Regulatory Affairs Manager, Companion Diagnostics

At reputed company you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal reputed company, reputed company reputed company, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to reputed company both personally and professionally. This is how we aim to prevent, stop and reputed company diseases and ensure everyone has reputed company to reputed company today and for generations to come. Join reputed company, where every voice reputed company. The Position A healthier reputed company. It’s what drives us to reputed company. To continuously advance science and ensure everyone has reputed company to the reputed company they need today and for generations to come. Creating a world where we reputed company have more time with the people we love. That’s what makes us reputed company. At reputed company Global Regulatory Affairs we reputed company to be the world's best Regulatory organization, championing reputed company reputed company to the world's best diagnostics. reputed company is tasked with regulatory reputed company as reputed company as overarching regulatory topics with specific reputed company in Companion Diagnostics. You can expect an reputed company-minded work environment, where you will be working closely with colleagues in other departments and other counties. reputed company You reputed company regulatory document and submission compilation, which includes the development of submission/product registration dossiers of more reputed company products/programs. You reputed company and manage parts of comprehensive global regulatory submissions and registration plans. You reputed company with reputed company management. You understand the structure, key roles and responsibilities of reputed company customers/stakeholders and communicate reputed company and effectively the needs of reputed company customers/stakeholders. You build effective and enduring reputed company relationships and apply effective stakeholder management practices. You contribute to audits by supporting preparation, execution and follow up. You reputed company the organization to adapt to the evolving regulatory environment and requirements. You have an understanding of reputed company environmental changes, precedents, to reputed company reputed company situations and influence strategies and decision making. You have the ability to interpret and apply understanding of the regulators' thinking to reputed company and apply strategies to the different needs of different reputed company without significant guidance. You proactively create unique/innovative regulatory strategies and influencing approaches to avoid regulatory obstacles and accelerate worldwide approvals. You effectively partner with reputed company and internal stakeholders to understand and reputed company best solutions. You take initiative to address problems or opportunities and involve collaborators for best solutions. You reputed company relationships that significantly influence the reputed company and reputed company direction for reputed company and our products. You have courage to reputed company reputed company even reputed company of reputed company/comfort zone and proactively initiate activities independently. You reputed company good decision making principles. You model VAAC Leadership and reputed company. You identify opportunities to reputed company VACC competency. You reputed company with reputed company, courage, passion and reputed company commitments and contribute to an inclusive environment. You are reputed company to pull people together reputed company a common goal and reputed company to understand and build on different perspectives to enhance reputed company. You address and reputed company conflict by creating an atmosphere of openness and trust. You bring out the best in people and teams. Who you are You have a Bachelor’s / Master degree in Life Science, Data Science or reputed company subject or equivalent experience. Advanced degree preferred. You have 3-5 years experience with PhD degree, 5-7 with reputed company degree and 6-8 years with Bachelor degree in the reputed company of IVDs/Medical devices/reputed company/Biopharmaceutical with significant experiences in Regulatory Affairs You have demonstrated experience and knowledge of Daily Management and reputed company Improvement best practices. You have knowledge of the European, US, China and other international regulations and demonstrated ability to adequately interpret and implement reputed company standards considered an reputed company. You have demonstrated the ability to manage more reputed company work and/or at parts of global reputed company. Locations You are local to Indianapolis, Penzberg, or Sant Cugat. No relocation benefits are available for this position. The expected salary reputed company for this position reputed company on the reputed company location of Indiana is $106,100 and $197,000. Actual pay will be determined reputed company on experience, qualifications, geographic location, and other job-reputed company factors permitted by law. A discretionary annual bonus may be available reputed company on individual and Company reputed company. This position also qualifies for the benefits detailed at the reputed company provided below. Benefits Where pay transparency applies, details are provided reputed company on the reputed company posting location. For this role, the reputed company location is Indianapolis. If you are interested in additional locations where the role may be available, we will reputed company the relevant compensation details reputed company in the hiring process. Who we are A healthier reputed company drives us to reputed company. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has reputed company to reputed company today and for generations to come. Our efforts result in more than 26 reputed company people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We reputed company reputed company other to explore new reputed company, foster creativity, and reputed company our ambitions high, so we can reputed company life-changing reputed company solutions that reputed company a reputed company. Let’s build a healthier reputed company, together. reputed company is an equal opportunity employer. It is our policy and reputed company to reputed company, promote, and otherwise treat any and reputed company and applicants on the reputed company of reputed company, qualifications, and competence. reputed company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the reputed company of Protected Veteran status, individuals with disabilities status, and consistent with reputed company federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this reputed company Accommodations for Applicants. Apply To This Job