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Sr. Specialist, Global Regulatory Affairs

Req # JR - 039844 Location San Ġwann tal-Għargħar, San Ġwann, Malta Job Category Regulatory Affairs Date posted 05/02/2021

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.

Position Summary:

This position is within the Submission Project Management team within Global Regulatory Affairs.

Under limited supervision, responsible for supporting Global Regulatory document planning and submission process for assigned projects/products.

Major Duties and Responsibilities:

Submissions:

  • Responsible for creating and maintaining project information for assigned submissions
  • Understand the technology used to support all aspects of the submission and publishing process
  • Support new processes to move the organization to electronic submissions globally
  • Ensure that teams adhere to the business processes outlined by global initiatives
  • Support the assembly, review and technical approval for regulatory dossiers and documents for assigned products
  • Focused regional support for EU submissions

    Project management:

  • Identify appropriate resources needed to support submission activities
  • Support submission team in planning, scheduling, coordinating and executing regulatory submission development
  • Promote standardization of submission processes within the organization
  • Report submission updates within defined timelines against milestones and define risks which could affect submission timeline
  • Support submission content/format to ensure high quality submissions to Regulatory Authorities.

    Additional Responsibilities:

  • Establish and maintain positive relationships with cross-functional counterparts
  • Ensure the use of appropriate document policies and standards to create “Regulatory Submission Ready” documents
  • Identify, manage, and support Global Regulatory Affairs process improvements
  • Support additional projects as assigned

Requirements/Qualifications:

Education: Bachelor’s degree or country equivalent

Experience/Qualifications:

  • Minimum of 2 years regulatory or equivalent experience, including demonstrated experience in project management and regulatory submissions (drug and device experience would be an advantage)
  • General understanding of US and ex-US Health Authority requirements regarding submission content and format; focused knowledge on EU Regulations would be advantage
  • Strong interpersonal, communication and presentation skills
  • Technical understanding and project management skills
  • Ability to multitask and manage multiple and changing priorities
  • Highly self-motivated individual and self-starter, independent worker
  • Ability to work under pressure and adhere to deadlines
  • Ability to work effectively in multinational/multicultural environment
  • Computer proficiency in Microsoft Office required, including: Word, Excel, PowerPoint, Project, Outlook and Visio. 
  • Experience in electronic document management/publishing systems is desired
  • Fluent command of spoken and written English

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [email protected] and let us know the nature of your request along with your contact information.

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