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 Associate Director RA, Submission Management, independently and through others, leads high impact, highly complex submission projects involving multiple cross-functional regulatory submission teams and new initiatives. 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. May supervise others, and in this capacity prioritizes and assigns resources across projects. Provides input into strategic decisions of the department. Responsibilities: Independently manages/provides operational oversight to ensure timely, high quality regulatory submissions. Drives the formulation of submission project scopes, timelines and deliverables for own projects. 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, for own projects. Effectively plans and prioritizes workload, and follows up to ensure success. 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, including governing bodies. Anticipates obstacles and develops solutions within the team. Provides leadership 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 and implements efficiencies, business process improvements and cost reductions. Demonstrates team leadership skills and ability to influence without direct authority. Proactively builds and maintains positive relationships internally and externally. Position accountability/scope: - Projects are both self-initiated and assigned - Does not require direct supervision. Project progress is reviewed at major milestones for Sr. Management review with minimal direction. Identifies opportunities for process improvements or cost savings, and reviews proposals from staff. May sponsor, lead or participate on internal or cross-functional project teams to update business processes. - Provides estimates of activities with budgetary impact. - Trains or mentors less- experienced staff. - Provides input into strategic decisions of the department. Qualifications Required Education: Bachelor’s Degree Preferred Education: Advanced Degree a plus. PMP and RAC certificates desirable. Note: Years of experience may also compensate for lower education. Required Experience: 10 years bio-pharmaceutical regulatory or industry related experience Experience working in a complex and matrix environment Strong communication skills, both oral and written Strong business acumen and negotiation skills Proven leadership skills and presence Preferred Experience: Knowledge of publishing-related software tools 5+ years in creation of global regulatory submissions that involved planning and compilation of complex submissions including both electronic and paper submissions 2+ years in a leadership role with strong project management skills Note: Higher education may compensate for years of experience. Significant Work Activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Travel No 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.