Skip to main content

Global Regulatory Affairs Manager

Req # JR - 023468 Location Guyancourt, Île-de-France Region, France Alternate Location : Deerfield, Illinois, United States Job Category Regulatory Affairs Date posted 06/22/2020

Are you looking for a career that matters?

We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.

Learn more about how Baxter is At the Intersection of Saving and Sustaining Lives.

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

Qualifications

  • 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 Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.

Join Our Talent Community

This website is owned and operated by Baxter Healthcare Corporation [One Baxter Parkway, Deerfield, IL 60015-4625] ("Baxter") acting as data controller for itself and on behalf of all of its affiliates and subsidiaries. By clicking on the “Subscribe” button I declare that I have read the Privacy Policy and consent to Baxter processing my personal data for the purposes of joining the Baxter Talent Community: to provide me via email with job offers in the area of my interests and to provide me information about Baxter. I am aware that I have the right to withdraw my consent by clicking the “Unsubscribe” option in the emails I receive from Baxter.

Select InterestsSelect a job category from the list of options. Search for a location and select one from the list of suggestions. Finally, click “Add” to create your job alert.

  • Regulatory Affairs, Guyancourt, Île-de-France Region, FranceRemove

    You have not recently viewed any jobs.

    You have not saved any jobs.