Regulatory Affairs Associate/Senior Associate at Azurity Pharmaceuticals

<div class="content-intro"><p><span style="font-family: Arial; font-size: 12pt;">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&nbsp;<a href="http://www.azurity.com/">www.azurity.com</a>.</span></p> <p><span style="font-family: Arial; font-size: 12pt;">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.</span></p></div><p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong>Brief team/department description:</strong></span></p> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">As part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Associate/Senior Associate will assist in preparing, review and submission regulatory filings to the FDA and other global health agencies.&nbsp; The person will play crucial role in managing lifecycle of IND, NDA, ANDA, etc. The Regulatory Affairs Associate/Senior Associate will report to the Associate Director, Regulatory Affairs and will work cross-functionally with other Azurity teams including but not limited to Technical Operation, Quality Assurance, Clinical Development, Medical Affairs.</span></p> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong>Principle Responsibilities:</strong></span></p> <ul> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Provide regulatory assistance with due diligence requests to support new business development activities.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Support interaction with FDA and other regulatory agencies for assigned commercial products.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Assist in compiling and authoring regulatory filings (IND, NDA, ANDA, etc.) and post marketing supplements for assigned products.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Manage the timelines associated with regulatory submissions such as post-marketing periodic reports.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Manage archival of regulatory submissions, regulatory correspondence and associated logs and tracking mechanisms.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Provide regulatory guidance on requirements for post-approval changes, as required, for assigned products.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Review and provide regulatory assessments for change control documentation.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Provide regulatory support to regulatory leadership meetings and presentations.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Keep abreast of current regulations and regulatory guidance, assessing impact to assigned products and internal processes.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Participate in various activities of setting goals, tracking deliverables and process improvements within the regulatory department.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Other duties as assigned.</span></li> </ul> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong>Qualifications and Education Requirements</strong></span></p> <ul> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Minimum of Bachelor of Science or preferred advanced health care discipline degree (PharmD, PhD, Master of Science, etc.) or equivalent qualification.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Minimum of 3 years in the pharmaceutical industry with at least 1 of those years in regulatory affairs.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Combination of education and applicable job experience may be considered.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Excellent organizational, interpersonal, verbal, and&nbsp;written communication skills, strong grammar, and&nbsp;proofreading/editing skills, and MS Office skills are required.​</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Ability to work independently with minimal&nbsp;supervision in a fast-paced deadline driven&nbsp;environment​.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Keen attention to detail.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Ability to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and regulatory requirements are met​.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Ability to successfully communicate, negotiate and influence regulatory strategy to key stakeholders.</span></li> </ul> <p><span style="font-size: 8pt; font-family: arial, helvetica, sans-serif;">#LI-Hybrid<br>#LI-Full-time</span></p><div class="content-conclusion"><p><span style="font-family: Arial; font-size: 12pt;"><strong>Physical &amp; Mental Requirements:</strong></span></p> <p><span style="font-family: Arial; font-size: 12pt;">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.</span></p> <ul type="disc"> <li><span style="font-family: Arial; font-size: 12pt;">Must be able to sit for long periods of time</span></li> <li><span style="font-family: Arial; font-size: 12pt;">While performing the duties of this job, the employee is frequently required to stand; walk; sit; talk and/or hear</span></li> <li><span style="font-family: Arial; font-size: 12pt;">May occasionally climb stairs and/or ride elevators</span></li> <li><span style="font-family: Arial; font-size: 12pt;">The employee must occasionally lift and/or move up to 25 pounds</span></li> <li><span style="font-family: Arial; font-size: 12pt;">Employee must be able to manipulate keyboard, operate a telephone and hand-held devices</span></li> <li><span style="font-family: Arial; font-size: 12pt;">Other miscellaneous job duties as required</span></li> </ul> <p><strong><span style="font-size: 12pt;">Benefits We Offer:</span></strong></p> <ul> <li><span style="font-size: 12pt;">Unlock Your Earning Potential: Join our team and be rewarded with a competitive compensation package, including an annual bonus based on company performance, that recognizes your exceptional talent.</span> <ul> <li><span style="font-size: 12pt;">Sales - In lieu of annual bonuses, we offer an Incentive compensation program that allows you to earn more - even over plan.</span></li> <li><span style="font-size: 12pt;">Fuel Your Success: *<em>Sales Only*</em> - We understand the value of your hard work and provide a car reimbursement program and gas card for both business and personal use as part of our commitment to supporting you.&nbsp;</span></li> </ul> </li> <li><span style="font-size: 12pt;">Comprehensive Health Coverage: We value your well-being and offer excellent medical, dental, vision, and prescription coverage to ensure you and your family are always taken care of.</span></li> <li><span style="font-size: 12pt;">Flexibility for Your Lifestyle: Achieve work-life balance with our hybrid work model, allowing you to work two days from home and three days in the office. *<em>Excludes Sales, Manufacturing, and some Operations positions*</em></span></li> <li><span style="font-size: 12pt;">Invest in Your Future: Our Retirement Savings Plan (401K) is designed to help you secure a comfortable retirement by matching dollar for dollar up to 5%.</span></li> <li><span style="font-size: 12pt;">Time Off That Counts: Take advantage of our generous time off policy, which offers up to 15 vacation days annually + rollover (up to 40 hours) as well as five sick/wellness days. For new employees, vacation accrual will be prorated based on your start date.</span></li> <li><span style="font-size: 12pt;">Meaningful Time with Your Loved Ones: We close between Christmas and New Year’s to give you an extra week off to spend quality time with your family and recharge.</span></li> <li><span style="font-size: 12pt;">Enjoy the Holidays: Over the course of the year, Azurity recognizes 13 holidays.</span></li> <li><span style="font-size: 12pt;">Invest in Your Education: We support your professional growth with tuition reimbursement for undergraduate and graduate level courses or certifications.</span></li> <li><span style="font-size: 12pt;">Recognize and Be Recognized: Our Azurity High Five peer recognition platform allows you to celebrate your colleagues' accomplishments and receive recognition for your own outstanding work.</span></li> </ul> <p>&nbsp;</p> <p><span style="font-family: Arial; font-size: 12pt;">The California Consumer Privacy Act regulates privacy rights and consumer protection for residents of California, United States. For details, click <a href="https://azurity.com/privacy-policy/" target="_blank">here.</a></span></p> <p><span style="font-family: Arial; font-size: 12pt;">The <a href="https://gdpr.eu/" target="_blank">General Data Protection Regulation</a> (GDPR) sets guidelines for the collection and processing of personal information from individuals who live in the European Union (EU).</span></p> <p><span style="font-family: Arial; font-size: 12pt;">&nbsp;</span></p></div>