Director, Oncology Business Development and Global Regulatory Strategy

AbbVie Inc; South San Francisco (CA); Remote; USD 150,000 - 200,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a Director for Oncology Business Development and Global Regulatory Strategy. This role involves developing strategies for product approval, leading teams, and ensuring compliance with regulatory requirements. Candidates should have extensive experience in regulatory affairs and drug development, with a strong leadership background. The position offers opportunities for mentorship and strategic influence within the organization.

Benefits

Paid time off

Health insurance

401(k)

Participation in incentive programs

Qualifications

• 7+ years in regulatory affairs, including drug development experience in US & C regions.
• 5+ years in strategic leadership and project management.

Responsibilities

• Develops and implements global strategies for market approval.
• Leads the Global Regulatory Product Team.
• Manages compounds throughout all development phases.

Skills

Leadership

Strategic Planning

Project Management

Regulatory Affairs

Education

Bachelor's in life sciences

Advanced degree and certifications

Job description

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and TikTok.

Job Description

The Director, Oncology Business Development and Global Regulatory Strategy is responsible for developing and implementing global strategies to secure and maintain market approval for products in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Ensures strategic messaging and content of global regulatory dossiers, expands TA knowledge, and may lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST and supporting teams, proactively mitigating risks and ensuring compliance with global regulatory requirements. Manages compounds throughout all development phases, including post-approval and lifecycle management. Demonstrates leadership in drug development and strategic planning, develops acceleration strategies, and manages regulatory projects and documentation.

1. Interfaces with the LRST and AST to align on cross-functional objectives. Leads the development of global regulatory strategies in line with regulations to meet business goals for development and marketed products. Seeks expert advice from functional stakeholders and senior personnel as needed.
2. Leads cross-functional teams to ensure strategic messaging is clear and included in global regulatory dossiers and responses to agency requests.
3. Ensures corporate goals are met, leading regulatory policy and strategy for assigned products.
4. Prepares global regulatory strategies, risk assessments, and mitigation plans for assigned products, communicating effectively with stakeholders.
5. Acts independently under guidance, participating in or leading regulatory initiatives, and providing coaching and mentorship to team members. May have direct reports and contribute to performance management.
6. Analyzes legislation, regulations, and guidance, providing insights and analysis with worldwide accountability.
7. Follows company policies for record-keeping, developing policies within the RA department as needed.
8. Aligns regulatory strategies with senior management, presenting assessments and recommendations, and informing management of issues and risks.
9. Makes operational decisions to achieve program objectives and participates in professional industry groups.
10. Manages budgets and project resourcing, chairs or sponsors key initiatives, and reports outcomes to leadership.

Qualifications

• Required Education: Bachelor's in life sciences or related field.
• Preferred Education: Advanced degree and certifications are a plus.
• Required Experience: 7+ years in regulatory affairs, including drug development experience in US & C regions, with 5+ years in strategic leadership and project management. Experience in complex, matrix environments and with government regulatory agencies.
• Preferred Experience: 10+ years in global pharmaceutical regulatory activities, leading strategies in multiple regions such as EU or Japan, with strong drug development and business acumen.

This position can be located in Lake County, IL, Waltham, MA, South San Francisco, CA, or Remote.

Additional Information

• The compensation range is based on job grade, location, and other factors, and may be adjusted.
• We offer comprehensive benefits including paid time off, health insurance, 401(k), and participation in incentive programs.
• Pay is not considered wages until earned and vested. Compensation elements remain at the company's discretion.

AbbVie is an equal opportunity employer committed to integrity, innovation, and community service. For more information, visit here. Applicants seeking accommodations can find more information here.