Director, RA 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.
The Director, RA Submission Management, combines knowledge of scientific, regulatory, process, technology and business issues to enable product applications to be published, submitted, tracked and successfully reviewed by regulatory agencies worldwide. Additionally, the individual will develop and supervise regulatory professionals including managers of managers. The individual has division level influence and is generally considered a key opinion leader and an expert resource both within AbbVie and externally. The individual may influence changing regulations and guidance, interface with outside regulatory agencies and trade associations and provide executive management with Submission Management metrics/information. The individual may plan, direct, coordinate and control the Submission Management activities related to products worldwide.
• Manages department and provides direction and guidance to exempt, non-exempt and/or supervisory personnel who exercise significant latitude and independence in their assignments. Evaluates performance of and assists in career development planning for subordinates. Mentors less-experienced staff internal and external to the department. Forecasts and monitors department resource requirements including personnel, travel and capital expenditures.
• Builds and adapts global processes, systems and resources in support of the development and ongoing management of global submission management function. Ensures resources and capacities are consistently available and utilized across all sites to meet business requirements.
• Develops and directs key initiatives in collaboration with other functions within Regulatory Affairs as well as with other functions such as IT, Finance, HR and Pharmacovigilance & Patient Safety.
• Monitors and assesses the impact to the business and supporting technologies of any regulatory change impacting submission operations and registration management.
• Monitors and assesses compliance with processes or systems and ensure appropriate action is taken.
• Makes and executes operational recommendations and decisions with a strategic perspective. Drives continuous process improvement. Anticipates emerging issues and develops solutions with other members of management and stakeholders.
• Is a key member of the leadership team, responsible for designing short-term and long-term plans, demonstrating effective problem solving and decision making, learning and adjusting behaviors based on prior results/experience and building the overall culture.
• Determines and establishes organizational structure and supervisory relationships subject to top management approval.
• Manages portfolio of projects through others. Assesses risk across projects. Oversees risk/mitigation to ensure portfolio success.
• Delivers executive level communications (both written and formal presentations).
•Required Education: Bachelor’s Degree
•Preferred Education: Advanced Degree. PMP and/or RAC certification a plus
•Required Experience: 12+ years pharmaceutical or industry related experience. 5+ years in process improvement, regulated environment operations. Proven 7-10 years in a leadership role with strong management skills
• Experience working in a complex and matrix environment
• Strong communication skills, both oral and written
• Strong business acumen and negotiation skills
• Preferred Experience: Previous Submission Management and publishing experience preferred
• Knowledge of document management, submission publishing, submission management and archiving systems. Global Regulatory Operations experience
• 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, 5 % 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.