Bausch Health

  • Senior Manager, Regulatory Affairs-CMC, Medical Device

    Location US-SC-Greenville | US-NJ-Bridgewater
    Job ID
    11236
    Category
    R&D
    Pos. Type
    Full Time
  • Overview

    The Global Regulatory Affairs – CMC Medical Devices Senior Manager independently manages all regulatory CMC post-approval aspects of Bausch Health’s medical device products. This includes assessing manufacturing changes for regulatory impact, coordinating development of regulatory strategies for regulatory submissions in support of the manufacturing changes and authoring the necessary post approval submissions including annual reports and memoranda to technical files.   The Senior Manager manages interactions with regulatory authorities on CMC issues.

    Responsibilities

    • Formulate, lead and drive post-approval CMC regulatory strategy for marketed products with input from Product Lead as needed.
    • Provide input into CMC regulatory strategy for development products working closely with the Product Lead.
    • Proactively communicate CMC regulatory strategy, key issues and any other critical topics throughout the life cycle to interdisciplinary project teams and to appropriate management level in Regulatory Affairs, R&D, TechOps and Supply Chain as appropriate in an a timely manner.
    • Lead and drive all post-approval CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products. Make quality regulatory decisions, balancing regulatory compliance risks and business benefits.
    • Identify as early as possible, the required documentation and any content, quality and/or timeline for post-approval submissions. Negotiate the delivery of approved technical source documents in accordance with project timeline.
    • Coordinate with Regulatory Operations to ensure timely and accurate submissions to Regulatory Authorities.
    • Manage interactions with Health Authorities on CMC issues.
    • Provide regulatory support to other Valeant functions during Regulatory Authority inspections.
    • Serve as Regulatory Affairs representative on facility/site Local Change Management Boards.
    • Participate in assigned due diligent business activities.
    • Review and provide input on proposed health authority guidance documents on CMC issues.

    Scope of Position:

    Formulate, lead and drive post-approval CMC regulatory strategy for marketed products. Lead and drive all CMC submission activities (planning, authoring, reviewing, coordination, submission). Lead FDA or other Health Authority interactions on CMC issues.

    Qualifications

    • Knowledge of development and life-cycle management support of medical devices and combination products.
    • Knowledge of current and emerging issues and trends of the medical device regulatory environment.
    • Capability to react quickly to changes in the regulatory environment and make strategic recommendations to minimize risk to the business.
    • Ability to influence external regulatory stakeholders and shape the external regulatory environment.
    • Ability to interpret Regulatory Authority policies and CMC guidance and correctly apply them as appropriate in product development and post-approval activities.
    • Ability to influence and partner with cross-functional teams.
    • Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data.
    • Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks.
    • Self-motivated, detail-oriented and capable of working independently.
    • Demonstrated ability in analytical reasoning and critical thinking skills.
    • 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.

     

    Experience:

    • 8+ years pharmaceutical industry and 6+ relevant regulatory CMC experience with at least 3+ years specific experience in supporting medical devices.
    • CMC submission experience with Class I, II and III medical devices in US and Class IIa & IIb in EU and working knowledge of Technical Files.
    • Bachelor’s degree in science, bio-chemical engineering, pharmacy or other health related field.
    • Advanced degree highly preferred ( MS, Pharm.D, Ph.D. or equivalent)

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