2015 was the year that Sandoz got approval for the first biosimilar in the United States! Over 20 years of experience in biosimilar development and 8 biosimilars licensed globally have equipped us with extensive knowledge and capabilities in the development, manufacturing and commercialization of biosimilars to increase access to life-saving medicines to patients worldwide. This opportunity is waiting for you to contribute to Sandoz’ success story in the future and at the same time it becomes also the right step up in your career.
The Associate Director of Regulatory Advertising and Promotion is responsible for strategic leadership of regulatory reviews and guidance relating to promotional activities for assigned products.
Your responsibilities will include, but are not limited to:
• Serving as a regulatory reviewer for assigned products. Ensures regulatory compliance while effectively managing business risks.
• Ensures that strategic regulatory subject matter expertise is provided on advertising and promotional materials/activities for assigned products in accordance with business goals and objectives, FDA regulations/guidances, PhRMA guidelines and company policy
• Reviews relevant medical and clinical development non-promotional materials in accordance with company policies.
• Primary liaison with Office of Prescription Drug Promotion (OPDP) regarding advertising and promotion for assigned products, including authoring responses to OPDP letters
• Monitors US regulatory promotional environment by staying up-to-date on FDA regulations and guidances, reviewing untitled and warning letters to pharmaceutical companies published by OPDP, and by attendance at major FDLI, DIA, and other industry/FDA meetings (when appropriate)
• Participates in due diligence activities for potential licensing and acquisition opportunities that are being evaluated by the company.
• Responsible for researching, review and interpretation of related product approvals, current regulatory guidance documents and recent public Advisory Committee proceedings, to support the development of optimal regulatory strategies to ensure complete submissions and achievement of target product labeling
Please note that this role would not provide relocation as a result. If associate is remote, all home office expenses and any travel/lodging to Princeton, NJ for periodic live meetings will be at the employee’s expense. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager.
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.
What you'll bring to the role:
•BA/BS Degree, Advanced degree preferable (MS, MD, PhD, PharmD, or JD).
•Minimum 7 years regulatory experience.
•Excellent understanding of US regulations for drug promotion/advertising and experience in the regulatory review of prescription drug advertising and promotion including product launches
•Proven ability to provide strategic direction and innovative, forward thinking regulatory guidance
•Proven ability to analyze and interpret efficacy and safety data
•Demonstrated experience in working with others to achieve organizational objectives including the ability to anticipate and adapt, own and or/work group tactics to support changing business needs
•Desired talent must have a collaborative mindset and curious nature
Why consider Sandoz?
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.
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 $151,200 and $226,800/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