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.

As part of the Regulatory Affairs Team, the Associate Director, Labeling will liaise with all members of the leadership team and external business partners such as Commercial Operations, Strategic Planning, FDA and Global. The Associate Director, Labeling will report to the Director, Regulatory Affairs at the Sandoz US Headquarters site in Princeton, NJ.

Your Responsibilities include, but are not limited to:

• Create, update and maintain labeling for Abbreviated New Drug Applications (ANDA), Biologics License Application (BLA), New Drug Application (NDA) and Authorized Generics products. Common labeling components are package insert, patient information leaflet, medication guide, container label etc.

• Manage labeling team including managing workloads, processes, ensuring compliance with 21CFR by the team, annual review process etc.

• Create, update and maintain labeling submission package for FDA submission, which include file in different formats such as doc, docx, pdf and xml.

• Liaise and collaborate with the FDA labeling review branches, labeling art vendors and all other up and down stream functions that contributes and utilize labeling.

• Work cross-functionally 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.

• Review and approve promotional advertising pieces and assure that evolving standards for Track and Trace, electronic labeling are integrated into internal systems.

• Development/Maintenance of electronic tracking systems for labeling updated, RLD tracking and submission status with goal of harmonized approach with Global for all products including BD&L license contacts.

• Development of labeling related SOPs and work instructions to drive process harmonization, consistency and compliance with regulations.

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:

• BS / BS Degree or equivalent experience (min 10 years industry exp)
• PharmD degree preferred
• People management experience required
• Minimum of 8 years of generics labeling experience.
• Promotion / advertising experience preferred
• Regulatory submission experience in ANDA, NDA and INDs
• Knowledge of cGMP
• Expertise in pharmaceutical labeling regulations, and in pharmaceutical promotional and advertising regulations
• Detail oriented, well organized, and good planning skill
• Excellent communication skills

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 $130,400 and $195,600/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

SANDOZ

COMMERCIAL OPS NA SZ

USA

Princeton, NJ

Sandoz Inc

Research & Development

Full Time

Regular

No

No