Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.

Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.

Role and Responsibilities

• Ensure the development and implementing the effectiveness of the robust regulatory strategy and plans for
• projects in development and approved, ensuring continued regulatory compliance for the success of the business
• and for the company to meet its goals.
• Providing regulatory guidance, requirements, and strategy for assigned projects to internal
• and external stakeholders, ensuring compliance with regulations, company standards and commitments.  
• Develop robust regulatory strategies for pipeline assets, considering the necessary clinical and regulatory requirements needed for FDA approval.
• Lead the effective execution of the regulatory strategies for the pre-approval and post-approval regulatory activities.
• Oversight of regulatory team activities, including preparation and management of filings (i.e., IND, PIND, Pre-NDA, Pre-ANDA, ODD, CGT, PFC, iPSP, controlled correspondences, etc.).
• Ensure that NDA and ANDA applications are submitted in alignment with the business goals.
• Conduct technical review of documents and provide regulatory expert advice, and approve the CMC, non-clinical, clinical, labeling documents and technical packages authored by team members to ensure completeness, accuracy and regulatory compliance right-fist-time and adequate documents are submitted to FDA.
• Articulates deep science based technical justifications across the submissions to provide clarity upfront in the initial submissions to avoid deficiencies.
• Manage to address the deficiencies received from FDA within pre-defined time, with adequacy and accuracy right-first time to secure the approvals within first review cycle goal date.
• Ensure regulatory gap analysis of all the applications and track through mitigations for implementation of corrective actions or generating additional technical data at various stages of submissions to fulfill Agency’s evolved expectations and guidance requirements.
• Ensure change controls are evaluated as per the guidance and communicated cross functional teams all the necessary conditions and documents to be fulfilled with appropriate reporting category before implementation of the proposed change.
• Ensure fulfillment of all the regulatory commitments submitted part of original applications, deficiency responses, and post approval change supplements.
• Serves as the senior regulatory liaison with partners, internal stakeholders, and reporting manager to develop strategies and manage products and specific governance.
• Provide leadership support and directs communications and process improvements to regulatory colleagues in the team to ensure compliance, competence, and area consistency.
• Research and analyze regulatory information and maintain current regulatory knowledge to keep abreast of regulatory procedures and changes.
• Coach and develop regulatory associates. Support a culture of high performance and trust, assure that the required level of knowledge and skills are available and identify competency gaps. Establish and implement effective training and development plans.
• Ensure and facilitate communication among peers and associates; proactively communicate critical situations in an adequate and timely manner to interdisciplinary teams and to appropriate management level and technical operations department as appropriate.
• Provide regulatory support for Senior Leadership Team (SLT) and Executive Leadership Team (ELT) meetings, presentations and assist in preparing regulatory budget.
• Participate in various activities of setting goals, tracking deliverables and process improvements within the regulatory department.
• Develop collaborative and respectful relationships with internal and external partners, ensuring activities are performed according to regulatory strategies and assisting with regulatory questions.

Qualifications and Education Requirements

• Master of Pharmacy (M. Pharm): Minimum of 15 years of pharmaceutical industry experience; minimum of 10 years of regulatory experience; clinical experience preferred.
• Demonstrates passion for research, brings innovation to challenging projects, and possesses a willingness to learn and work across diverse therapeutic areas and modalities.
• Strong communication skills (both written and verbal) with an ability to express complex information clearly and concisely.
• Strategic thinker who possesses rigorous scientific proficiency and solid business acumen with the ability to look beyond the current state to identify unique opportunities.
• Sound understanding of the drug development continuum with thorough knowledge of regulatory approval processes.
• Ability to work independently and collaboratively with internal teams fostering a culture of efficiency and teamwork.
• Adept at handling multiple projects and tight deadlines in a fast-paced environment
• Strong quantitative analytical skills, including proficiency with Excel, PowerPoint (or equivalent)
• Familiarity with intellectual property and licensing

Physical & Mental Requirements:

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 accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Must be able to sit for long periods of time
• While performing the duties of this job, the employee is frequently required to stand; walk; sit; talk and/or hear
• May occasionally climb stairs and/or ride elevators
• The employee must occasionally lift and/or move up to 25 pounds
• Employee must be able to manipulate keyboard, operate a telephone and hand-held devices
• Other miscellaneous job duties as required