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 towww.baxter.com/inside-baxter/about/overview/corporate.page Summary:Regulatory Affairs Specialist: 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. The Job:
Compile and submit, in a timely matter, regulatory documents according to regulatory requirements, with regulatory experience on local level, e.g. Swiss medic submissions, eCTD submissions and lifecycle management
Manage all regulatory activities in relation to a specific portfolio of products (product owner)
Respond to regulatory authorities’ questions with strict deadlines
Maintain regulatory files in a format consistent with requirements
Obtain, maintain and update existing regulatory authorizations
Provide regulatory advice to project teams.
Lead or represent Regulatory Affairs in project teams
Review promotional material for compliance with local regulations
Supports CQA for product releases
Qualifications
Bachelor’s degree or country equivalent in pharmacy or related scientific discipline. Higher degree/PhD will be an advantage
Minimum 3-5 years’ experience in Regulatory Affairs or equivalent experience within a pharmaceutical company, CRO, or similar organization
Languages Skills
German Fluent
Very good English and French
Computer Skills:
Word and Excel basic knowledge required
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 people's 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.
