Senior Pharmaceutical Affairs Manager Germany & Austria

<p>BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.</p><p></p><p></p><p><b>General Description:</b></p><ul><li>Local Pharmaceutical Affairs /Regulatory Affairs (Pre-Launch, Launch and Life Cycle Management) Operations DE/AT</li><li>Deputy Information Officer</li></ul><p></p><p><b>Essential Functions of the job: </b></p><ul><li>Acts as deputy  local contact person for competent authorities in DE and AT</li><li>Acts as deputy Information Officer</li><li>Supports in local  internal and external audits as well as regulatory inspections  incl. CAPA</li><li>Creates and reviews GxP  relevant local SOPs and working instructions within the RA area, supports other functions (e.g. PV, Medical) in relation to creation and review of GxP relevant SOPs</li><li>Reviews and approves promotional and non-promotional material</li><li>Supports in  the maintenance of local quality manual</li><li>Maintains and develops local GxP training oversight for DE/AT staff and develops specific GxP trainings e.g. for sales representatives</li><li>Supports  in product recalls/mock recalls</li><li>Processes product complaints</li><li>Performs all local activities in relation to EU FMD/ACS Pharma Protect</li><li>Contributes to EU regulatory activities and enquiries such as  HA requests, RA intelligence, etc</li><li>Oversees E2E labelling process</li><li>Coordinates local activities in relation to  labelling change procedures, provides labelling source documentation and acts of owner of local label change tracking database</li><li>Performs local commercial artwork proofreading and provides commercial artwork request and approval</li><li>Manages publication of SmPC (Fachinfo Service) and other publications ( e.g. Rote Liste)</li><li>Supports BeiGene functions and departments (Market Access, Customer Engagement, Medical) in relation to GxP relevant enquiries and document requests </li><li>Supports other departments as CE, Medical and Market Access with GxP expertise and activities in selected projects</li></ul><p></p><p><b>Qualifications: </b>  </p><ul><li>University degree in life sciences/pharmacy</li><li> 7+ years  experience within the GxP/Regulatory field, preferably in affiliate settings</li><li>Fluent German &amp; English</li><li>Computer Skills:<b>  </b> M/S Office, Veeva Vault, SAP</li></ul><p></p><p><b>Travel:</b>  approx. 10%</p><p></p><p></p><p></p><p></p><p></p><p><u><span>BeiGene Global Competencies</span></u></p><p>When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.</p><ul><li>Fosters Teamwork</li><li>Provides and Solicits Honest and Actionable Feedback</li><li>Self-Awareness</li><li>Acts Inclusively</li><li>Demonstrates Initiative</li><li>Entrepreneurial Mindset</li><li>Continuous Learning</li><li>Embraces Change</li><li>Results-Oriented</li><li>Analytical Thinking/Data Analysis</li><li>Financial Excellence</li><li>Communicates with Clarity</li></ul><p></p><p></p><p>We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.</p><p></p><p></p>