Associate Regulatory Affairs - EU Regulatory Procedural Management (m/f/x)

h2 { color: #002060!important; font-family: Arial!important; font-size: 20.0px!important; font-weight: 700!important; } li{ padding-bottom: 0.75rem!important; } h2:not(:first-child) { margin-top: 2rem!important; } div#tor__fextJobDescFooter_content h2{ margin-top: 2rem!important; } h2 { margin-bottom: 1.25rem!important; } <p></p> <p> </p> <h2>Passion for Innovation. Compassion for Patients. </h2> <p> </p> <p>With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.</p> <p>In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.</p> <p>Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.</p> <p> </p> <p> </p> <p>We are seeking highly qualified candidates to fill the position:</p> <p> </p> <h2>Associate Regulatory Affairs - EU Regulatory Procedural Management  (m/f/x)</h2> <p> </p> <h2>The Position:</h2> <p>Provide support for EU Regulatory Procedural Management for assigned projects including all pre- and post-authorization activities ensuring a smooth run of regulatory procedures as well as regulatory compliance.<br/> Act as a representative at project teams assigned, working with EU regulatory strategy leads, with affiliates, license partners and others to support procedural delivery of the projects.</p> <p> </p> <h2>Roles &amp; Responsibilities:</h2> <ul> <li>Support assigned regulatory submissions during development and life cycle management, in alignment with regulatory strategists, for European and other assigned non-EU authorities</li> <li>Serve as a link between regulatory strategists, product support and other disciplines in RA (e.g. RA-CMC, Labelling, Regulatory Operations)</li> <li>As assigned, represent EU regulatory procedural management in global regulatory and development teams and provide EU regulatory procedural guidance and operational strategy for assigned projects</li> <li>As assigned by manager, act as the regulatory contact person for authorities pertinent to procedural matters</li> <li>Support internal communications on regulatory status for the assigned assets</li> <li>Ensure consistency across projects and global alignment/synergies</li> <li>Participate in assigned non-project tasks designed to enhance the operations and processes of Regulatory Affairs</li> <li>Keep current with, review and interpret regulatory and scientific regulations, directives, guidelines and initiatives</li> </ul> <p> </p> <h2>Education &amp; Professional Experience:</h2> <ul> <li>University degree in Pharmacy, Life Sciences, Natural Sciences or Medical Science, Master preferred; Master degree in Regulatory Affairs is a plus</li> <li>Minimum of 1-2 years of experience in Regulatory Affairs; experience with EMA and CAPs is a plus</li> <li>Experience of working in a global environment in interdisciplinary teams</li> <li>Proven ability to plan, coordinate and lead activities simultaneously on multiple projects</li> <li>Excellent personal and intercultural skills paired with the ability to work cross functionally in a multinational organization</li> <li>Ability to develop and maintain good relationships, challenge views, present and argue cases in a professional and respectful manner</li> <li>Solution and detail-oriented; well organized and self-motivated</li> <li>Strong working knowledge of Microsoft Office</li> <li>Excellent written and oral communication skills in English, second EU language preferred</li> </ul> <p> </p> <h2>Why work with us?</h2> <p><br/> </p> <p>Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients’ lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.</p> <p>For more information: www.daiichi-sankyo.eu</p>