Bausch Health

  • Senior Manager, Regulatory Affairs

    Job Location US-NJ-Bridgewater
    Job ID
    11215
    Pos. Category
    R&D
    Pos. Type
    Full Time
  • Overview

    The Regulatory Senior Manager 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 the business unit’s 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 Regulatory Operations 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 Valeant country-specific pharmaceutical Regulatory Affairs personnel for international submissions and registrations
    • Manage interactions with other functions (e.g., Quality, Compliance) during Regulatory Authority inspections
    • Provide regulatory guidance/input to internal product review boards
    • May 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
    • Demonstrated experience with health authority submissions, i.e, authored, reviewed and managed an original/supplemental application (IND, NDA, BLA, MAA, CTA, NDS, etc.
    • Ability to interpret Regulatory Authority policies and guidance and correctly apply them as appropriate in product development and labeling regulatory activities for Brand products
    • Ability to influence and partner with cross-functional teams in a global pharmaceutical organization
    • Ability to take innovative ideas from proof of concept to promote a successful product regulatory strategy and increase probability of regulatory approval
    • 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

    Experience:

    • 8+ years relevant pharmaceutical industry and regulatory experience
    • Pharmaceutical Rx experience highly preferred
    • Bachelor’s degree in science or health related field
    • Advanced degree preferred (PhD, MD, MS, PharmD, or equivalent)

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