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Director/Sr Director Regulatory Affairs

Company: GQR Global Markets
Location: Hackensack
Posted on: October 23, 2019

Job Description:

This opportunity is with a mid-sized biotech developing a strong pipeline in CNS and Oncology. They have a strong financial backing as a subsidiary of a larger institution. They already have an approved product and have a PDUFA reading set for Q4 of 2019! This individual will lead US and Global Regulatory Strategy and be a part of an existing Regulatory team with a stong reputation. You will partner directly with the VP of Regulatory Affairs and help to create and drive the regulatory strategy to grow the regulatory team and bring their products to the clinic, and to commercialization. --KEY TASKS AND RESPONSIBILITIES: --- Develop and implement strategic regulatory plans based on clinical and nonclinical requirements and data --- Identify, assess and communicate regulatory risks --- Help the preparation and submission of IND, NDA, MAA, and relevant filings -- --- Collaborate with regulatory team members and cross functional teams in clinical, quality and manufacturing --- Lead interactions and relationships with regulatory and health authorities --SKILLS AND ATTRIBUTES: --- Experience with a broad range of drug development programs --- Excellent attention to detail --- Track record working with all phases of clinical development --- Strong working knowledge of FDA regulations, requirements and pathways --- Excellent written, verbal and presentation skills; experience in filing IND, NDA/BLA, sNDA, CTA, MAA WHAT CAN MY CLIENT OFFER YOU --- Competitive package including base/bonus --- MANAGEMENT EXPERIENCE - this position will have 2 direct reports --- 401K matched dollar-for-dollar up to 5% --- Medical/Dental/Vision FREE for you AND family --- Generous company holidays and PTO --- Strong career progression and opportunity for promotion --- Competitive vacation -- --- And much more to come.... EDUCATION AND EXPERIENCE: --- M.S./B.S. Required; PhD a plus --- 7+ years of experience, (domestic and global preferred), leading regulatory affairs in the pharmaceutical/biotech industry. Experience with therapeutics is required. If you're passionate about the opportunity to help build a growing Regulatory team and are looking for a place invested in YOUR career progression, please email your CV to katie.litwin@. Qualified candidates will be contacted with more info!

Keywords: GQR Global Markets, Clifton , Director/Sr Director Regulatory Affairs, Executive , Hackensack, New Jersey

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