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Regulatory Affairs Manager

Req # JR - 022640 Location Braine-l'Alleud, Wallonia, Belgium Job Category Regulatory Affairs Date posted 06/17/2020

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Summary

Responsible for independently defining global regulatory strategies and authoring eCTD submission content (EU / US) in support of new and existing marketing authorizations for pharmaceutical products for Renal Care drug products.

Essential duties and responsibilities

  • Develop and execute regulatory plans and strategies for complex projects that impact existing drug product marketing authorizations globally.
  • Author and coordinate submission content (eCTD M1-M5) for drug product marketing authorizations and variations / supplements to support dossier maintenance in EU / US.
  • Perform regulatory impact assessments to determine reportability of proposed CMC and labeling changes on EU/US registrations.
  • Develop and maintain drug product labeling content globally.
  • Author submission content and deliverables in support of drug product registrations in the Americas, Asia Pacific, and Eastern Central Europe / Middle East / Africa.
  • Provide RA functional leadership and participation on assigned cross-functional project teams and process improvement workstreams.
  • Develop and document sound regulatory decisions and justifications
  • Identify and prioritize key areas of risk and develop / implement mitigation plans.
  • Establish appropriate, proactive communication within RA, with GBU Marketing, and other functions to ensure business objectives are consistently met. 
  • Communicate with regulatory authorities as required.
  • Monitor, evaluate, and interpret applicable regulatory requirements; assure compliance with Baxter policies / procedures and external standards

Qualifications

  • Bachelor’s degree or country equivalent in related scientific discipline.  Master’s degree/PhD will be an advantage.
  • Minimum of  5 years regulatory experience in RA or related field, including managing people or projects.    
  • Strong oral and written communication skills in English
  • Lean Six Sigma / Green Belt certification will be valued.
  • Direct, demonstrated experience in EU / US submission content authoring and preparing complex variations / supplements;
  • Proven track-record of executing regulatory strategies with positive outcome and on-time approvals.
  • Ability to manage complex projects and timelines in a matrixed team environment;
  • Ability to work effectively in multinational / multicultural environment
  • Strong oral and written communication skills and technical writing skills
  • Sound basis of regulatory knowledge and strategic thinking
  • Demonstrated interpersonal skills, including strong negotiation skills
  • Ability to independently identify risks and escalate when necessary
  • Demonstrated ability to lead and mentor others
  • Scientific knowledge and previous work experience supporting aqueous pharmaceutical injections / solutions considered a plus.

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.

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