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Associate IV, Regulatory Affairs Labeling

Princeton, New Jersey, United States
Closing date
Dec 3, 2022

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Other, Legal/Regulatory Affairs
Position Type
Full Time
Organization Type
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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.

Responsible for supporting Sandoz’ business by preparing, reviewing, and submitting high quality and compliant regulatory labeling submissions to the FDA based on Reference Listed Drug Labeling per FDA guidelines and regulations, and Sandoz internal policies and procedures

Your responsibilities include, but are not limited to:

• Responsible to create and maintenance of labeling for Abbreviated New Drug Applications (ANDA), Biologics License Application (BLA), New Drug Application (NDA) and Authorized Generics products. This includes common labeling components such as package insert, patient information leaflet, medication guide, container label etc.
• Responsible for the creation and maintenance of labeling submission packages for FDA submission, which include file in different formats such as doc, docx, pdf and SPL.
• Work collaboratively to implement label changes, e.g., with manufacturing, for external web site, pharmacovigilance, marketing, legal, supply chain and FDA to complete drug listing/ de-listing.
• Attention to detail, coaching of more junior associates; shares knowledge and successful strategies. Identifies and exploits opportunities for improving knowledge.
• Represents organization in global and local initiatives; engages with cross-functional teams and manages projects Influence without authority.
• Embraces digital and technological strategies to improve outcomes. Identifies opportunities and assess checks with effectiveness.

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.

Minimum Requirements

What you'll bring to the role:

• Bachelor's or Associates degree in a scientific discipline.
• Bachelor’s degree plus a minimum of 7 years in the pharmaceutical industry with 5 of those years in regulatory affairs labeling.
• Associates degree plus a minimum of 10 years pharmaceutical industry experience, with at least
5 years in regulatory affairs labeling
• Excellent interpersonal communication, collaborative teamwork, and negotiation skills
• Demonstrated ability to analyze and correct processes and/or system issues of a broad scope using independent judgment
• Ability to build and leverages network to proactively address challenges and champion improvements

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:

The pay range for this position at commencement of employment is expected to be between $92,800 and $139,200/year; however, while salary ranges are effective from 1/1/22 through 12/31/22, 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 [email protected] 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.
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