The Manager, Regulatory Affairs Submission Management, manages high impact, complex submission projects involving multiple cross-functional regulatory submission teams. 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.
- Independently manages/provides operational oversight to ensure timely, high quality regulatory submissions. Actively contributes to the formulation of submission project scopes, timelines and deliverables. Plans and negotiates publishing timelines with the teams and partner with publishing resource managers to ensure all required resources are available to meet submission timelines.
- 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 develop solutions within the team.
- Actively contributes to 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: Minimal supervision. 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
- Provides recommendations on project decisions and direction. Identifies opportunities for process improvements or cost savings. May lead or participate on internal project teams to update business processes.
- Provides estimates of activities with budgetary impact
- May train or mentor junior staff
- Required Education: Bachelor’s degree or High School diploma or equivalent and 5 years related experience
- Preferred Education: Bachelor’s degree. PMP and RAC certificates desirable
- Required Experience: 6 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
- Proven leadership skills and presence
- NOTE: Higher education may compensate for years of experience. Years of experience may also compensate for lower education.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Keyboard use (greater or equal to 50% of the workday)
Job Type: Experienced