Regulatory Affairs Manager

This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare. Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission. SUMMARY You will be responsible and accountable for all local operational aspects of regulatory submissions providing planning and technical support for Baxter’s Pharmaceutical products in Europe. Instrumental in the design and definition of the Regulatory strategy for the products. You will manage regulatory activities relating to the Pharmaceutical-specific portfolio of products/projects. Essential Duties and Responsibilities: • Develop and execute regulatory plans aligned with business strategy for complex projects including new products and maintenance of licenses/authorizations for existing marketed products • Identify & prioritize key areas of risk and develop & implement appropriate mitigation plans • Monitor applicable regulatory requirements; assure compliance with Baxter and external standards • Perform gap analysis on regulatory documentation and propose solutions. Identify areas for improvement • Develop and document sound regulatory decisions and justification • Interact and negotiate with regulatory authorities leading to successful outcomes for original dossiers, variations and other regulatory strategic initiatives • Establish appropriate communication within RA, with local Marketing, and with other functions primarily at a project level and favor proactive communication • Ensure regulatory strategy and deliverables are aligned with project teams and business objectives • Lead regulatory activities related to assigned portfolio of products, with a strong emphasis on specialty injectable products • May review and approve labeling, and SOPs for compliance with local regulations • Represent or lead the RA function on assigned cross-functional project teams • May represent Baxter interests in industry and working groups • Provide direct supervision of individual(s) Qualifications: • Scientific knowledge with strong problem-solving skills • Ability to work to deadlines and successfully prioritize numerous projects simultaneously • Ability to work effectively in a multinational/multicultural environment • An in-depth understanding and experience of EU regulatory requirements including marketing authorization submissions and maintenance activities on a European level • Ability to manage complex projects and timelines in a matrix team environment • Strong interpersonal, communication and presentation skills • Demonstrated interpersonal skills including strong negotiation skills • Ability to independently identify compliance risks and escalate when necessary • Experience in dealing with regulatory agencies • Ability to lead and coach others Education and/or Experience: – Bachelor’s degree or country equivalent in a scientific discipline – Masters and/or PhD preferred. – Minimum of 5-year regulatory experience in RA or related field, including managing people or projects. – Experience working in a pharmaceutical company with sterile injectable products 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_TTAbaxter.com and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice . 111703 J-18808-Ljbffr