AD, Regulatory Advertising & Promotion (Biosimilars) - Remote
Location
Princeton, NJ | United States
Job description
About the role
Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.
Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.
Join us as a Founder of our ‘new’ Sandoz!
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/guidance, 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 guidance, 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.
This position can be based remotely in the U.S. (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager.
The pay range for this position at commencement of employment is expected to be between $174,400 and $261,600/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, 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.
Role Requirements
What you'll bring to the role:
•BA/BS Degree, Advanced degree preferred (MS, MD, PhD, PharmD, or JD).
•Minimum of 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 Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
The future is ours to shape!
Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here:
#Sandoz
Commitment to Diversity & Inclusion:
We 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. Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:
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