Associate Director, Regulatory Affairs, Strategic Global Labeling
AbbVie
- North Chicago, IL
- Permanent
- Full-time
- Develops and directs regulatory label planning for or across assigned product group, area or operational activity and ensures they are in-line with business needs.
- Presents process, strategy, and product labeling at Senior level meetings (Global Regulatory Forum (GRF), Executive Leadership Committee (ELC), Common Technical Document (CTD) steering committee) and joint company meetings.
- Ensures that agreed regulatory labeling strategies or commercial concepts are efficiently implemented, and that strategies are maintained in-line with changing regulatory and business needs.
- Drives strategic labeling processes within teams based on knowledge of success with other products. Proactively recommends optimal label language based on competitive knowledge and knowledge of project data.
- Works cross functionally with teams such as Research & Development (R&D) and commercial to meet regulatory labeling needs. Provides labeling input for Risk Management Plans, Regulatory Strategic and Tactical Plan (RSTPs) and safety document.
- Comments on changing regulation and guidance, interfaces with outside regulatory agencies and trade associations and provides executive management with regulatory metrics/information.
- Develops and implements internal and external strategies to proactively address changes in the regulatory labeling environment.
- Under the direction of the Director, Global Labeling, provides regulatory leadership and expertise to licensing colleagues for labeling topics.
- Develops and manages an effective team. Conducts succession planning.
- Manages the work of direct reports. Trains new personnel and sets direction for development of new department processes/policies. Leads cross functional teams including regulatory, clinical and safety on labeling topics.
- Required Education: BS or BA degree in a technical area (biology, chemistry, engineering, microbiology, immunology, medical technology, pharmacology,)
- Preferred Education: Advanced degree preferred. Certifications a plus
- Required Experience: 8 years pharmaceutical, regulatory or industry related experience.
- Experience working in a complex and matrix environment. Strong communication skills, both oral and written
- Preferred Experience: 5+ years in industry related experience
- Understanding of regulatory concepts-knowledge of medical and regulatory terminology, guidelines, standards, etc.
- Experience developing and implementing successful global regulatory labeling strategies.
- Note: Higher education may compensate for years of experience
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.
- This job is eligible to participate in our long-term incentive programs.