Regulatory Affairs Lead Jobs in North Carolina

INTRODUCTION

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. 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.

Overview

We are seeking a strategic and influential VP, Global Head of Regulatory Affairs to lead global regulatory strategy and execution across a diverse and complex portfolio. This role drives regulatory success from development through post-approval, ensuring timely submissions, approvals, and global compliance.

KEY RESPONSIBILITIES

- Lead global regulatory strategy across multiple complex programs
- Oversee regional regulatory teams and ensure high-quality compliant submissions
- Direct global submissions and approvals while managing risks
- Lead interactions and negotiations with FDA, EMA, and global regulators
- Partner cross-functionally to align regulatory and market access strategies
- Monitor regulatory trends and adapt development strategies
- Ensure global compliance and oversee vendors/CROs
- Build and lead a high-performing global RA organization
- Communicate risks and strategic insights to leadership

QUALIFICATIONS

- MD, PhD, or PharmD preferred with 15+ years in Regulatory Affairs
- Proven success in global regulatory submissions and approvals
- Deep expertise across FDA, EMA, and international regulatory frameworks
- Strong NCE and clinical development experience
- Experience with 505(b)(2) and/or EU Hybrid pathways preferred
- Experience leading major health authority interactions (e.g., pre-NDA/BLA, EOP2)
- Strong leadership experience managing global regulatory teams
- Expertise in GxP and global compliance requirements
- Strategic thinker with strong problem-solving and execution skills
- Excellent communication and stakeholder management skills
- Experience in fast-paced or entrepreneurial environments is a plus

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

BENEFITS WE OFFER:

- 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.
+ Sales - In lieu of annual bonuses, we offer an Incentive compensation program that allows you to earn more - even over plan.
+ Fuel Your Success: Sales Only - 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.
- 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.
- 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. Excludes Sales, Manufacturing, and some Operations positions
- 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%.
- 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.
- 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.
- Enjoy the Holidays: Over the course of the year, Azurity recognizes 13 holidays.
- Invest in Your Education: We support your professional growth with tuition reimbursement for undergraduate and graduate level courses or certifications.
- 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.

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