Regulatory Affairs Specialist
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
regAs Regulatory Specialist, you will be responsible for the implementation of regulatory strategies, obtain and maintain marketing authorizations for product(s) and communication of general regulatory requirements in support of licensing of Baxter's products.
More specifically, you will:
• Compile and submit in a timely manner, regulatory documents according to regulatory requirements.
• Prepare review and approve labeling and SOP's. Assist lower level team members on complex issues.
• Provide regulatory advice to project teams.
• Provide guidance and coaching for areas of responsibility to lower level team members.
• Respond to regulatory authorities questions with strict deadlines.
• Maintain regulatory files in a format consistent with requirements.
• Develop and initiate complex regulatory project plans.
• Manage regulatory activities relating to specific portfolio of products/projects (product owner).
• Maintain and update existing regulatory authorizations.
• Lead or represent Regulatory Affairs in project teams.
• May review promotional material for compliance with local regulations.
• Use of critical systems such as BPLM, BaxEdge, Trackwise, ...
QualificationsWho You are:
- Education: Bachelor's degree or country equivalent in pharmacy or related scientific discipline. Higher degree/PhD will be an advantage.
- Experience: a minimum of 5 years industrial experience in Regulatory Affairs
- Excellent spoken and written English required
- Computer skills: knowledge in MS Office (Word, Excel, Powerpoint), Outlook and Sharepoint required
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.
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