Senior Manager, Global Regulatory Affairs

Overview

Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission.

AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene.

AveXis is seeking a Senior Manager, Global Regulatory Affairs that will serve as the dedicated regulatory point of contact for early and late-stage products for the international markets (APAC, Japan, Latin America, Canada, Middle East, India, Russia/CIS, Africa). Provide Regulatory Affairs (RA) support to local and area commercial colleagues to advance global and regional priorities.

Responsibilities

• Facilitate the development and timely execution of the submission/approval strategy for the international markets.
• Oversight of RA filings required for clinical trials through to submission of Marketing Authorization applications. Including the planning and preparation of dossiers and execution of these submissions.
• Prepare and participate in regulatory Health Authority meetings in partnership with affiliate regulatory, to meet business and regulatory objectives.
• Cross-functionally manage the preparation of regulatory response documents to address Health Authority deficiency questions.
• Work in close collaboration with the commercial organization to align registration and launch strategies.
• Build strong relationships with affiliate regulatory affairs to improve communication and increase efficiencies.
• Ensure alignment across the regulatory and business functions (CMC, nonclinical, clinical, and commercial).
• Develop and negotiate overall plans regarding safety, efficacy, and quality to assure viability for global or regional registrations.
• Accountable for ensuring that regulatory submissions meet appropriate standards and content requirements.
• Identify risk areas and develop alternative courses of action including anticipation of regulators' responses through scenario planning and development of contingency plans.
• Assist manufacturing and supply chain on sourcing strategies and import/export issues.
• Prepare and present updates to regulatory strategy and timelines to Sr. Leadership.
• Provide regulatory support for products in the international markets after Marketing Authorization is obtained.
• Travel: approximated 20%

Qualifications

• Bachelor's degree in pharmacy, biology, chemistry, pharmacology or related science subject required.
• At least 8-10 years' experience with increasing responsibility in the pharmaceutical or biotechnology industry and 5-8 years' experience in regulatory affairs.
• Sound basis of scientific (training/communications) knowledge.
• Knowledge of regulations, current industry practices, and strong experience with interpretation and application.
• Able to develop and execute complex regulatory strategies across one or more regions.
• Excellent written and verbal communication, presentation, and facilitation skills.
• Strong negotiation and project management skills.
• Experience with rare diseases preferred.
• Broad experience across multiple functional areas desired.

The level of this position will be based on the final candidate's qualifications.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.

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