Valeant Pharmaceuticals

  • Senior Regulatory Affairs Specialist

    Location US-WA-Bothell
    Job ID
    10181
    Category
    Quality
    Pos. Type
    Full Time
  • Overview

    Valeant Pharmaceuticals International, Inc. is a diverse pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization’s potential and what we hope it will become.

     

    This senior professional provides direct support to our North America operations for their globally distributed products.  They work closely with site Engineering and Operations, NA Change Oversight Committees and regional peers to ensure the effective execution and management of changes.

     

    Work Environment:
    Most work will be performed in an office environment. The noise level in the work environment is usually low to moderate.

     

    Safety:
    Solta Medical is committed to the health and safety of our employees. We expect that all employees will perform their responsibilities while maintaining a safe, cooperative, and productive work environment, thus ensuring the health and safety of themselves and others.

    Responsibilities

    • Acts as primary interface between Solta and global regulatory teams
    • Supports requests for Solta information and documentation in support of regulatory submissions
    • Provides input to and supports maintenance of product technical files
    • Evaluates product changes for regulatory impact, documents results, and generates Notified Body Notices of Changes as applicable
    • Provides regulatory expertise to the Product Development and Operations teams, including labeling requirements and submission approval lead times
    • Identifies and communicates new and revised regulatory requirements to the organization, and performs/coordinates impact assessment activities
    • Maintains global Solta product regulatory approval status
    • Facilitates Global Regulatory Assessments through engagement with our international regulatory professionals and international change committees.
    • Primary contact/driver for Solta changes to OUS regulatory.  Support site change implementation process to drive changes that affect ex-US markets.
    • Serves as the focal point for change requests of the various regions, along with requests for information supporting global product registrations.
    • Develops and maintains the underlying processes for this function including performance measures. Based upon system feedback, drives continual improvement in associated QPIs.
    • Helps solidify and strengthen the Global Change Management support network and process through proactive engagement with international peers and key stakeholders.
    • Provides training as required to both international and domestic groups in support of the overall process.

    Qualifications

    • This position requires a minimum of an undergraduate degree, preferable in a science related field.
    • RAPs training preferred but not required.
    • Requires 5-7 years of experience in the development, distribution and life-cycle management of medical device and pharmaceutical products.
    • Possess a keen understanding of Change Management / Life Cycle Management of medical device and pharmaceutical products along with the impact of such changes on global product registrations.
    • Demonstrated ability to work effectively in a self-directed, decentralized team environment of high accountability and complexity.
    • Maintain and manage a complex portfolio of product and process changes.  Develop, strengthen and continually improve supporting processes.
    • Must possess knowledge of current drug and device regulations and regulatory agency organizations.
    • Must possess good interpersonal abilities to work with peers and clients across the organization.
    • Must possess excellent time management and organizational skills to maintain and manage a complex portfolio of changes and process demands.
    • Language and Verbal Skills: Ability to read, analyze, and interpret domestic and international regulatory requirements, engineering drawings and specifications, professional journals, and technical procedures. Ability to write reports and business correspondence in English. Ability to effectively present information and respond to questions from groups of peers, managers, and internal customers. Ability to clearly and concisely convey project accomplishments, obstacles, issues, and project status.
    • Math Skills: Ability to work with mathematical concepts such as probability and statistical inference.  Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
    • Analytical and Reading Skills: Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret a variety of technical documentation.  Ability to read technical and clinical literature and documents and extract important concepts.
    • Physical Requirements: May be required to perform lifting tasks of up to 30 pounds for short durations. Duties of this job may involve sitting for extended periods of time. Duties also involve daily keyboard data entry.

    Be Aware of Recruiting Fraud

    Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

     

    To learn more please read Valeant’s Job Offer Fraud Statement.

     

     

    Valeant Pharmaceuticals International, Inc. is committed to leveraging the talent of a diverse workforce to create great opportunities for our business and our people. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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