Sr. Manager, Regulatory Affairs (Remote)

**378516BR** **Job ID:** 378516BR **About the role:** 2023 will potentially see Sandoz become a standalone organization! Already a global market leader in Generics and Biosimilar medicine, this is an exciting, once-in-a-career opportunity to set our own path forward as an independent, purpose-driven organization, and as the founders of a new Sandoz, this is a time of immense opportunity for us all, both professionally and personally! Together we will shape the future of Sandoz… are you ready to make a difference? As the Sr. Manager, Regulatory Affairs, you will support one or more biosimilar/biotech projects, and compile and prepare high quality regulatory documentation for complex global regulatory submissions worldwide. You will be responsible for executing and implementing the regulatory strategy and providing regulatory and strategic support of assigned biosimilar/biotech project(s) and tasks through development, registration, and approval/post approval. You will work independently under limited supervision to provide strategic and operational regulatory direction and support the Regulatory Affairs global program team (GPT) representative. Your additional responsibilities include, but not limited to: •Proactively identify and highlight potential regulatory gaps besides providing risk mitigation and minimization measures during strategic evaluations •Provide input and collaborate with relevant stakeholders with a focus on implementing strategies, meeting timelines and formal requirements, and assuring congruency and compliance •Be an active member of the regulatory project (sub)team and where applicable, may act as representative of regulatory functions in the global project team(s) •Lead the preparation of responses to regulatory relevant queries from various stakeholders and directly interact with regulatory authorities and/or with regulatory functions globally. 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. \n\n\n\n **Position Title:** Sr. Manager, Regulatory Affairs (Remote) **Role Requirements:** What you’ll bring to the role: •An advanced degree in life sciences/healthcare (PharmD/PhD) or Master’s degree with relevant industry experience •Minimum of 5+ years’ experience in regulatory affairs in a pharmaceutical/biotech company •Good understanding of US FDA regulatory requirements for drug development and experience with direct liaison with FDA. Experience with other Health Authorities a plus •Advanced ability to interpret scientific data and to construct persuasive regulatory documents •Good communication skills and the ability to work effectively in a matrix setup •Experience in leading functional sub teams is preferred This position can be based remotely in the U.S. (but 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. This position will require minimal travel, as business needs require. Commitment to Diversity & Inclusion: Sandoz is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. 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 send an e-mail to tas.nacomms@novartis.com or 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. Why Sandoz? Almost 500 million patients were touched by Sandoz generic and biosimilar medicines in 2022 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. We are at a pivotal moment in our history giving us the freedom to invest in our future so we can continue to help millions of people access affordable high-quality medicines. Together we will shape the future of Sandoz, building an organization from the ground up and in return, experience an ambitious 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: https://talentnetwork.novartis.com/sandoztalentpool **Job Type:** Full Time **Country:** USA **Work Location:** Princeton, NJ **Functional Area:** Research & Development **Division:** SANDOZ **Business Unit:** Sandoz Global Development **Employment Type:** Regular **Company/Legal Entity:** Sandoz Inc **Commitment to Diversity & Inclusion::** _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._ **Shift Work:** No **Early Talent:** No

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