Bausch Health

  • Senior Regulatory Affairs Specialist, Generics

    Job Location US-NJ-Bridgewater
    Job ID
    11238
    Pos. Category
    R&D
    Pos. Type
    Full Time
  • Overview

    The Regulatory Affairs Senior Specialist executes on the pharmaceutical regulatory strategies for assigned generic products.  Supports the Regulatory Affairs Senior Manager for Generics submission to maintain submission timelines and assists in preparing new and maintenance of business generic submissions.

    Responsibilities

    • Provide support for the execution of the pharmaceutical regulatory strategy for assigned generic products
    • Support regulatory aspects of product development team for agency filing
    • Work with the Pharmaceutical Regulatory Senior Manager to make certain all product documentation is developed in accordance with regulatory requirements; serves as designee as needed.
    • Assist in preparing documentation required for filing of new ANDAs, post approval supplements and Annual Reports as necessary.
    • Support the preparation of documentation and materials required for meetings with Regulatory Authorities for assigned generic products
    • Liaise with country-specific regulatory affairs personnel for international submissions and registrations, as needed
    • Occasional travel may be required

    Key Relationships:

    • Demonstrated ability in analytical reasoning and critical thinking skills
    • Strong capability to contribute to a team environment
    • Strong business acumen and ability to see the business drivers outside of Regulatory Affairs
    • Excellent communication skills; both oral and written
    • Strong interpersonal skills with the ability to influence others in a positive and effective manner
    • Demonstrated ability to contribute to a continuous learning and process improvement environment
    • Capacity to react quickly and decisively in unexpected situations
    • Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies
    • Focused ability to influence operational excellence and performance metrics
    • Risk adverse where needed with the ability to identify potential solutions to complex problems

    Qualifications

    • Knowledge of pharmaceutical industry regulatory affairs discipline throughout the product lifecycle, including Development, Promotion and Advertising, Labeling, CMC, Commercialization, and Operations
    • Knowledge of domestic regulations laws, regulations, and guidance
    • Knowledge of clinical development, including responsibilities for successful management of development milestones and market authorization
    • Ability to partner within regulatory and with cross-functional teams in a pharmaceutical organization
    • Ability to understand scientific information and assess whether technical arguments are articulated clearly
    • Ability to assess project risks and where appropriate, escalate accordingly

    Experience:

    • 3-4 years relevant pharmaceutical industry and regulatory experience
    • Generics experience preferred
    • Bachelor’s degree in science or health related field
    • Advanced degree preferred (PhD, MD, MS, PharmD, or equivalent)

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