Baxter Healthcare Work Values

Daily Duties at Baxter Healthcare :

Responsible for all Global Regulatory Affairs activities providing strategic and operational leadership to the development and maintenance of a diverse portfolio of products, including parenteral nutritionals, IV solution therapies, medicinal foods, and novel container closure systems. Accountable for all regulatory submissions globally, ensuring that they meet appropriate standards and content requirements for global and/or regional registrations. Accountable for all regulatory interactions and negotiations with Regulatory Authorities and for establishing regulatory strategies in alignment with overall business goals. Manage a team of twelve Regulatory Affairs Professionals. • Successfully negotiated and obtained marketing authorization in Europe for a first in class parenteral nutritional product for pediatric populations via the Decentralized Procedure (DCP), including: • Obtaining Scientific Advice from the Reference Member State • Submission of a CTA and PIP to support a Phase III clinical trial • Submission of the CTD to support marketing authorization • Responding to Assessment Reports and Consolidated List of Questions from 18 Concerned Member States and • Label Negotiations • Successfully obtained marketing approval for parenteral nutritional therapies for adult patients in Europe via the Mutual Recognition Process (MRP), as well as, in Canada and Latin America. • In collaboration with regional partners, successfully negotiated with Chinese Health Authorities (SFDA) on the approval of novel container closure systems, as well as, clinical trial designs for novel nutritional therapies. Executive regulatory representative and business liaison for the IV Solution and Nutrition Strategic Business Units. • Identify strategic regulatory risks and through scenario and contingency planning develop alternative courses of action • Collaborate with regional partners to assess the potential impact of changing regulatory, medical and marketplace environments on product development and business plans • Collaborate with marketing, R&D, and clinical to ensure successful execution of business strategies, product launches, product labeling and messaging • Provide strategic and operational input on clinical trial development for Phase I through IV • Collaborate with pharmaceutical development and manufacturing to ensure the development of robust manufacturing processes and test methods that meet global manufacturing requirements and regulatory standards. Assess the regulatory reporting and data requirements to support manufacturing changes (CBE-0, CBE-30 and PAS) • Collaborate with business development for due diligence activities and participate in the strategic development of brand life-cycle management plans (2 global due diligence projects)

What they like about Baxter Healthcare :

Working in an organization that is technologically advanced, creative, and innovative is critical in your assessment of hiring companies. Less important to you are stability of the organization, the length of time an organization has been in business, and the business' plans for the future. You prefer a fast-moving company that will take risks to achieve its goals and objectives. The length of time the company has been in business is irrelevant. Maintaining status quo is unnecessary. You thrive on change, uncertainty and the upside of potential business risks, especially those associated with innovation. Stability for the long haul is not nearly as important as is working in an atmosphere that is charged with a sense of urgency and constant change.

Tags

regulatory affairs, pharmaceutical, biotechnology, clinical , manufacturing

Skills

These are some of the questions we asked our climbers about their experiences with Baxter Healthcare :