Regulatory Affairs Associate/Senior Associate

About Azurity Pharmaceuticals

Azurity Pharmaceuticals is a privately owned specialty pharmaceutical company focused on creating innovative medicines for patients whose needs are often overlooked. The organization develops accessible, high-quality products through its integrated capabilities and broad partner network, supporting a commercial portfolio and a late-stage pipeline. Its patient-focused offerings span cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan disease areas, and have reached millions of patients.

Azurity promotes an inclusive workplace and is an Equal Opportunity Employer. The company values strong talent, commitment, integrity, and creativity in people who want to improve patient lives through science and quality.

Team Overview

Within the Regulatory Affairs function, the Regulatory Affairs Associate/Senior Associate will help prepare, review, and submit regulatory documents to the FDA and other global health authorities. This role is important for managing the lifecycle of INDs, NDAs, ANDAs, and similar submissions. The position reports to the Associate Director, Regulatory Affairs and partners with teams across Technical Operations, Quality Assurance, Clinical Development, and Medical Affairs.

Key Responsibilities

• Support due diligence activities by providing regulatory input for new business development efforts.
• Coordinate with the FDA and other agencies on matters related to assigned commercial products.
• Draft and assemble regulatory submissions such as IND, NDA, ANDA, and post-marketing supplements.
• Track and manage submission deadlines, including timelines for periodic post-marketing reports.
• Maintain organized archives for filings, correspondence, logs, and tracking records.
• Advise on regulatory expectations for post-approval product changes when needed.
• Evaluate change control documents and share regulatory assessments.
• Support leadership meetings and presentations with regulatory content.
• Stay current on regulations and guidance, and assess how updates affect products and internal processes.
• Contribute to goal setting, deliverable tracking, and departmental process improvements.
• Perform additional duties as needed.

Qualifications

• Bachelor of Science degree is required; an advanced healthcare-related degree such as PharmD, PhD, or Master of Science is preferred, or an equivalent qualification.
• At least 3 years of pharmaceutical industry experience, including a minimum of 1 year in regulatory affairs.
• A mix of education and relevant work experience may be accepted.
• Strong organization, communication, grammar, proofreading, editing, and interpersonal skills are necessary, along with proficiency in Microsoft Office.
• Ability to work independently with little supervision in a fast-moving, deadline-focused setting.
• High level of accuracy and attention to detail.
• Flexibility to adjust quickly to changing priorities and circumstances while maintaining cGMP and regulatory compliance.
• Capability to communicate, negotiate, and help influence regulatory strategy with key stakeholders.

Physical and Mental Requirements

• Ability to remain seated for extended periods.
• Regularly required to stand, walk, sit, talk, and hear.
• May occasionally need to use stairs or elevators.
• Must be able to lift or move up to 25 pounds on occasion.
• Must be able to use a keyboard, telephone, and handheld devices.
• Other job-related duties may be required.

Benefits

• Competitive compensation package with an annual company-performance-based bonus.
• Sales roles receive incentive compensation instead of annual bonuses; this role is not a sales position, but the benefit language was included in the source.
• Sales-only car reimbursement and gas card support are mentioned in the source benefit section.
• Medical, dental, vision, and prescription coverage for employees and eligible family members.
• Hybrid work model is described in the benefits section, but this role is listed as onsite and the hybrid note excludes some roles.
• 401(k) retirement plan with dollar-for-dollar matching up to 5%.
• Up to 15 vacation days per year, with up to 40 hours of rollover, plus five sick/wellness days.
• Vacation accrual is prorated for new hires based on start date.
• Company-wide closure between Christmas and New Year’s for an additional week off.
• 13 recognized holidays each year.
• Tuition reimbursement for undergraduate and graduate courses or certifications.
• Employee recognition through the Azurity High Five peer recognition platform.

Additional Information

The source also references California Consumer Privacy Act (CCPA) privacy rights and consumer protection information for California residents, as well as General Data Protection Regulation (GDPR) guidance for individuals living in the European Union. These notices are included as provided.