Azurity Pharmaceuticals · 20 hours ago
Global Head of Regulatory Affairs
Raleigh, NC
Full-time
Hybrid
Director/Executive
15+ years expAzurity Pharmaceuticals is a privately held, specialty pharmaceutical company focused on innovative products for underserved patients. The Global Head of Regulatory Affairs will develop and lead global strategies to maximize regulatory success and oversee multiple complex projects, ensuring compliance with global regulatory requirements.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Oversees regional regulatory leads and staff responsible for ensuring global/regional regulatory strategies are written, reviewed, and executed according to plan
Provides strategic and tactical advice and guidance to allow the timely and efficient conduct of all regulatory projects
Ensures compliance for global regulatory requirements
Is a leader, contributing to cross-functional initiatives and influencing as applicable and demonstrating leadership behaviors
Directs and oversees multiple projects (inclusive of highly complex ones), generally has global/regional oversight for assigned products, this includes oversight to ensure regulatory compliance (e.g. on registration database) by staff and / or vendor
Oversees and accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within area of responsibility
Understands importance of regulatory documents for value and access discussions and partners with access functions to support access applications
Provides leadership and development for direct reports, including those that serve as regional regulatory leads responsible for the design and execution of regional regulatory strategies
Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner
Demonstrates ability to anticipate risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions
Accountable for all global submissions and approvals of project(s) and/or oversees direct reports responsible
Oversees all submissions
Leads and manages meetings and / or interactions with regulatory authorities and agency meetings; or delegates and oversees direct reports and / or vendor; negotiates on behalf of RA team, as necessary
Accountable for working with regulatory regional leads, other functions, and vendors to ensure global regulatory submissions are provided in compliance with local regulations. And to maintain compliance for products
Oversee vendor responsibility for regulatory activities and submissions related to projects within scope
Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner
Qualification
Required
MD, PhD or PharmD in a scientific discipline preferred along with 15+ years of experience in Regulatory Affairs
Proven success in regulatory submissions
FDA, EU, Canada, ROW, and post-marketing experience is a plus with sound knowledge of such principles as GxP's, FDA, and EU guidelines
Previous experience in attending and leading a team to prepare for major health authority interactions (e.g. FDA pre-NDA/BLA, EOP2 meetings, advisory committee meetings and/or EU oral explanations/scientific advice, etc.)
Experience with investigational drugs, including late stage development, and marketed products
Prior managerial experience, with direct supervision of mid- to senior-level regulatory professionals, is highly desirable
Must be a strong leader that creates a vision for group. Inspires and motivates group. Takes stand on important issues in productive, respectful way. Able to mentor and develop skills of staff
Must be strong overall and able to train/develop staff in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies
Strategic thinker, planner, and implementer with excellent organizational skills
Excellent oral and written communication skills and knows how to present data/issues both to a technical and non-technical audience with the ability to write and edit regulatory documents
Able to plan and execute regulatory projects, and proven record of delivering results within business-defined timeframes
Proven ability to work on complex problems where analysis of the situation or data requires an evaluation of intangible variables
Demonstrates potential for a high level of collaboration with others and within global teams
Independent thought, negotiation skills, integrity, and adaptability
Ability to work on own and in virtual setting
MS Office skills with excellent use of excel, PowerPoint and MS Project required
Fluent in English (written and oral)
Preferred
CRO management experience preferred
Recent experience with a smaller entrepreneurial environment is a definite asset
Benefits
Competitive compensation package, including an annual bonus based on company performance
Incentive compensation program
Car reimbursement program and gas card
Excellent medical, dental, vision, and prescription coverage
Hybrid work model
Retirement Savings Plan (401K)
15 vacation days annually + rollover (up to 40 hours)
Five sick/wellness days
Extra week off to spend quality time with your family
13 holidays
Tuition reimbursement for undergraduate and graduate level courses or certifications
Azurity High Five peer recognition platform
Company
Azurity Pharmaceuticals
Azurity Pharmaceuticals is a developer of drug products and technologies to address the needs of patients.
501-1000 employees
H1B Sponsorship
Azurity Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (2)
2023 (4)
Funding
Current Stage
Late StageTotal Funding
$20MKey Investors
Ampersand Capital Partners
2018-03-26Acquired
2015-01-06Private Equity
2014-12-30Series Unknown· $20M
Leadership Team
Vinicius de Lima
Chief Medical Officer
Recent News
Azurity Pharmaceuticals
2025-11-18
Company data provided by crunchbase