Senior Manager / Associate Director, Strategic Global Labeling (Oncology)

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 Regulatory Affairs, Strategic Global Labeling, combines the knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. Influences the department and is recognized as an expert resource on label topics. Ensures that labeling data is identified, obtained and effectively presented for the registration of products worldwide. Represents the organization at Senior level meetings regarding Target Product Label (TPL), Company Core Data Sheets (CCDS), US Package Insert (USPI), European Summary of Product Characteristics (EU SPCs), and other Global Labeling. Under the direction of the Director of Strategic Global Labeling, establishes labeling policy compliant with changing regulatory environment. Manages labeling staff. Develops and supervises regulatory personnel. 

Responsibilities:

• 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 (Regulatory Strategy Review (RSR), Executive Leadership Committee (ELC), Common Technical Document (CTD) steering committee, and joint company meetings as applicable. 
• 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 labeling guidance, competitive knowledge, and knowledge of product 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, safety documents, briefing books, and dossier documents. 
• 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, Strategic 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
• Works with Labeling Leadership on development of new or updates to existing department processes/policies. Leads cross-functional training activities.

Qualifications

Qualifications:

• 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

*Position flexible based on years of experience 

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 5 % of the Time
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.