Bausch Health

  • Manager - Regulatory Affairs International Support

    Job Location US-NJ-Bridgewater
    Job ID
    11237
    Pos. Category
    R&D
    Pos. Type
    Full Time
  • Overview

    The Regulatory Affairs Manager – International Support-provides information and regulatory support to International Regulatory teams for Product registrations, product renewals, product launches  for ALL company’s US approved products across all the portfolios. Support also provided across all company’s subsidiaries’ products i.e. Solta, Salix, Valeant Med and others.

    Responsibilities

    • Work with members of the RA International Support team to initiate, provide support and assist in maintaining the International Process for all regional RA colleagues across the Bausch Health regions.
    • Liaise with regulatory counterparts to ensure regional requirements are incorporated and met in support of regional new product registrations/new submissions.
    • Provide requested US approved Labeling information  for the development/maintenance of product labels
    • Coordinate with Regional RA Submissions Manager to ensure timely and accurate submissions to Regulatory  Authorities
    • Act as a regulatory contact with US and ex-US Regulatory Leads  for assigned pharmaceutical Rx products’ and medical devices  documentation requests  
    • Coordinate/Liaise with Bausch Health/Valeant country-specific pharmaceutical Regulatory Affairs personnel for international submissions and registrations
    • Manage interactions with other US team experts across company functions (e.g., Quality, Compliance) during Regulatory Authority inspections

    Key Relationships: Internal R&D, Supply Chain, Quality, Clinical and all functions supporting development projects

    Qualifications

    • Excellent communication skills; both oral and written
    • Demonstrated ability in analytical reasoning and critical thinking skills
    • Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies
    • Knowledge of pharmaceutical brand and medical device industry regulatory affairs discipline throughout the product/dossier management lifecycle, including Development, Labeling, CMC, Quality and Operations
    • Ability to interpret Regulatory Authority policies and guidance and correctly apply them as appropriate in regulatory activities for all products
    • Ability to influence and partner with cross-functional teams in a global pharmaceutical organization

    Experience:

    • Minimum of 5+ 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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