Director, Global Regulatory Affairs, Development

The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.

Veloxis Pharmaceuticals is an Asahi-Kasei Group Company based in Cary, NC. Our purpose is to transform transplant medicine as the primary partner to the community of transplant healthcare providers and their patients; our focus is in developing new therapies and programs to help transplant healthcare providers and the patients they treat. Veloxis provides a dynamic and innovative place to work that encourages professional development and embraces diversity. We seek creative, intelligent, action-oriented, and passionate individuals who thrive in a collaborative team environment. If you are interested in being part of a patient-centric company, then we invite you to learn more about the employment opportunities available at Veloxis. Our success is tied to the contribution of every team member, which is why we provide a valuable and competitive compensation package that includes health and insurance benefits, training, and development opportunities, as well as performance-based bonus eligibility.

Company:

Veloxis Pharmaceuticals, Inc.

Job Description:

SUMMARY OF KEY RESPONSIBILITIES:

• Implements and executes Veloxis's global Regulatory strategy.

• Serves as the global regulatory lead on assigned developmental programs. Ensures high-quality collaboration across relevant Veloxis functions (Clinical, CMC, Manufacturing, Quality, etc.) Provides guidance on regulatory issues for development programs.

• Represents and provides leadership on behalf of Veloxis through key interactions with health authorities.

• Ensures compliance of Veloxis's development programs with Regulatory requirements.

• Provides strategic input on key development documents, Clinical protocols, study reports, IBs, INDs, CTAs, and labeling for drug substance and drug products. Provides guidance on planning, writing, and reviewing key dossier documents for submissions globally.

• Ensures high-quality collaboration with other functions to optimize access to patients.

• Remains on the forefront of the relevant science, competitive landscape, and policy, including detailed competitive intelligence, and is viewed as an expert in its application to the Regulatory process.

• If required, manages junior Regulatory staff, including mentoring, setting goals, and providing leadership.

• Selects and effectively manages vendors on behalf of Veloxis for outsourced Regulatory services, ensuring high quality of deliverables within budget and timeline for the project.

REQUIRED QUALIFICATIONS AND SKILLS:

• A solid scientific background: Ph.D., MD, PharmD, MS, or BS.

• 10 years or more experience in the pharmaceutical industry, with significant experience in Regulatory Affairs and related non-clinical and clinical development.

• Extensive experience developing and launching products with successful track record of INDs, NDAs, BLAs, and MAs.

• Understanding of strategic and tactical role and deliverables of global Regulatory strategy in the drug and device development and commercialization process.

• Experience with communicating the Regulatory strategy, issues, and risks in written and verbal format to Regulatory senior leadership team and other governing bodies within the Company.

• Viewed and respected as a leader by peers and others within and outside the organization.

• Excellent general communication skills, with confidence on Regulatory and non-Regulatory topics to internal and external audiences.

TRAVEL REQUIREMENTS: Approximately 10%

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As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.