Associate Director, Regulatory Affairs Submission Management
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.
Job Title: Associate Director, Regulatory Affairs Submission Management
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.
•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 and those of direct reports. 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 and for those of direct reports. Effectively assigns team membership, 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 develop solutions within the team, and provide guidance to direct reports in this area.
•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. If supervising others, demonstrates strong people management skills.
•Position accountability/scope includes: Projects are both self-initiated and assigned. Accountable for projects managed by direct reports. 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 junior 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 junior staff; accountable for training and coaching of direct reports.
•Provides input into strategic decisions of the department.
•Required Education: Bachelor’s Degree
•Preferred Education: Advanced Degree a plus. PMP and RAC certificates desirable.
•Required Experience: 8 years in pharmaceutical 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
•Preferred Experience: Knowledge of publishing-related software tools (e.g. Documentum/eCTDXPress/ISIPublisher/DocuBridge/Insight platform, ISI Toolbox, Adobe Acrobat, MS Word, etc.)
•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. 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)
Yes, 10 % of the Time
Job Level Code
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.