Manager, Global Program Regulatory - US

Overview

Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? Since 2013, Novartis Gene Therapies (formerly AveXis) has had one focus: bringing change to those devastated by genetic diseases.

The Novartis Gene Therapies culture embraces this mission. As a compassionate and dedicated team, we are enthusiastic about the science behind our work and finding answers to difficult questions. We are dedicated to communities affected by rare diseases, and these patients and families are the motivation for everything we do.

We have built a team with exceptional depth of experience, unified by a common vision; to develop gene therapies with the potential to positively impact the lives of the patients and families devastated by rare and life-threatening neurological genetic diseases. Though we are proud of what we have achieved to date, we remain relentlessly focused on making that vision a reality.

The Manager, Global Program Regulatory - US, provides strategic and operational regulatory direction and supports the global program team (GPT) representative for programs through development, registration and approval/post approval. This role also ensures the execution of regulatory plans in line with global regulatory strategy in close collaboration with the GPT representative.

Responsibilities

Regulatory Strategy:

• Implements regulatory strategy and manages operational activities for assigned on a Global basis.
• Provides input into global regulatory strategy and contributes to Regulatory Functional Plan (RFP) and Seed Document, or their equivalents, including identification of gaps or risks in global strategic plan.
• Partners globally to align on regulatory strategy in order to fulfill business objectives.
• Implements RFP across the globe.
• Works with GPT representative to plan and facilitate presentations to Novartis Gene Therapies (GTx) regulatory boards on regulatory strategy.
• May act as the GPT representative.
• Coordinates and implements regulatory readiness with other line functions, Country Organizations and key opinion leaders.
• Works with GPT representative to interact with regulatory consultants/advisors for strategy input and challenge.
• Represents on or leads sub-team.

Health Authority (HA) Interactions:

• Determines requirements and sets objectives for Health Authority (HA) interactions with GPT representative.
• Interacts directly with HAs as appropriate in meetings with GPT representative.
• Coordinates and plans rehearsals for HA meetings.
• Facilitates preparation and finalization of briefing books.
• Develops and implements plans for timely response to HA requests and coordinates responses.
• May serve as local HA liaison depending on location (e.g., FDA or EMA).

Submissions and Approvals:

• Integrating global strategy into regional submissions worldwide.
• Contributes to identification of issues, gaps, and tradeoffs affecting optimal and timely submission and approval.
• Coordinates, plans, and prepares for submission of dossiers worldwide.
• Review of global dossier summary documents.
• Contributes to development and implementation of plans to avoid/minimize clock stops during submission review.
• Responsible for submission of Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs).
• Participates in negotiations for approvals as required with GPT representative.
• Facilitating timely submission and approval of dossiers with HAs under the guidance of the GPT representative.

Prescribing Information:

• Contributes to the development of the Development Core Data Sheet (DCDS) and Core Data Sheet (CDS) with GPT representative, consistent with development data and commercial objectives.
• Assists with generating local PIs and ensuring that they are integrated with the CDS, and regulatory strategy, and are commercially competitive.
• Contributes to identifying potential label issues/gaps and develops regulatory label negotiation strategy with contingency planning.
• Revise labels as needed to achieve timely HA approval with best possible label based on available data.
• Responsible for ensuring necessary updates or required reviews of local labeling and to capture deviations to maintain alignment with the CDS in conjunction with GL.

Regional Excellence and Compliance:

• Finalization and on time submission of annual reports and renewals worldwide.
• Appropriate entering and quality of product specific attributes in compliance database.
• Ensures regulatory compliance for assigned project and keeps records of all major HA interactions in the validated document management system.
• Ensures quality and compliance with global regulatory requirements and adherence to regulatory internal policies and processes.
• Provide support as needed for non-project related regional excellence activities.
• Promotional/Non-promotional Review:
• Reviews promotional and non-promotional materials and press releases as required and work with GPT representative to ensure messages are consistent with GTx policies and guidelines.
• May have responsibility for leading sub teams.
• Other related job duties as assigned.

Qualifications

• BS in the Life Sciences area with 7 years' experience and demonstrated capabilities; MS with 5 years' experience and demonstrated capabilities; Advanced degree (MD, Ph D, PharmD) with 3 years' experience and demonstrated capabilities preferred.
• Fluency in English as a business language. Additional language is an asset.
• Experience with regulatory submission and approval processes in one or more major regions.
• Experience in a global/matrix environment or cross- functional teams.
• Experience in Health Authority negotiations.
• 3 years' involvement in regulatory and drug/biologic development spanning activities in Phases I-IV in the following areas:
  • Innovation in regulatory strategy.
  • Understanding of post-marketing/brand optimization strategies and commercial awareness preferred.
  • Involvement in a dossier submissions and approvals.
  • HA negotiations.
  • Drug regulatory submission and commercialization in region.
  • Analysis and interpretation efficacy and safety data.
• Regulatory operational expertise.
• Strong interpersonal, communication, negotiation and problem-solving skills.
• Basic organizational awareness (e.g., interrelationship of departments, business priorities).

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.

Novartis Gene Therapies 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.

#LI-EC1