Global Program Regulatory Director (Remote)
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.
§ 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
§ 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.
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.
§ 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.
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.
• 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.