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Global Regulatory Affairs Specialist

Req # JR - 023468 Location Guyancourt, Île-de-France Region, France Alternate Location : IT/ROM - Italy Rome Job Category Regulatory Affairs Date posted 06/22/2020

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Responsible for defining regulatory strategies and submissions for drugs and medical devices in support of new and existing marketing authorizations for Acute Therapies business unit /countries.

Essential Duties and Responsibilities

  • Develop and execute regulatory plans for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations
  • Represent or lead the RA function on assigned cross-functional project teams
  • Monitor applicable regulatory requirements; assure compliance with Baxter and external standards
  • Establish appropriate communication within RA and other functions primarily at project level
  • Perform gap analysis and propose solutions
  • Develop and document sound regulatory decisions and justifications
  • Ensure project teams and business objectives and deliverables are aligned with regulatory strategy
  • May provide direct supervision of individuals
  • May review promotional material or SOP’s for compliance with local and global regulations


  • Sound basis of Regulatory knowledge
  • Scientific Knowledge (international Medical Device & Drugs regulations and international standards)
  • Ability to manage complex projects and timelines in a matrix team environment
  • Strong oral and written communication and presentation skills
  • Demonstrated interpersonal skills including strong negotiation skills
  • Ability to independently identify compliance risks and escalate when necessary
  • Ability to lead and coach others

Education and/or Experience

  • Bachelor’s degree or country equivalent in related scientific discipline with a minimum of 5 years’ regulatory experience in RA or related field, including managing people or projects.  Higher degree/PhD will be an advantage.
  • Experience in CMC, management of European procedures and/or FDA for new registrations as variations/renewals is strongly recommended

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 and let us know the nature of your request along with your contact information.

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