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Manager Regulatory Affairs

Req #: 170009ON_en
Location: Braine-l'Alleud, BE
Job Category: Regulatory Affairs
Date Posted: 11/23/2017 9:30:11 AM
Baxter International
Our employees around the world are connected by an enduring commitment to save and sustain lives. This higher purpose binds us as a company in doing work that matters.
Do you want to know why it is so wonderful to work for Baxter? Go to https://www.youtube.com/watch?v=OY89yj_zSIo

The Job

You will be responsible and accountable for all operational aspects of regulatory submissions providing planning and technical support for Baxter’s products for one or more business units/countries.

More specifically, you will:

  • Initiate, manage and maintain operational activities in support of new and existing marketing authorizations.
  • Plan and manage complex projects and prioritize workload.
  • Monitor, evaluate and interpret all applicable requirements, assure compliance with Baxter and external standards.
  • Maintain appropriate communication within the RA function, SBU marketing and other functions primarily at the project team level.
  • Communicate proactively and report to regulatory authorities.
  • Evaluate technical and scientific information, identify deficiencies, implement and execute strategies to remediate risks.
  • Assess impact of new regulations and provide feedback.
  • Set team, group or service objectives to assure they align with the regulatory strategy.
  • Provide technical and strategic input for regulatory decisions.
  • May manage budget at country level.
  • Provide direct supervision of individuals including mentoring, performance management and staffing decisions.
  • Use of critical systems such as BPLM, BaxEdge, Trackwise,…
Who you are
  • Master's degree or country in related scientific discipline. Higher degree/PhD will be an advantage.
  • At least 7 years of experience in Regulatory Affairs
  • Solid Experience in People/ Project management
  • 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.

What we offer

It is a challenging opportunity for you and also a chance to work in a diverse team with a great mix of people. Joining Baxter means joining a team that you can truly learn from!
We encourage our employees to develop their skills to meet the demands of an ever-changing work environment, providing them with opportunities to achieve personal and professional goals that will make them valued contributors throughout their careers. If you have an interest in this great opportunity and think you can make a difference then this could well be the role for you.
If you want to learn more about career opportunities go to http://www.baxter.com/careers.page

Who we are

Baxter touches millions of lives every day. Our products and services are essential building blocks of healthcare. You’ll find Baxter’s products and therapies on nearly every floor, in almost every hospital worldwide. You’ll find us in clinics and in the home. Patients and providers rely on Baxter for lifesaving renal and medical products.
Our mission to save and sustain lives inspires our work and our commitment to expanding access to care, providing cost-effective healthcare solutions, delivering quality products and advancing innovations for the world.
Our 50,000 employees serve patients and clinicians in more than 100 countries and are dedicated to ensuring Baxter is there when patients need care.
Our inclusive culture and a diverse workforce drives innovation, creates trusted partnerships with customers, suppliers, and community partners, and contributes to the success and sustainability of our business.
Every day at Baxter is a chance to save and sustain lives

Equal Opportunity Employer Discrimination: Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

IMPORTANT NOTICE TO AGENCIES:
Baxter does not accept referrals from recruitment agencies regarding the jobs posted on this site unless formally instructed by Baxter. Recruitment agencies are required to contact Baxter’s Human Resources department to obtain prior written approval before referring any candidates to Baxter. Obtaining the prior written approval is a prerequisite to any agreement between the recruitment agency and Baxter. In the absence of such written approval or Baxter purchase order, any actions undertaken by the recruitment agency shall be deemed to have been performed without the consent of Baxter. Baxter shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by recruitment agencies as regards the vacancies posted on this site.


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