Bausch Health

  • Associate Director, Regulatory Affairs

    Location US-NJ-Bridgewater
    Job ID
    12010
    Category
    R&D
    Pos. Type
    Full Time
  • Overview

    Bausch Health 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.

     

    The Regulatory Associate Director handles regulatory development and post-approval/regulatory compliance for assigned products. Participates on the product development/life-cycle management team to provide regulatory guidance for assigned pharmaceutical Prescription products. Manages relevant regulatory strategy components and interactions with Regulatory Authorities for these products. May perform due diligence efforts on new product opportunities.

    Responsibilities

     

    • Responsible for developing a product regulatory strategy for pharmaceutical products
    • Liaise with regulatory counterparts to ensure regional requirements are incorporated into product strategy development
    • Develop a product regulatory timeline aligned to Bausch Health product development, with key regulatory milestone, and activities for agency filing
    • Coordinate with the Labeling Lead for the development/maintenance of product labels
    • Ensure labeling content and product documentation is developed in accordance with regulatory requirements
    • Participate as a member of the product development team(s) to build awareness of Regulatory Authority requirements and timing for submissions
    • Coordinate with Submissions Manager to ensure timely and accurate submissions to Regulatory Authorities
    • Act as a regulatory contact with Regulatory Authorities for assigned pharmaceutical Rx products
    • Coordinate/Liaise with Bausch Health country-specific pharmaceutical Regulatory Affairs personnel for international submissions and registrations
    • Manage interactions with other Bausch Health functions (e.g., Quality, Compliance) during Regulatory Authority inspections
    • Provide regulatory guidance/input to internal product review boards
    • Manage assigned personnel
    • Occasional travel may be required

     

    Key Relationships: 

    • Demonstrated ability in analytical reasoning and critical thinking skills
    • Strong capability to contribute and lead 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 brand industry regulatory affairs discipline throughout the product/dossier management lifecycle, including Development, Promotion and Advertising, Labeling, CMC, Commercialization, and Operations
    • Knowledge of domestic and international laws, regulations, and guidance that affect Brand products
    • Knowledge of clinical development, including responsibilities for successful management of development milestones, and/or marketing authorization, meeting facilitation, labeling negotiations, and regulatory responses
    • Ability to interpret Regulatory Authority policies and guidance  and correctly apply them as appropriate in product development and labeling 

     

     Experience: 

    • 10+ years relevant pharmaceutical industry and regulatory experience
    • Pharmaceutical Rx experience highly preferred
    • Bachelor’s degree in science or health related field

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