Bausch Health

  • Manager/ Sr. Manager, Regulatory Affairs

    Job Location US-NY-Rochester
    Job ID
    10527
    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.

     

    Primarily focused on US Regulatory Affairs activities with additional support of global activities as well.

     

    This position will supervise direct reports. 

    Responsibilities

    • Prepare US (510k), PMA, IDE) submissions and technical files
    • Review  and approve  labeling and promotional  materials
    • Develop and recommend regulatory strategies
    • Assist in the review of 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, Pharm O, 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.
    • Minimum 10 years relevant regulatory exeperience.

    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.

     

     

    Valeant Pharmaceuticals International, Inc. is committed to leveraging the talent of a diverse workforce to create great opportunities for our business and our people. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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