Senior Manager, Regulatory Affairs

About the company

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.

About the team

As part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Manager will oversee and manage the regulatory activities for assigned products/projects and serve as the regulatory representative on cross-functional teams for those projects. Projects may support developmental product activities as well as the life-cycle management of commercial products.

Responsibilities

• Represent Regulatory Affairs on assigned product and related project teams (both internal and external cross-functional teams).
• Provide regulatory assessment of due diligence requests to support new business development activities.
• Serve as primary interface with FDA and Health Canada for assigned products. Prepare and author portions of Health Authority meeting request and briefing documents. Attend Health Authority meetings as assigned.
• Drive regulatory strategies for drug product registration and for life-cycle management across North America.
• Manage regulatory filings including IND, NDA, ANDA, NDS, DMF for a variety of dosage forms including solid oral, parenteral, liquids, topicals, inhalation and nasal, and drug/device combination drug products.
• Respond to FDA or Health Canada Requests for Information.
• Manage operational aspects of preparing compliant submissions to regulatory agencies.
• Establish and manage timelines associated with regulatory submissions.
• Manage archive of regulatory submissions, regulatory correspondence and associated logs and tracking mechanisms as per Azurity SOPs.
• Provide regulatory guidance on requirements for post-approval/life-cycle changes, as required, for assigned commercial products including change control assessments.
• Provide regulatory support for Senior Leadership Team (SLT) and Executive Leadership Team (ELT) meetings and presentations.
• Monitor evolving, region-specific regulations and proactively provide strategic guidance to cross-functional teams to ensure compliance.
• Assist in preparing budgets and reviewing invoices on assigned projects and relevant product/filing fees, as needed.
• Participate in various activities of setting goals, tracking deliverables and process improvements within the regulatory department.

Requirements

• Minimum Bachelor of Science or preferred advanced health care discipline degree (PharmD, PhD, Master of Science, etc.) or equivalent qualification.
• Minimum of 10 years in the pharmaceutical industry with at least 8 of those years in regulatory affairs.
• Combination of education and applicable job experience may be considered.
• Excellent organizational, interpersonal, verbal, and written communication skills, strong grammar, and proofreading/editing skills, and MS Office skills are required.
• Track record of successfully working with cross-functional teams, including external partners.
• Ability to work independently with minimal supervision in a fast-paced deadline driven environment.
• Keen attention to detail.
• Ability to rapidly adapt to changing environment and circumstances that require flexibility, tolerance and a great sense of urgency while ensuring that all regulatory requirements are met.
• Ability to successfully communicate, negotiate and influence regulatory strategy to key stakeholders.

Physical & Mental Requirements

• 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.

Benefits

• Competitive compensation package, including an annual bonus based on company performance.
• Sales roles: Incentive compensation program that allows you to earn more—even over plan.
• Sales roles: Car reimbursement program and gas card for both business and personal use.
• Comprehensive health coverage: medical, dental, vision, and prescription.
• Hybrid work model: two days from home and three days in the office (excludes Sales, Manufacturing, and some Operations positions).
• Retirement Savings Plan (401K) with dollar-for-dollar matching up to 5%.
• Up to 15 vacation days annually + rollover (up to 40 hours), plus five sick/wellness days. Vacation accrual prorated for new employees based on start date.
• Extra week off between Christmas and New Year’s.
• 13 recognized holidays over the course of the year.
• Tuition reimbursement for undergraduate and graduate level courses or certifications.
• Azurity High Five peer recognition platform to celebrate and receive recognition for outstanding work.