The Specialist, Regulatory Affairs Submission Management, with manager support as needed, manages low to medium impact, simple to moderately complex submission projects involving multiple cross-functional regulatory submission teams. With input from the submission teams and their supervisor, the Specialist establishes and maintains submission planners and associated timelines, facilitates tactical submission team meetings, and represents Submission Operations on Global Regulatory Project Teams, for assigned products.
- With manager support as needed, manages/provides operational oversight on simple to moderately complex submission projects, and ensures timely, high quality regulatory submissions. Participates in the development of project plans using established templates.
- Plans and negotiates publishing timelines with the teams.
- Effectively manages multiple projects and competing priorities.
- Acts as RA Submissions interface with project teams providing guidance and communication of established submission processes and standards.
- Plans and conducts submission team meetings.
- Communicates effectively verbally and in writing with diverse audiences and across various levels within the organization.
- Identify obstacles and work with manager/mentor to develop solutions for the team.
- Participates in the development of optimal business processes and practices within the department to ensure high levels of customer support and to achieve high quality submissions.
- Demonstrates submission team leadership skills and ability to influence without direct authority. Builds and maintains positive relationships internally and externally.
- Position accountability/scope:
- Some supervision of projects and assistance with priority setting required
- Receives project assignments from manager but has responsibility for managing own projects
- Reviews project progress with manager on a regular basis with direction provided on follow-up
- Identifies opportunities for process improvements. May participate on internal project teams to update business processes.
Education:
- Bachelor’s degree;
- PMP and/or RAC certificates a plus.
Experience:
- Solid pharmaceutical or industry related experience;
- Experience working in a complex and matrix environment;
- Strong English communication skills both oral and written is mandatory;
- Experience in Regulatory Affairs preferred but may consider QA, R&D/support, Scientific affairs, operations or related area;
- Experience in Regulatory Operations, including regulatory submission project management and/or submission publishing is preferred.
A AbbVie é uma empresa de oportunidades igualitárias e está empenhada em operar com integridade, impulsionando a inovação, transformando vidas e servindo a nossa comunidade. Empregador de Igualdade de Oportunidade/Veteranos/Deficientes.
