Global Program Regulatory Director Cell & Gene Therapy

Job description

Job Description

Global Drug Regulatory Affairs leader supporting Global Program Team(s) (GPTs) for one or more gene therapies in the ophthalmology or ear-nose-throat (ENT) areas; prior experience with cell and gene therapy development, particularly outside the US, is required. Functions independently with minimal supervision as a core member of the GPT to define and implement the global regulatory strategy for the development, submission, approval and life cycle management of the project(s). Responsible for leading a high functioning global regulatory subteam(s) for the program. May also have full regulatory responsibility for one or more early projects with little or no RA (Regulatory Affairs) sub-team support as appropriate.

Major Accountabilities:

Regulatory Strategy:
• Provide regulatory leadership for assigned project(s).
• Develop high quality and globally aligned regulatory strategies to achieve optimal development objectives and life cycle management plans.
• Ensure that Regional/Country input is sought and incorporated into global regulatory strategy
• Evaluate and clearly communicate to management regulatory risks/gaps and trade-offs for the overall development plan and develop mitigation/contingency plans for identified risks.
• Responsible for development and implementation of the Regulatory Seed Document/Regulatory Functional Plan.
• Leverage regional expertise in executing globally aligned regulatory strategies, and ensure timely sharing of key program changes/information to support appropriate, timely communication to Health Authorities globally.
• Partner with regions to align on regulatory strategy in order to fulfill business objectives.
• Collaborate effectively with external development partners
• Obtain timely consultation with RA line management and Novartis advisory boards on regulatory strategy.
• Lead interactions with regulatory consultants/advisors for strategic input and challenge.
• Represent RA on the GPTs and communicates key program information to regulatory team members and RA management.
• Provide strategic input to GPT and RA team on key Health Authority (HA) documents, obtaining appropriate line endorsement as appropriate.
• Provide strategic input, review and approve clinical study protocols and protocol amendments
• Lead RA activities regarding Novartis safety risk communications for the assigned projects.
• Provide strategic regulatory input into Business Development & Licensing (BD&L) Due Diligence evaluations as required.

HA Interactions:
• Develop global regulatory strategy and plans for Health Authority interactions as appropriate.
• Contribute to and review HA responses, as required, to ensure appropriate, consistent and complete answers to any HA questions. Ensure responses are in line with development strategy.
• May lead interaction with HAs during key HA meetings
• Provide leadership by supporting the Global Program Regulatory Managers (GPRMs) in their direct interactions with HAs as appropriate.

Submissions and Approvals:
• Lead the global submission planning process, including potential Advisory Committees.
• Lead regulatory submission process throughout project lifecycle on behalf of GPT. This includes oversight of submission plan, generation and sign-off of key regulatory/response components.
• Proactively address issues, gaps, options and trade-offs for the development plan to increase the probability of an optimal and timely submission and approval.

Prescribing Information:
• Responsible for developing the Development Core Data Sheet (DCDS) and the first CDS with input from the RA Global Labeling (GL) member, GPT, contributing line functions and selected country affiliates, consistent with development data and objectives of the Target Product Profile (TPP). Responsible for ensuring necessary updates or required reviews for the CDS in conjunction with RA GL.
• Accountable in conjunction with RA GL for maintaining the CDS along with Novartis core product information documents though product life cycle.
• Guide and support GPRMs and CPOs to ensure consistency and compliance with CDS in partnership with RA GL.
• Identification of potential label issues/gaps and develop global regulatory label negotiation strategy with contingency planning.
Regional Excellence and Compliance:
• Ensure compliance with global regulatory requirements and adherence to regulatory internal policies and processes, and coordinate regulatory compliance activities at a global level.
• Provide support as needed for non-project related regional excellence activities.
Promotional/Non-promotional Review:
• If assigned as a local regulatory representative, conduct RA review of promotional and non-promotional materials in accordance with Novartis policies and guidelines.
• Reviews promotional and non-promotional materials and press releases as required and ensures messages are consistent with NP4 guidelines.
Managerial
• Effective matrix management of regulatory team(s) consisting of GPRMs and other RA line functions, providing, to the extent possible, mentorship and opportunities for growth and development.
• Serve as role model embracing Novartis Values and Behaviors. Lead by example.
Position Title

Global Program Regulatory Director Cell & Gene Therapy

Desired profile

Minimum requirements

Education:

Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, PhD, PharmD) preferred.

Language:

Fluent in English as a business language. Additional language is an asset.

Professional Experience:

Minimum 6-8 years of regulatory and drug/biologic development experience in Europe and Asia or Latin America. Prior experience with cell and gene therapy development, is a requirement, and ex-US and later-phase development experience is highly desirable. Ophthalmology expertise is a plus. Experience will ideally span activities in Phases I-IV in most or all of the following areas:

• Innovation in regulatory strategy.
• Prior history with post-marketing/brand optimization strategies and commercial awareness
• Major involvement in a CTD/MAA/NDA submission and approval.
• Leadership role in HA negotiations in multiple regions.
• Proven success in global drug regulatory submissions.
• Proven ability to analyse and interpret efficacy and safety data.
• Regulatory operational expertise.
• Minimum 2-5 years of demonstrated leadership and accomplishment in all aspects of regulatory affairs in a global/matrix environment in the pharmaceutical industry.
• Global matrix management people management experience desirable.
• Good management, interpersonal, communication, negotiation and problem solving skills.
• Organizational awareness (e.g., interrelationship of departments, business priorities), including experience working cross functionally and in global teams.
Job Type

Full Time
Country

Switzerland
Work Location

Basel
Functional Area

Research & Development
Division

Global Drug Development
Business Unit

REG AFFAIRS GDD
Employment Type

Regular
Company/Legal Entity

Novartis Pharma AG