Director, Regulatory Affairs

  • Location

    United States Virgin Island

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    £180000 - £220000 per annum + Bonus, Shares

  • Contact:

    Carlos Biggemann

  • Contact email:

    Carlos.Biggemann@volt.eu.com

  • Job ref:

    77614-PHARM-CBG_1607617066

  • Published:

    4 months ago

  • Duration:

    permanent

  • Expiry date:

    2021-02-08

  • Start date:

    01/02/2021

  • Consultant:

    #

ESSENTIAL FUNCTIONS
*Partner with health authority project managers and review teams to represent their perspective in the Company.
*Develop regulatory strategy for development and commercial projects.
*Provide regulatory guidance and support to various departments including Clinical Research, Manufacturing, Commercial and Business Development.
*Analyse regulatory history and competitor information to provide regulatory intelligence across relevant therapeutic areas and indications.
*Review promotional and non-promotional materials for marketed products, and lead the Medical-Legal-Regulatory Review process
*Coordinate project regulatory operations services.
*Manages, drafts, and aids in securing internal approval of FDA meeting requests and briefing books.
*Manages labelling documents, including preparing package inserts, as well as aiding in quality control of labelling submissions.
*Responsible for managing the compilation, submission and maintenance of INDs, NDAs, amendments and supplements.
*Support and participate in the Company's due diligence activities in evaluating potential products for acquisition/in-licensing/joint development opportunities.


JOB REQUIREMENTS
Technical Skills/Knowledge
*7+ years of regulatory experience in the pharmaceutical or biotechnology industry, preferably in an in-house capacity.
*Experience in working with development project teams in a regulatory leadership role.
*Experience with FDA regulations and their impact across the entire development cycle including promotion of pharmaceutical products and labelling.
*Experience across multiple therapeutic areas is a plus.
*Ability to provide strategic and operational guidance across all levels of the company and external vendors.