350174BR
8月 03, 2022
USA
About the Role
2015 was the year that Sandoz got approval for the first biosimilar in the United States. Over 20 years of experience in biosimilar development have equipped us with extensive knowledge and world-class expertise and capabilities in the development, manufacturing and commercialization of biosimilar medicines to the healthcare community and patients worldwide. This opportunity is waiting for you to contribute to Sandoz success story in the area of biosimilar toward the future, at the same time it becomes also the right step up in your career!
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
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.
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.
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.
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.
Managerial
§ 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.
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
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.
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.
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.
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.
Managerial
§ 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.
Diversity & Inclusion / EEO
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Role Requirements
Education
Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred.
Experience:
§ 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.
Why Sandoz?
500 million patients were touched by Sandoz generic and biosimilar medicines in 2021 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Sandoz!
Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred.
Experience:
§ 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.
Why Sandoz?
500 million patients were touched by Sandoz generic and biosimilar medicines in 2021 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Sandoz!
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
COMMERCIAL OPS NA SZ
USA
Princeton, NJ
Sandoz Inc
Research & Development
Full Time
Regular
No
