Manager, Regulatory Affairs Submission Management

About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

The Manager, Regulatory Affairs Submission Management, manages medium to high impact, complex submission projects involving multiple cross-functional regulatory submission teams.  With input from the submission teams, the Submission Manager 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. Individual is recognized as a discipline expert and resource in regulatory affairs operations.

• 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

Qualifications

• 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)
Travel
Yes, 5 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.