Global Program Regulatory Director
Company: Novartis Group
Posted on: January 12, 2022
26 major approvals. 13 major submissions. 2,000 associates
worldwide. That was Regulatory Affairs in 2020. We are a culturally
diverse, global team of talented professionals seeking to leverage
the voices of our patients in our approach to bringing potentially
life-changing therapies to people who need them. Novartis has a
robust pipeline, including possible treatments for rare disease
conditionals with unmet needs.
We are expanding our global team and encourage you to consider a
career in Regulatory Affairs at Novartis. Working collaboratively
and interactively thanks to our technology, we have been as
connected as ever-OneRA as we call it. We pride ourselves on our
patient-focused mindset and dedication, which allow us to work
closely with colleagues, share knowledge, and strive to reimagine
medicine. Read on to learn what you could do as part of our closely
** This role can either be based at the Cambridge, MA or East
Hanover, NJ sites**
The Global Program Regulatory Director (GPRD) is a 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), including drug, digital applications and medical
devices, in close collaboration with the Global Therapeutic Area
Lead (GTAL), as appropriate. Responsible for leading a high
functioning global regulatory subteam(s) for the program. May also
have full regulatory responsibility for one or more projects with
little or no RA sub-team support as appropriate.
Your Responsibilities Include, but are not limited to:
--- Provide regulatory leadership to assigned project(s)
--- Develop high quality and globally aligned regulatory strategies
to achieve optimal development objectives and life cycle management
--- 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 program
changes/information to support timely communication to Health
--- Partner with regions to align on strategy in order to fulfill
--- Acquire timely consultation with RA line management and
Novartis advisory boards on strategy
EEO Statement 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. What You'll Bring to the role:
---Science based BS or MS with requisite experience and proven
capability. Advanced degree (MD, Ph D, PharmD) preferred.
--- 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.
- 2-5 years of proven leadership and accomplishment in all aspects
of regulatory affairs in a global/matrix environment in the
- Global matrix management experience desirable.
- Experience in medical device and digital device registration is
- 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, and collaborating effectively
with external development partners.
Why consider Novartis?
769 million. That's how many lives our products touched in 2019.
And while we're proud of that fact, in this world of digital and
technological transformation, we must also ask ourselves this: how
can we continue to improve and extend even more people's lives?
We believe the answers are found when curious, courageous and
collaborative people like you are brought together in an inspiring
environment. Where you're given opportunities to explore the power
of digital and data. Where you're empowered to risk failure by
taking smart risks, and where you're surrounded by people who share
your determination to tackle the world's toughest medical
Imagine what you could do at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. 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
Join our Novartis Network:
If this role is not suitable to your experience or career goals but
you wish to stay connected to learn more about Novartis and our
career opportunities, join the Novartis Network here:
Keywords: Novartis Group, Cambridge , Global Program Regulatory Director, Executive , Cambridge, Massachusetts
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