Manager, Regulatory Affairs Biosimilars
Company: Novartis Group Companies
Location: Princeton
Posted on: January 26, 2023
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Job Description:
346763BR
Manager, Regulatory Affairs Biosimilars
Job Description
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.
An exciting opportunity to join Sandoz biosimilars; an important
area of drug development bringing patients affordable medicines.
Manage multiple products across different therapeutic areas. Be a
contributor of regulatory strategies in drug development in all
phases of development, including post-approval and life-cycle
management. The individual will work closely with US regulatory
affairs associates.
Your responsibilities include, but are not limited to:
Understands US regulations, guidance's, and is aware of precedents:
Provides input into global regulatory strategy of marketed products
LCM, and identifies gaps or risks for FDA review
* Understands biosimilar, interchangeability and technical
regulatory guidance's
* Possibly serve as FDA liaison depending on experience
* Coordinates and implements regulatory readiness with other line
functions
* Submissions:
- Responsible for coordinating US regulatory submissions, including
IND, sBLA product line extension applications, change control and
labeling supplements.
- Insure high quality submissions
- Help set up rapid response team to answer US information
requests
- Contribute US labeling and artworks preparation
* Executes and manages operational activities for assigned
projects
* Contributes to development of departmental goals and
objectives
* Maintain compliance for assigned products (annual reports, DSURs,
HA correspondence, monitor reference product label updates, adheres
to SOPs
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.
Minimum requirements
What you'll bring to the role:
* Bachelor in a science required
* 1-5 years regulatory or relevant experience
* Experience in global matrix environment preferred
* Regulatory operational experience
* Ability to multi-task across various products, operational
expertise
* Organizational awareness (interdepartmental relations, business
priorities)
Why Sandoz?
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!
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 potential.
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: https://talentnetwork.novartis.com/network
The pay range for this position at commencement of employment is
expected to be between $118,400 and $177,600/year; however, while
salary ranges are effective from 1/1/23 through 12/31/23,
fluctuations in the job market may necessitate adjustments to pay
ranges during this period. Further, final pay determinations will
depend on various factors, including, but not limited to
geographical location, experience level, knowledge, skills and
abilities. The total compensation package for this position may
also include other elements, including a sign-on bonus, restricted
stock units, and discretionary awards in addition to a full range
of medical, financial, and/or other benefits (including 401(k)
eligibility and various paid time off benefits, such as vacation,
sick time, and parental leave), dependent on the position offered.
Details of participation in these benefit plans will be provided if
an employee receives an offer of employment. If hired, employee
will be in an "at-will position" and the Company reserves the right
to modify base salary (as well as any other discretionary payment
or compensation program) at any time, including for reasons related
to individual performance, Company or individual department/team
performance, and market factors.
Accessibility and reasonable accommodations: The Novartis Group of
Companies are committed to working with and providing reasonable
accommodation to individuals with disabilities. If, because of a
medical condition or disability, you need a reasonable
accommodation for any part of the application process, or in order
to perform the essential functions of a position, please send an
e-mail to tas.nacomms@novartis.com call +1 (877)395-2339 and let us
know the nature of your request and your contact information.
Please include the job requisition number in your message.
https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings
Division
SANDOZ
Business Unit
COMMERCIAL OPS NA SZ
Country
USA
Work Location
Princeton, NJ
Company/Legal Entity
Sandoz Inc
Functional Area
Research & Development
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
Yes
Keywords: Novartis Group Companies, Trenton , Manager, Regulatory Affairs Biosimilars, Executive , Princeton, New Jersey
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