AD Regulatory Affairs
Company: Novartis Group Companies
Posted on: January 25, 2023
AD Regulatory Affairs
500 million patients were touched by Sandoz generic and biosimilar
medicines in 2020 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.
Directs the development of submission of product registration,
progress reports,supplements, amendments, and/or periodic
experience reports. Provides strategic product direction to teams
on interaction and negotiates evidence with regulatory
agencies.Interacts and negotiates with regulatory agency personnel
in order to expedite approval of pending registration and answers
any questions. Serves as a regulatory liaison on the project team
throughout the product lifecycle. Ensures rapid and timely approval
on of new drugs, biologics/biotechnology and/or medical devices and
continued approved status of marketed drugs or medical devices.
Serves as regulatory representative to marketing or research
project teams and government regulatory agencies. Provides advice
to development and/or marketing teams on manufacturing changes,
line extensions, technical labeling, appropriate regulations and
interpretations. Coordinates, reviews, and may prepare reports for
* Is responsible for implementing regulatory strategy and managing
operational activities for assigned major/ large regions.
* Provides input into global regulatory strategy and contributes to
* Plan (RFP) and Seed Document, or their equivalents, including
identification of gaps or risks in global strategic plan for
* Partners with regions to align on regulatory strategy in order to
fulfil business objectives
* Implements RFP across assigned regions.
* Determines requirements and sets objectives for Health Authority
(HA) interactions with DRA GPT representative and/or GTAL.
* Facilitates preparation and finalization of briefing books and
contributes to preparation of summary documents.
* Develops and implements plans for timely response to HA requests
and coordinates responses.
* May lead negotiations for regional approvals independently or
with DRA GPT representative and/or GTAL.
* Responsible for facilitating timely submission and approval of
dossier with HAs under the guidance of the DRA GPT representative
* Contributes to and often leads the development of departmental
goals and objectives.
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.
* PhD, PharmD or BS in Science major. Advanced degree is
* 7+ years of pharmaceutical and/or biotech development related
experience including a minimum of 5 years of regulatory affairs
strategy experience, preferably biologics experience. Preferred
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
Imagine what you could do here at Sandoz!
COMMERCIAL OPS NA SZ
Research & Development
Keywords: Novartis Group Companies, Trenton , AD Regulatory Affairs, Other , Princeton, New Jersey
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