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    Senior Specialist, Regulatory Affairs - Mississauga, Canada - Baxter

    Baxter
    Baxter Mississauga, Canada

    4 days ago

    Default job background
    Full time
    Description

    This is where you save and sustain lives

    At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

    Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

    Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

    Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

    Your role at Baxter

    This is where your expertise lead to success

    As a Senior Specialist, Regulatory Affairs you will be implementing local regulatory strategies, acquire and maintain marketing authorizations for product(s) and communication of local regulatory requirements in support of licensing of Baxter's products.

    We're a friendly, collaborative group that help each other to constantly push each other to do better.

    We understand that learning and development are important. Whether it's training, striving toward a promotion, or gaining experience with other portfolios or business units, Baxter leaders frequently speak with their teams about how employees are trying to grow and how they can support those efforts. With the ability to chart your own path, the development opportunities are endless.

    What you'll be doing

  • With direction, develop and execute regulatory project plans
  • Identify and elevate key areas of regulatory risk
  • Maintain regulatory files in a format consistent with requirements
  • Maintain awareness of regulatory requirements; identify relevant requirements
  • Participate as an active team member and provide regulatory advice to project teams as required
  • Respond to questions from regulatory authorities within strict timelines
  • Compile and submit, in a timely manner, regulatory documents according to regulatory requirements
  • Maintain and update existing regulatory authorizations
  • Support regulatory activities relating to specific portfolio of products/projects
  • Prepare, review, and approve labeling and review AdProm materials for compliance with local regulations
  • Prepare SOPs to reflect specific local requirements.
  • Represent or lead Regulatory Affairs in small project teams

    • What you'll bring

  • Bachelor's degree or country equivalent in a scientific discipline
  • Minimum of 2 years regulatory or equivalent experience within a pharmaceutical and/or medical device company, CRO, or similar organization
  • Strong project management skills
  • Ability to lead multiple projects and priorities
  • Interpersonal and communication skills along with Negotiation skills
  • Hands on technical expertise (e.g. word processing, spreadsheets, databases, online research)
  • Ability to identify compliance risks and escalate when necessary

    • #LI-BAXGEN

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