Bausch Health

  • Manager / Sr. Manager, Regulatory Affairs

    Job Location US-NY-Rochester
    Job ID
    10753
    Pos. Category
    R&D
    Pos. Type
    Full Time
  • Overview

    Valeant Pharmaceuticals International, Inc. 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.

     

    Handle all regulatory aspects for assigned Business Unit. Participates on product development teams, including new product, geographic expansion, and maintenance of business. Interacts with Regulatory Authorities.

     

    This position will supervise direct reports. 

    Responsibilities

    • Prepare US (510(k), PMA, IDE) submissions and technical files
    • Review and approve labeling and promotional materials
    • Develop and recommend regulatory strategies
    • Assist in the review and policies and procedures. 
    • Interact with the FDA and other regulatory agencies
    • Provide coaching to regulatory specialists
    • Other job responsibilities as needed.
    • Key Relationships: 
      • Internal stakeholders
      • Internal cross-functional teams
      • External regulatory authorities.

    Qualifications

    • Bachelors degree in science or health related field required. Advance degree preferred (PhD, MD, MS, PharmD, or equivalent)
    • Must possess at least a mastery level of performance in the majority of the following core competencies:  influence key stake holders, business acumen, project management, relationship building, regulatory expertise.
    • 7-10 years relevant regulatory experience.

    Be Aware of Recruiting Fraud

    Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

     

    To learn more please read Valeant’s Job Offer Fraud Statement.

     

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