Join the professional team of the 120-year-old Gedeon Richter Plc., a leading pharmaceutical company in Hungary and the region! New molecules, new medicines, new processes, and new technologies - Richter invites innovative minds to exploit their full capacities. With our research and development base with 1000 professionals, we have one of the most significant innovation centres not only in Hungary but in the entire Central and Eastern European region. In addition to applied scientific work, we also support individual research fields and topics, as well as publishing activities and participation in scientific life. Gedeon Richter is looking for a committed and experienced professional for the position Biotech CMC RA Manager <div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:14.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px">Responsibilities</H2> </div><div><ul style="margin-bottom:11.0px"> <li>You will be accountable for authoring, review and delivery of the CMC dossiers with high quality standards and within portfolio defined timelines</li> <li>Develop/implement effective CMC regulatory strategies for clinical trial material and all marketing authorization procedure submissions worldwide</li> <li>You will be accountable for CMC-related Life-Cycle Management and post-approval activities (variations) of marketed products and for delivery of submission packages with high quality standards and within portfolio defined timelines</li> <li>Provide guidance for regulatory CMC aspects of finished products and development products in multiple projects; you identify regulatory drawbacks</li> <li>Develop, author and/or review documents to ensure that all submissions conform to health authority guidelines/expectations</li> <li>Drive internal and external (Health Authorities) regulatory CMC discussions and interactions to facilitate review and approval of submissions for all CMC aspects of the dossier</li> <li>Provide interpretation of regulatory guidance documents, regulations and directives – advise Manufacturing, Quality, Process/Analytical Development and Comparability units regarding their applicability and impact on internal programs</li> <li>Providing high quality, proactive, strategic, effective and efficient healthcare compliance advice. Manage the development and discussion of the company strategy if needed</li> <li>Solve complex and high-responsibility tasks independently</li> <li>Make independent professional decisions in case of high complexity tasks</li> <li>Identify and proactively mitigate roadblocks</li> <li>Identify, solve and communicate regulatory CMC risk and key mitigations</li> <li>Participate as an (pro-)active member of multi-disciplinary teams, ensuring appropriate and effective communication to define content for regulatory submissions</li> </ul></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:14.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px">Your profile</H2> </div><div><ul style="margin-bottom:11.0px"> <li>At least a MSc in life science or relevant scientific field (e.g. Biochemistry, Biology, Chemistry, Chemical Engineering, Pharmaceutics with focus on protein chemistry)</li> <li>3+ years of experience in Industry or at Health Authority in regulatory CMC of biotechnological products (Registration, Post-approval procedures, Clinical trial applications, Scientific Advices)</li> <li>Good understanding of current regulations in EU, USA and ROW for (investigational) medicinal products</li> <li>Good understanding of current GMP for biotechnological medicinal products</li> <li>Robust understanding of biologics / recombinant molecules and biosimilars (synthetic peptides is a plus)</li> <li>Experience with document management systems and CTD publishing software. Knowledge of industry change control procedures/systems is a plus.</li> <li>Positive, open-minded, curious, and eager to learn every day. Growth mindset, a “can-do” attitude</li> <li>Very good written and oral English communication skills</li> </ul></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:14.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px">Other information</H2> </div><div><ul> <li>The position is fixed-term (maternity leave)</li> </ul></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:14.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px">We offer</H2> </div><div><ul> <li>Great opportunity for professional development in an innovation driven department</li> <li>Great reputation at a well established pharmaceutical firm</li> <li>Stability and a trustworthy workplace</li> <li>Work in multidisciplinary teams</li> <li>Training and development opportunities</li> <li>Medical services and life insurance</li> <li>Various sport and health opportunities</li> <li>Excellent work life balance</li> </ul></div></div></div>The Richter community is looking forward to your application.

Biotech CMC RA Manager (Budapest, HU) @ Richter Gedeon Vegyészeti Gyár Nyrt.

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