Senior Manager (m/f/d) CMC Regulatory Affairs

<p></p> <p> </p> <h2><b>Passion for Innovation. Compassion for Patients. </b></h2> <p> </p> <p>With over 120 years of experience and approximately 19,000 employees in more than 30 countries/regions, 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.</p> <p>In Oncology, we are driving innovation in solid tumours and blood cancers, founded on breakthrough science from our own labs in Japan. We aspire to create better tomorrows for people living with cancer and their loved ones.</p> <p>Our European headquarters are in Munich, Germany, and we have affiliates in 15 European countries and Canada.</p> <p> </p> <p><b> </b></p> <p><b> </b></p> <p><span>We are seeking a highly qualified candidate to fill the position:</span></p> <p> </p> <h2><span>Senior Manager (m/f/d) CMC Regulatory Affairs</span></h2> <p> </p> <h2><span>The function of EU Regulatory Affairs CMC:</span></h2> <p><span>Within Daiichi Sankyo`s Technology Unit, the role of the EU Regulatory Affairs CMC function is to lead the preparation and maintenance of dossiers of Daiichi Sankyo’s development and commercial products, and to submit to EU and international health authorities. To ensure high quality standards and health authority expectations are met, we are both closely interacting with research and manufacturing functions within Daiichi Sankyo and aiming to maintain a trustful relationship with health authorities, striving to ensure on-time approval of our drugs and securing patient supply.</span></p> <h2><span> </span><br/><span>The Position:</span></h2> <p><span>The Senior Manager Regulatory Affairs CMC will provide European regulatory CMC guidance and strategy for assigned products and will represent EU Regulatory Affairs CMC in internal and external interactions (e.g. global and local project teams, working teams, authorities’ communication, CMOs).</span></p> <p><span>A key focus area of the position is the preparation of regulatory CMC documentation for small molecule products during commercial stage, in a manner that is scientifically sound, commercially viable and in accordance with current regulatory CMC standards. </span></p> <p><span>Further, it is the goal of the role to translate latest EU and international regulatory CMC requirements into state of the art, high-quality regulatory CMC documentation, develop EU and international regulatory submission strategies, author dossiers, and technical documents.</span></p> <p> </p> <h2><span>Roles and Responsibilities:</span></h2> <ul> <li><span>Change control assessment including variation classification for EU/EU territory and provision of submission requirements</span></li> <li><span>Authoring of CTD sections (M2.3 and M3) for EU and EU territory, incl. liaising with internal and external stakeholders</span></li> <li><span>Represent EU RACMC function in global internal and external teams and provide RA CMC guidance and strategy to project teams           </span></li> <li><span>Empowered decision maker for regulatory strategy and submission content</span></li> <li><span>Develop holistic regulatory submission strategies for life-cycle management considering prioritization of activities, identification of risks and implementation of risk mitigations                      </span></li> <li><span>Define strategy and respond to Health Authorities queries                       </span></li> <li><span>Keep current with, review and interpret regulatory and scientific regulations, directives, guidelines and initiatives, and communicate important changes and trends with the relevant stakeholders                                                                      </span></li> <li><span>Participate or lead assigned non-project tasks and process improvements          </span></li> <li><span>Ensure maintenance of regulatory compliance      </span></li> </ul> <p> </p> <h2><span>Personal Skills and Professional Experience:</span></h2> <ul> <li><span>Master degree in Life Science or Pharmacy, PhD preferred; Master Degree in Regulatory Affairs is a plus</span></li> <li><span>Minimum of 5 years of experience in the pharmaceutical industry</span></li> <li><span>Minimum of 3 years of experience in global regulatory affairs CMC with proven track record in managing RACMC related life-cycle management activities for EU/EU-territory for small molecules products</span></li> <li><span>Strong RACMC knowledge for both drug substance and drug product</span></li> <li><span>Proven ability to plan, coordinate and lead activities simultaneously on multiple projects</span></li> <li><span>Excellent personal and intercultural skills paired with the ability to work cross functionally in a multinational organi