory agencies for multiple projects simultaneously.
• Provide expert advice to cross-functional product development teams on regulatory issues as they arise with the pipeline products or marketed products throughout the entire life cycle of the drug.
• Provide leadership and guidance to direct reports in supporting and leading the cross-functional teams for pipeline programs and marketed products.
• Represent Pacira in direct communication with the FDA, including telephone calls and email; chairs meetings between Pacira and the FDA; prepares Pacira teams for meetings with the FDA at any phase of drug development.
• Coordinate interactions with foreign agencies through external regulatory representatives to support their interactions and provide strategic direction across multiple regions simultaneously.
• Provide leadership in preparation of regulatory filings for submission to US and international regulatory agencies in the areas of new drug development, marketing applications, and approved product support. This would include IND applications, meeting requests, post-marketing commitments, and annual reports.
• If applicable, may develop submission plans and provide project management preparation of submission dossiers to US and international health agencies in the areas of medical device development and approved product support. This includes investigational device exemption (IDE), premarket approval (PMA), and premarket notification (510(k)) applications in the US, as well as their ex-US equivalents.
• Review and approve worldwide marketing applications, clinical study reports, and investigator brochures before release from Pacira to external agencies and investigators.
• Conduct initial IND and Clinical Trial Applications (CTA) content review and approval to facilitate initial approval by agencies for conduct of clinical trials.
• Collaborate with regulatory publishing team to ensure regulatory submissions are of high quality and submitted promptly; reviews submissions for accuracy, completeness, and compliance with applicable regulatory requirements and procedures.
• Manage regulatory projects, including overall strategy, resources, costs, time, and vendors, if appropriate, and ensure that project work proceeds according to agreed deadlines and maintains status records.
• Proactively identify and address complex problems; propose solutions, assist in developing solutions, and escalate any unresolved concerns to the senior leadership.
• Participate in regulatory due diligence activities for licensing/partnership candidate review.
• Lead cross-functional efforts to prepare for advisory committee meetings and may speak at the advisory committee.
• Provide a sense of urgency to cross-functional teams responsible for global programs.
• Ensure effective communication and constructive working relationships with business partners and representatives of FDA and other international health authorities.
• Coordinate the preparation, submission, and follow-up contact with regulatory agencies and/or external partner for all applications and submissions
• Assume responsibility for regulatory review for all submissions and associated documentation.

Supervisory Responsibilities

This role may have supervisory responsibilities.

Education and Experience

• Bachelor 's degree in a life science with a minimum of 10 years progressively responsible experience in Regulatory Affairs in the U.S. pharmaceutical industry; or
• Master's degree in a life science with a minimum of 8 years progressively responsible experience in Regulatory Affairs in the U.S. pharmaceutical industry; or
• Doctoral (M.D., Ph.D., Pharm.D., etc.) degree with a minimum 6 years progressively responsible experience in Regulatory Affairs in the U.S. pharmaceutical industry
• Managerial experience desirable

Knowledge, Skills, and Abilities

• Knowledge of clinical development required; knowledge of nonclinical, clinical pharmacology, biostatistics and CMC regulatory desirable
• Regulatory experience with both Biologics and NCEs, including prior experience working on IND, NDA or BLA submissions in the US, and/or ex-US equivalents
• Regulatory experience with medical devices desirable, including prior experience working on IDE, PMA, and 510(k) submissions in the US, and/or ex-US equivalents
• Regulatory experience in Europe and/or other major geographic regions is highly desirable
• Demonstrated knowledge of regulatory requirements with the ability to interpret and apply regulations to specific projects (IND, NDA, GCP, ICH, and other regulatory guidance requirements)
• Ability to manage multiple responsibilities with a high degree of independence
• Strong organizational skills, negotiating, and problem-solving skills
• Excellent written and oral English communication skills
• Proven ability to interact successfully with all levels of the organization
• Demonstrated public speaking skills
• Proven time/project management skills
• Proficiency in Microsoft Office, including Word, Excel, and PowerPoint
• This position requires approximately 5-10% travel with occasional overnight stays

Physical Demands

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 the computer screen, as well as the use of hands, fingers, and wrists to type on the keyboard and manipulate the mouse. Will need to lift and move items weighing up to 40 pounds.

Work Environment:

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 $171,000 annually to $230,000 annually.

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.