• Vice President, Regulatory Affairs

    Location US-NJ-Bridgewater
    Posted Date 6 days ago(11/9/2018 4:49 PM)
    ID
    2018-2189
    Company
    Kashiv Pharma LLC
  • Overview

    Kashiv Pharma, LLC is an emerging pharmaceutical research and drug delivery company focused on developing innovative technologies, improved medicines and life cycle management products. Kashiv also offers contract research and development services to pharmaceutical clients in need of formulation and analytical development expertise and/or clinical supply manufacture. At the forefront of our dynamic new organization, the Vice President, Regulatory Affairs will be responsible for building and leading a Regulatory Affairs department for the evolving needs of Kashiv. Candidate will be responsible for developing the strategic plan for obtaining approval for products in the pipeline, and for developing strong relationships with the FDA and other global regulatory agencies. 

    Responsibilities

    Principal Duties/Responsibilities 

     

    • Develop global regulatory strategies to gain earliest possible regulatory approval in US and other international markets with product labelling that sets a high hurdle for any competitors in the field
    • Develop effective working relationships with FDA, EMEA, and other regulatory authorities, such as coordinating activities for meetings and leading approval negotiations
    • Manage the compilation, submission and maintenance of INDs, BLA's and amendments
    • Build and effectively lead high-performing Regulatory team
    • Identify gaps in product development plans that may pose regulatory issues and come up with novel endpoint development strategies
    • Develop and plan innovative regulatory strategies for label enhancements and life cycle product management.
    • Act as the independent subject matter expert in giving guidance to project teams, departments, and management, while considering companywide implications Provide regulatory input to the business development group in the assessment of new product acquisition and product out-licensing candidates; and
    • Manage post-market surveillance requirements for commercial products by assessing regulatory categorization of adverse events reported during use in the population and prepare/file expedited safety and periodic safety reports to FDA.

    Qualifications

    Qualifications:

    • Master's Degree in a scientific discipline required.  Advanced degree preferred (PhD/PharmD)
    • 15+ years of industry experience, with at least 10 years working in regulatory affairs (regionally and/or globally)
    • Substantial experience in all aspects of regulatory affairs, including Commercial support, CMC and Clinical and a track record of successful submissions and license approvals
    • Regulatory experience with biologics and a successful track record leading major applications (such as BLA/MAA) and securing approval

    Knowledge, Skills and Other Experience

    • Strong strategic skills including the ability to make complex decisions and willingness to defend difficult positions
    • Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance pertaining to drug development and commercialization.
    • Substantial experience in representing the sponsor and interfacing and negotiating with regulatory authorities (e.g. FDA, EMA)
    • Demonstrated leadership ability as well as ability to be a team player and work well within cross-functional teams
    • Unquestionable ethics, professional integrity and the ability to motivate and lead others
    • Excellent oral communication and writing skills,
    • Generates innovative solutions in work situations, trying different and novel ways to address work challenges and opportunities
    • Proven ability to work in a small company environment where there is a need to play a both strategic and very hands on role
    • Travel: Up to 25% of the time, including international travel

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