Global Drug Regulatory Affairs leader supporting Global Program Team(s) (GPTs). 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 DRA sub-team support as appropriate.
Regulatory Strategy :
Provide regulatory leadership to assigned project(s).
Develop high quality and globally aligned regulatory strategies to achieve optimal development objectives and life cycle management plans.
Ensure that Regional / CPO 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 fullfill business objectives.
Obtain timely consultation with DRA line management and Novartis advisory boards on regulatory strategy.
Lead interactions with regulatory consultants / advisors for strategic input and challenge.
Represent DRA on the GPTs and communicates key program information to regulatory team members and DRA management.
Provide strategic input to GPT and DRA team on key HA documents, obtaining appropriate line endorsement as appropriate.
Provide strategic input, review and approve clinical study protocols and protocol amendments
Lead DRA activities regarding Novartis safety risk communications for the assigned projects.
Provide strategic regulatory input into BD&L Due Diligence evaluations as required.
HA Interactions :
Develop global regulatory strategy and plans for Health Authority (HA) 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 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 DRA 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 DRA GL.
Accountable in conjunction with DRA 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 DRA 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 DRA 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.
Effective matrix management of regulatory team(s) consisting of GPRM’s and other DRA 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.
Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred.
Fluency in English as a business language. Additional language is an asset.
Minimum 6-8 years of regulatory and drug / biologic development experience, ideally spanning 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 analyze 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.