Associate Director, Regulatory Affairs US Biopharma

304817BR304817BRJob Description:2015 was the year that Sandoz got approval for the first biosimilar in the United States. Over 20 years of experience in biosimilar development have equipped us with extensive knowledge and world-class expertise and capabilities in the development, manufacturing and commercialization of biosimilar medicines to the healthcare community and patients worldwide. This opportunity is waiting for you to contribute to Sandoz success story in the area of biosimilar toward the Talent Acquisition & Staffing – EVP 2019 Business Use Only 18 future, at the same time it becomes also the right step up in your career within clinical development!The Associate Director Regulatory Affairs US Biopharma is an exciting opportunity to be a Regulatory lead at Sandoz in biosimiliars; an important area of drug development bringing patients and prescribers affordable medicines. The individual will have the opportunity to be the direct contact with various agencies within the FDA. Manage multiple products across different therapeutic areas. Experience drug development across at all phases of development, including post-approval and life cycle management. An important component of the work is to develop US regulatory strategies and understand precedents leading to strong US filings. The individual will work closely with the global Biopharm Regulatory Affairs (BRA) Leads to provide critical US perspective for regulatory strategies (precedents), provide regulatory guidance, critically review documents for submission to FDA, and oversee the execution of the US regulatory strategy in line with the project team’s goals.Your Key Responsibilities: Acts as a FDA liaison contact for project issues. Leads FDA project meetings and major label negotiations with FDA. Represents US BRA as a member of the cross-functional project team to provide US regulatory guidance throughout development, launch and post-approval process.o Understand US regulatory guidance including technical/ CMC guidance relat-ing to biosimilar products and understand the impact on current and future submissions.o Ensures the overall regulatory strategy aligns with the target product profile (TPP), US specific needs, US biosimilar regulatory environment. Identifies and assesses regulatory risks associated with product development and defines strategies to mitigate risks.o Reviews reports from contributing functions and provides comments to assure accurate and complete documents for FDA submissions. Maintain compliance for assigned products Acts as a single point of contact for the business for US regulatory issues on assigned projects. Interacts with key personnel (scientific, clinical, and commercial) within Sandoz and external partners to ensure timely and accurate regulatory compliance. Responsible for coordinating all aspects of regulatory submissions relevant to assigned projects and programs, including IND, BLA, NDA, 510(k), product line extension applica-tion, change control supplements and labeling supplements.nnnn{#400,300#}#/video#]Position Title:Associate Director, Regulatory Affairs US BiopharmaMinimum requirements:What Your Bring to the role: Bachelor’s Degree in Science area required Minimum of 10 years regulatory/pharma experience required Strong understanding of IND process required Previous submission experience required Biosimilar submission experience preferred Previous experience interacting with the FDA required (working with FDA PM or labeling) Experience in multiple development phases requiredJob Type:Full TimeCountry:USAWork Location:Princeton, NJFunctional Area:Research & DevelopmentDivision:SANDOZBusiness Unit:COMMERCIAL OPS NA SZEmployment Type:RegularCompany/Legal Entity:Sandoz IncEEO Statement: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 any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.Shift Work:No