Senior Director, Regulatory Affairs Business Excellence
About The Position
The Senior Director of Regulatory Business Excellence is accountable to lead a cross functional team of Business Process Owners as they develop, implement, and improve regulatory business processes across AbbVie. These business processes include improvements in how we manage existing regulatory information, and how we integrate knowledge and data across AbbVie, especially within R&D, RA, and Operations. The Senior Director partners with R&D and Operations Quality Assurance bringing product and regulatory experience to activities for managing product actions and events. The Senior Director will have a leading role in AbbVie’s digital health initiatives.
Requirements
- Bachelor’s degree in science such as chemistry, biology, or pharmacy.
- Fifteen years of relevant experience including eight years in leadership positions.
- Experience should come from pharmaceutical development and commercialization with a wide background of responsibilities in regulatory, quality, manufacturing, or laboratory.
- Excellent writing and presenting skills.
- Expertise with interpretation of applicable laws, regulations, and guidances related to clinical trial and marketing applications, and ability to monitor and react to evolving US and global authority guidelines & regulations in drugs, biologics, medical devices and combination products.
- Strong interpersonal skills, oral and written communication skills, and ability to work effectively and build relationships with cross-functional teams, as well as influence many diverse internal and external business partners.
- Ability to direct and lead all aspects of work projects effectively within an environment that has rapidly changing processes, priorities, and deadlines
- Ability to prioritize and balance multiple tasks simultaneously to achieve goals and satisfy internal stakeholders.
- Creative thinker, motivational leader, strong manager.
Nice To Haves
- Advanced degree in science or law, such as MS, PhD, PharmD, or JD.
- A solid business process improvement background is key. The applicant should demonstrate this background with a combination of examples of improved business processes and training such as six sigma.
Responsibilities
- Lead the regulatory business process team and provide overall vision to developing and implementing more agile regulatory policies and processes.
- Negotiate with business partners on scope of shared business processes to create overall all for one AbbVie processes.
- Provide vision to Regulatory Operations and overall AbbVie leadership to develop and implement digital health initiatives such as those associated with medical device regulation.
- Lead activities with Quality Assurance to develop product action strategies.
- Establish a Continuous Improvement methodology that includes tools and processes to be shared with AbbVie Regulatory Affairs colleagues such that they develop key skills and attributes they need to be successful.
- Engage in external benchmarking and advocacy with regulatory agencies and external organizations to ensure efficacy, compliance, and competitive advantage of AbbVie processes. Partner with peers within Regulatory Affairs to share findings and influence change.
- Manage complex projects to ensure adherence to appropriate regulatory requirements and current industry best practice.
Benefits
- paid time off (vacation, holidays, sick)
- medical/dental/vision insurance
- 401(k)
- long-term incentive programs
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What This Job Offers
Job Type
Full-time
Career Level
Senior
