• Associate Regulatory Affairs Director

    Job Locations US-PA-Exton
    Posted Date 3 months ago(7/25/2018 1:11 PM)
    Job ID
    2018-1086
    # of Openings
    1
    Category
    Development
  • Overview

    This role is an opportunity for a motivated, highly collaborative, and organized individual to impact the long-term value of Idera’s portfolio through efficient delivery of strategically-guided regulatory submissions. This role will also work closely with the cross-functional study/project team in contributing to the development of regulatory and overall product development strategies.

    Responsibilities

    50%
    Regulatory Strategy

    ·         Contribute to development of regulatory strategies for assigned projects that align with overall product strategy and will result in the on-time submission and approval of new products, indications, and variations.

    ·         Ensure that agreed strategy is appropriately reflected in IND, NDA, sNDA, and other required US and ex-US regulatory filings (e.g., CTA, MAA) and activities.

    ·         Develop and maintain highly collaborative working relationships with relevant regulatory authorities.
    50%
    Regulatory Operations

    ·         Ensure compliant and quality implementation of regulatory activities in accordance with agreed strategy and with compliance requirements.

    ·         Plan and coordinate all aspects of regulatory submissions necessary to support global clinical trials and product registrations.

    ·         Ensure high quality and timely regulatory submissions and interactions.

    ·         Maintain current knowledge of FDA regulations and guidance regarding INDs, NDAs and electronic submission requirements, as well as familiarity with analogous EMA regulations and guidance.

    ·         Identify and implement opportunities to improve internal regulatory operations processes.

    Qualifications

    Key Attributes

    • Highly-motivated, tenacious, and personally accountable self-starter who works with a sense of urgency.
    • Highly organized and able to prioritize multiple activities
    • Strong project management skills
    • Highly collaborative and able to successfully and constructively influence others
    • Committed to quality
    • Excellent written and oral communication, presentation and negotiation skills.
    • Thorough knowledge of US FDA regulations and guidance regarding product development (IND), NDA/CTD preparation and submission.
    • Possess strong interpersonal skills and the ability to work collaboratively.
    • Computer literate (e.g., MS Word, MS PowerPoint, MS Excel).

    Education & Experience Requirements

    • Bachelor’s degree, advanced degree in a scientific area preferred.
    • Significant experience in the pharmaceutical industry with approx. 7 or more years in regulatory affairs; recent experience in oncology-related filings and regulatory interactions highly desirable.
    • Meaningful experience in leading or managing successful regulatory initiatives/ projects.
    • Experience in leading and managing complex projects within specific timeframes
    • Experience in generating, editing, reviewing and submission of INDs, CTAs, DSURs, safety reporting, MAAs, BLAs, etc.
    • Proven track record of success in negotiating with regulatory authorities and in representing regulatory interests to internal and external stakeholders.  

    Other Job Requirements

    • Role may include up to 25% travel, primarily domestically

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