Ashland Corporate

  • Regulatory Affairs Professional, Pharmaceutical and Medical Device

    Job Locations US-DE-Wilmington | US-NJ-Bridgewater
    Job Post Information* : 3 weeks ago(10/3/2018 4:29 PM)
    Requisition #
    2018-7345
    # of Openings
    1
  • Overview

    Are you the kind of person that is always thinking, sketching, seeking, and adjusting? Who needs to understand how things work and then figure out how they can work better? Are you a passionate, tenacious, solver who loves to work with others who share your drive? Are you positive, constructive, and ingenious?

     

    Are you always solving?

     

    Then we’d like to meet you and bet you’d like to meet us.

     

    Ashland has an exciting opportunity for a Regulatory Affairs Specialist to join our Ashland pharmaceutical and medical device business at our Bridgewater, NJ and Wilmington, DE locations. This is a very visible, significant role within the Company and the regulatory function. This position will report to Manager of Regulatory Affairs.

    Description

    The responsibilities of the position include, but are not limited to, the following:

    • Develop and update Master Files for pharmaceuticals and medical devices, including periodic amendments
    • Establish and maintain regulatory statements and position papers
    • Submit applications, including renewals, for registration and certification to regulatory agencies such as US FDA
    • Conduct reviews of labeling and marketing collateral for regulatory and claims review
    • Monitor new and changing regulations to interpret requirement and their impacts to Ashland’s products and facilities
    • Participate in trade association meetings and webinars
    • Work together with plant quality and other EHS functions to support customers
    • Some travel may be required to support plants and customers

    Qualifications

    In order to be qualified for this role, you must possess the following:

    • Some knowledge of product regulations, enforcement and industry practice relevant to the pharmaceutical excipient and medical device industries
    • 2 - 5 years of Product Regulatory relevant experience working with regulatory agencies such as US FDA
    • Bachelor or Master Degree, in chemistry, toxicology, biology or other science discipline

    The following skill sets are preferred by the business unit:

    • Professional regulatory certification preferred
    • Fast learner with a flexible style and the ability to adjust to changing business priorities and changing regulatory landscapes
    • Responsive and highly accountable: solution-, results- and action-oriented
    • Excellent verbal / written communication and interpersonal skills
    • Ability to interface with internal and external contacts at all levels
    • Excellent organizational and prioritization skills
    • Ability to work collaboratively with peers
    • Ability to handle multiple tasks / projects simultaneously
    • Self-starter with ability to think and act independently and to make sound recommendations and decisions
    • Demonstrated ability to manage projects across complex organizations
    • Good analytical and problem-solving skills
    • Must be able to work in a multi-cultural environment

     

    TO APPLY FOR THIS POSITION, please select the Apply button. If no Apply button is provided, please visit Ashland's Career Center. Once there, enter job number 2018-7345 in the Keyword Search field to find this posting and apply on-line.

     

    NOTE:  We do not accept resumes from external staffing agencies or independent recruiters for any of our openings unless we have a signed recruiting agreement in place to fill a specific position.

     

    Ashland Global Holdings Inc. (NYSE: ASH) is a premier, global specialty chemicals company serving customers in a wide range of consumer and industrial markets, including adhesives, architectural coatings, automotive, construction, energy, food and beverage, personal care and pharmaceutical. At Ashland, we are approximately 6,500 passionate, tenacious solvers – from renowned scientists and research chemists to talented engineers and plant operators – who thrive on developing practical, innovative and elegant solutions to complex problems for customers in more than 100 countries. Our people are distinguished by their ability to create and apply specialized chemistry in ways that enable customers to amplify the efficacy, refine the usability, add to the allure, ensure the integrity, and improve the profitability of their products and applications. Visit ashland.com to learn more. 

    C-ASH

    Ashland. always solving

     

    We are passionate, tenacious, solvers who thrive on developing practical, innovative and elegant solutions to complex problems in applied chemistry, always pushing the boundaries of what’s possible, and advancing the competitiveness of our customers across diverse industries.

     

    Our people—molecular scientists, chemists, process engineers, logisticians, research scientists, economists, analysts, compliance auditors, salespeople, safety experts and more—are distinguished by their ability to create and apply specialized chemistry in ways that enable customers to amplify the efficacy, refine the usability, add to the allure, ensure the integrity, and improve the profitability of their products and applications.

     

    The Ashland Way

     

    Our vision, mission, way and values are the foundation for what makes Ashland, Ashland. What we aspire to accomplish, how we work every day toward that vision, and the way that we do things are what give substance to the promises we make to each other, customers and investors.

     

    Our vision is to make a better world by providing creative solutions through the application of specialty ingredients and materials.

     

    Our mission is to develop practical, innovative, and elegant solutions to complex problems in applied chemistry, always pushing the boundaries of what’s possible, and advancing the competitiveness of our customers across diverse industries.

     

    Our way is to respect, protect, and advance the people we work with, companies we serve, shareholders who invest in our future, communities we’re a part of, and planet we share.

     

    Ashland is proud to be an Equal Opportunity Employer Minorities/Women/Veterans/Disabled/Gender Identity/Sexual Orientation. 

    Ashland is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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