The Senior Associate, Regulatory Affairs Submission Management, manages simple to moderately complex submission projects involving multiple cross-functional regulatory submission teams. With input from the submission teams and their supervisor, the Senior Associate 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, manages/provides operational oversight to ensure 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 primary Submission Operations 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.
• Anticipates obstacles and develops solutions within 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. Identifies opportunities for efficiencies, business process improvements and cost reductions.
• Demonstrates team leadership skills and ability to influence without direct authority. Builds and maintains positive relationships internally and externally.
• Position accountability/scope includes 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 or cost savings. May participate on internal project teams to update business processes. Provides support in on-boarding new staff
• with direction provided on follow-up
• Identifies opportunities for process improvements or cost savings. May participate on internal project teams to update business processes. Provides support in on-boarding new staff

• Required Education: High School diploma or equivalent and 4 years industry related experience
• Preferred Education: Bachelor’s degree. PMP and RAC certificates a plus
• Required Experience: 5 years pharmaceutical or industry related experience
• Experience working in a complex and matrix environment. Strong communication skills both oral and written
• Preferred Experience: 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
• NOTE: Higher education may compensate for years of experience. Years of experience may also compensate for lower education