About this role
The Manager, Regulatory Affairs Submission Management, manages high impact, complex submission projects involving multiple cross-functional regulatory submission teams.
Objectives
With input from the submission teams, this individual establishes and maintains submission content planners and associated timelines, facilitates tactical submission team meetings, prepares content planners for publishing, interfaces with publishing vendor, and fulfills Submission Management functions on Project Teams in support of Development, Marketing, and post-marketing regulatory authority applications. This individual is recognized as a discipline expert and resource in regulatory affairs submission management.
Key responsibilities
Independently manages high impact (with respect to internal visibility, risk, complexity and criticality) submission projects to ensure the timely delivery of high quality dossiers that meet technical specifications defined by regulatory authorities and can be easily navigated and reviewed by a regulatory agency. Acts as primary Submission Management interface with project teams providing guidance and communication of established submission processes and standards. Plans and negotiates submission project scope, publishing timelines and deliverables.Plans and conducts submission team meetings. Expedites, manages, and coordinates multiple concurrent interrelated activities for submission projects and/or for multiple products in the delivery of complex published submissions within the required timelines. Anticipates obstacles and develop solutions within the team.Coordinates submission publishing with offsite publishers/provides notification to ensure all required resources are available to meet submission timelines. Prepares content planner for publishing and works with vendor to resolve publishing issuesFacilitates the creation or procurement of submission content deliverables such as cover letters and formsPerforms detailed quality reviews of published output to ensure compliance with Regulatory Standards and Health Authority guidance’s including verification of content, bookmarks, hypertext links and tables of content in complex submissions. Facilitates team reviews.Actively contributes to the development of optimal business processes and standards within the department to ensure high levels of customer support and to achieve high quality submissions. Creates, implements and finalizes internal process and standards documents relating to publishing and publishing deliverables.Suggests and implements process improvements. May recommend changes to software and business processes to support changes in regulations that support complex submissions May lead or participate on internal project teams to update business software.Demonstrates team leadership skills and ability to influence without direct authority. Builds and maintains positive relationships internally and externally.Position accountability/scope:Minimal supervision required(People Manager)Receives project assignments from manager but has responsibility for managing own projectsReviews project progress with manager on a regular basis with direction provided on follow-upProvides estimates of activities with budgetary impact.Trains, mentors and may supervise the work of less experienced staff.
Qualifications
Bachelor’s degree
Note: Years of experience may also compensate for lower education.
PMP and RAC certificates desirable.
Competencies
Pharmaceutical or industry related experienceExperience working in a complex and matrix environmentStrong communication skills both oral and writtenExperience in Regulatory Affairs preferred but may consider QA, R&D/support, Scientific affairs, operations or related areaExperience in Regulatory Operations, including regulatory submission project management and/or submission publishing is preferred.Proven leadership skills and presence アッヴィは、機会均等を重視する雇用主であり、誠実な企業活動、革新の推進、人々の生活への貢献、そして地域社会への貢献に努めています。雇用機会均等に向けて、障がいを持つ方々も積極的に支援しています。