Submissions Manager, Regulatory Affairs
San Rafael, CA
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. OverviewBioMarin Global Regulatory Affairs (GRA)\u00A0is responsible for obtaining approval for new BioMarin products and ensuring that approval is maintained throughout the product lifecycle. GRA serves as the interface between the regulatory authorities and the program teams aiming to ensure that the project plan correctly anticipates what the regulatory authority will require before approving the product. It is the responsibility of GRA to keep abreast of current legislation, policies, guidelines and other regulatory intelligence. The RA department plays an important role in giving advice to the program teams on how best to interpret the regulatory legislation and guidelines.\u00A0BioMarin Regulatory Affairs RIMT function has a lead role in overall BioMarin Regulatory Submission system end user technical support.\u00A0 Specifically, this team develops and maintains submission processes, system templates, standards, guide sheets and training for all Regulatory submission types. This group also provides cross-department training to system user issues involved in the preparation of materials for submission.\u00A0SummaryThe Submissions Manager will manage submission and report content plans in multiple regions including US, international and global dossiers. In addition, Veeva RIM functional administration, oversight of technical support for users and submission development process training as needed.\u00A0ResponsibilitiesSubmission Planning Leadership and Communication Develop submission level content plans with the GRA lead, identifies submission deliverables and critical path Develop report level content plans with the functional lead, identifies report deliverables and critical path Provide guidance and address questions that team members may have during the team meetings or off-line regarding the use of Veeva RIM to manage their submission documents Confirm compliance of submission documents with regards to uploading documents within Veeva RIM Ensure operational excellence and efficiency through the ability to search and find documents, as well as expertise in the general use of Veeva RIM Advise the submission teams to ensure compliance with the defined business processes and address any business process related questions on the end-to-end process Provide expertise and support to ensure overall submission excellence and compliance through hypercare and system support activities Oversee Regulatory technology and process development activities as needed Manages updates to content plan templates, doc types and other Veeva RIM functional administrative activities Monitors and updates the overall submission processes Supports eDMS system updates to industry regulations that impact submission strategies and technologies Develop and author training materials and lead efforts to implement training to ensure optimal use of processes, and tools related to regulatory submission activities. Identify retraining of individuals, or updates to the training materials as needed Technical support Oversee applications and systems support, systems training programs, and supporting development projects within Regulatory Affairs Trouble shoot complex system user issues (such as interpreting technical validation errors)Additional Responsibilities Stay abreast of new guidances released by health agencies and coach team members on interpretation as needed Perform regulatory intelligence for information pertinent to Regulatory Operations and provide a preliminary assessment of impact of new or modified regulations and guidancesRequired Skills Experience in managing regional submission activities for a major filing, (IND, BLA, NDA, sNDA, DMF, Amendments, CTA, ASEAN etc.). including the management of global submission timelines\u00A0 Must be highly proficient in MS Office 365\u00A0(with an emphasis on MS Word) Strong knowledge of\u00A0eDMS\u00A0and (Veeva). Must have extensive experience with electronic submissions, specifically eCTDExcellent communication skills are required to interact effectively with regulatory affairs members and R&D colleagues in gathering the necessary information required for submissions, and to proactively address sensitive issuesApplies good judgment and demonstrates initiative to resolve issuesKnowledgeable on current regulatory submission standards and industry best practiceExperience working with electronic document management systemsEducation & Experience Degree in health or life sciences, including chemistry, molecular biology, or similar. Masters/Bachelors acceptable with relevant experience 2 year experience with PhD; 4 years with Masters, 6 with bachelor\u2019s degrees Must have extensive experience with global electronic submissions, specifically eCTD. 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.
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