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Form of workSandoz 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!
As the Associate Director/Director of Regulatory Affairs, you will direct a team within Regulatory in the development of submissions for New Drug and Abbreviated New Drug Applications for Generic Medicines. The level of the position will be commensurate with experience. This role will work directly with the development and maintenance teams on the product registrations, through FDA communication and review process, amendments, supplements, and annual reports. You will provide strategic product direction to cross functional teams with regards to Regulatory requirements and negotiate evidence with regulatory agencies. Interact and negotiate with regulatory agency personnel to expedite approval of pending registrations and answer any FDA related questions. Serves as a regulatory liaison on the project team from development throughout the product lifecycle. Ensures rapid and timely approval of new drugs, abbreviated new drugs and continued maintenance activities of marketed drugs. Serves as regulatory representative to marketing or research project teams and government regulatory agencies. Provides advice to development and/or manufacturing sites on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations. Coordinates, reviews, and may prepare submissions.
Additional responsibilities include, but not limited to:
Preparation of regulatory new drug submissions (ANDA/NDAs), amendments, supplements, and annual report submissions.
Effectively manage a team of regulatory associates to handle a dedicated portfolio from beginning to end
Properly and compliantly evaluate proposed changes and provide regulatory input as needed for the US market
Effectively manage submission preparation to ensure implementation dates and approval goal dates are met.
Contribute to performance and KPIs of the team to deliver agreed upon targets and objectives and supports reporting.
Provide internal and external development and maintenance sites, business development partners, and manufacturing business partners with proper strategic alignment and change evaluations to plan and implement registration activities and to meet commitments and requests from FDA including deficiency letters.
Ensure that the escalation process to next or higher-level management is followed.
Provide regulatory consultancy for products and technical operations.
Ensure proper data management.
This opportunity is located at the Sandoz Princeton, NJ site. Sandoz follows a hybrid approach to work location.
Preference will be given to local candidates not requiring relocation.
The pay range for this position at commencement of employment is expected to be between $174,400 and $261,600/year for an Associate Director level and $201,600 and $302,400 for Director level; 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.
On September 30, 2021, Sandoz entered into a 5-year Corporate Integrity Agreement. Certain positions will have responsibilities to support the execution and adherence to CIA obligations, CIA-related deliverables, and any relevant audit, monitoring or Independent Review Organization (IRO) remediation.
