Manager/Senior Manager u2013 Regulatory Affairs CMC

Profile

Who We Are For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more. And the more people we reach, the more our impact can grow. We transform lives through genetic discovery. Our Culture Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard u2013 so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients. BioMarinu2019s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class or best-in-class therapeutics that provide meaningful advances to patients. Come join our team and make a meaningful impact on patientsu2019 lives. For an assigned product,The CMC submission managers support and may lead parts of the development of CMC strategy and plans; the planning, preparation, and submission of CMC regulatory documentationThis includes supporting the global CMC strategy for the Global Regulatory Plan, with input from regional regulatory representatives and CMC SMEs; preparing CMC documentation to support global regulatory filings, including liaising with GRT regional representatives and relevant SMEs to draft technical content for CMC.Youu2019ll be responsible for: Proactively managing CMC aspects of assigned projects including overseeing preparation and submission of global CMC submissions, including clinical trial applications.u00A0 Ensuring that CMC content is complete, well-written, and meets all relevant requirements.u00A0 Evaluating proposed manufacturing changes for global impact to ongoing and existing filings and provides strategic regulatory guidance for optimal implementation of changes.u00A0 Researching and interpreting global CMC regulations and providing regulatory guidance to the Quality, Manufacturing, Process Development and other functional groups. Representing the Regulatory Affairs CMC function on assigned cross-functional project teams. Supporting interactions with FDA and other global regulatory authorities for assigned project to ensure acceptance, rapid review and approval of clinical trial applications and other submissions which present CMC information.u00A0 Developing excellent relationships with internal functional groups, contract manufacturing organizations, and corporate partners.u00A0Education: BA/BS degree in life sciences in chemistry, molecular biology, or similar is desirable.Experience: 3-5 years of experience in Regulatory Affairs in a global pharmaceutical and/or biotechnology company with expertise clinical phase submissions and health authority interactions. Understanding of relevant drug development regulations and guidelines is essential. Outstanding interpersonal and communication (written and verbal) skills is required Strong writing and editing skills for technical documentation. Proficient with computer and standard software programs.u00A0 PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Company info

Sign Up Now - MiamiCrossing.com