Regulatory Affairs Senior Associate / Manager, Oncology Early Development

Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products - Imbruvica, Venclexta, and Empliciti - and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer.

In AbbVie Oncology Early Development (OED), we strive to develop a rich and innovative pipeline of transformative cancer therapies by uniquely combining our deep knowledge in core areas of biology with cutting-edge technologies, and working together with our partners - scientists, clinical experts, industry peers, and patients - to discover and develop medicines that drive transformational improvements in cancer treatment.
The Regulatory Affairs Senior Associate/Manager provides support to the Global Regulatory Leader for regulatory activities for products in the assigned portfolio. Supports all regulatory activities (clinical, non-clinical and CMC) associated with the development, for designated products. Provides regulatory support for products by interacting with project teams, and supporting IND and CTA related submissions, as appropriate.

Responsibilities:

• Demonstrates ability to apply clinical, non-clinical and CMC understanding and disease state knowledge in a regulated environment. Identifies and communicates routine Health Authorities filing needs.
• Responsible (with manager's oversight as needed) for educating internal customers on Regulatory issues including clinical development, non-clinical, Discovery, CMC, commercial, public affairs, legal and others who contribute to regulated communication or communications that could be regulated.
• Serve as the Regulatory Affairs representative on key sub-teams
• Maintains thorough knowledge of product data and key product issues across multiple programs.
• Prepares routine submissions in compliance with department and regulatory requirements and guidelines. Assists with larger or more complex submissions.
• Functions independently in decision making for routine issues. In conjunction with manager, reviews complex issues and problem resolution successes and setbacks to assist in future problem solving applications/options.
• Completes tasks and disseminates pertinent information to appropriate inter-departmental areas.
• May serve as department representative on cross-functional initiatives.
• Responsible for supporting the department, division and company's strategic direction and goals
• With management guidance participates in the problem solving process by monitoring issues and implementing strategies for resolution. Analyzes and interprets information, impacting regulatory decisions
• Consistently exercises good judgment in the application of policies and regulations. Works well with other individuals and departments in solving problems

• A minimum of a Bachelor's Degree is required, preferably in a science/relevant health-related discipline, with a minimum of 1-2 years (Sr. Associate) or 3-4 years (Manager) regulatory affairs experience.
• Basic understanding of regulations and guidelines related to drug development and registration is required.
• Demonstrated ability to handle multiple projects is required.
• Excellent English verbal and written communication skills are required. Knowledge of regulatory requirements related to submissions is preferred.
• Ability to review and contribute to the compilation of IND/CTA dossier components is preferred.
• Basic understanding of scientific and medical principles as they apply to oncology products is preferred.