About Pacira

• Prepare and publish regulatory submissions, including but not limited to Investigational New Drug (IND) applications, New Drug Applications (NDA), Marketing Authorization Applications (MAA), and variations.
• Collaborate with cross-functional teams to compile, format, and publish regulatory submissions in compliance with applicable regulations and guidelines.
• Format and compile regulatory documents according to regulatory agency requirements and internal standards.
• Review and approve regulatory documents to ensure accuracy, completeness, and consistency.
• Liaise with functional source areas to ensure documents are compliant and submission ready. Work with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications.
• Ensure the accuracy, completeness, and consistency of regulatory submissions.
• Maintain knowledge of current regulatory guidelines and requirements to ensure compliance.
• Manage electronic document management systems and publishing tools to facilitate efficient submission processes.
• Coordinate with external vendors, such as contract research organizations (CROs) or regulatory consultants, as needed.
• Assist in the development and implementation of work processes related to regulatory publishing activities.
• Support regulatory inspections and audits by providing requested documentation and information.
• Stay updated on industry trends and best practices related to regulatory publishing.

• Minimum 5 years of relevant experience in Regulatory Affairs with pharmaceutical or biological products required
• Bachelor's Degree with a major in an analytical field of study desirable

• Prior experience in regulatory affairs or publishing within the pharmaceutical, biotechnology, or medical device industry
• Familiarity with regulatory guidelines and requirements, such as FDA, EMA, or other relevant authorities
• Proficiency in electronic document management systems and publishing tools; Veeva is preferred
• Strong attention to detail and ability to work with complex documents
• Excellent organizational and time management skills
• Effective communication and collaboration abilities
• Knowledge of eCTD (electronic Common Technical Document) structure and submission processes

• 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

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.