Summary
About the Role
Major accountabilities:
Key Requirements:
Regulatory Strategy
Provide input to global program regulatory strategy, including regulatory designations & innovative approaches and may provide global RA leadership for specific part of the program or act as lead for a program of limited complexity.
Coordinates regulatory readiness with other line functions, Country Organizations & Regions, representing RA or leads in regional RA or cross-functional activities providing strategic input into cross functional deliverables.
Contributes to the development and maintenance of key documents, determines the requirements and coordinates the activity for HA interactions. May lead or serve in HA meetings or local HA liaison respectively.
Regulatory Submissions
Leads planning, preparation and submission of clinic trails, and the implementation of defined global registration strategy into regional submissions worldwide with country organsiations.
Coordinates, plans and prepares for submission of initial registrations and post approval applications, and the preparation, review and maintenance of local product information as assigned.
Lead regulatory activities during HA reviews, responding to questions and HA interactions.
Regulatory Excellence & Compliance
Ensures timely RA input and submission of regulatory compliance and maintenance reports, maintaining regulatory information in compliance databases and document management systems.
May serve as a RA subject matter expert and assume a mentoring role.
Life Cycle Management
You may also focus on one of the following key areas of activity:
Maintenance – preparation of selected global regulatory submissions.
Portfolio Transformation – e.g. streamlining activities, divestment/ integration, portfolio transformation and manufacturing transfer.
Business & Operational Excellence – collating, for example, registration samples, CPPs etc. to support submissions.
NB: if the Senior Global Program Regulatory Manager acts as a Team Lead, manage several direct reports.
Your Experience:
Science based bachelors or advanced degree, plus advance understanding of pharmaceutical development, clinical trails.
Awareness of post marketing/ brand optimization strategy, with track record of involvement in regulatory or pharmaceutical development in Phases I – IV, in multiple geographies.
Strong interpersonal skills and experience working in a complex, cross functional organization and leading cross function teams.
Compliance and Quality mindset.
Fluency in English.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? : https://www.novartis.com/about/strategy/people-and-culture
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Join our Novartis Network:
Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
