Director, Oncology Business Development and Global Regulatory Strategy

AbbVie; South San Francisco (CA); Hybrid; USD 120,000 - 180,000; Full time

Job summary

An established industry player is seeking a Director for Oncology Business Development and Global Regulatory Strategy. This role is pivotal in shaping global strategies to secure market approvals and manage regulatory risks across the product lifecycle. The ideal candidate will have extensive experience in regulatory roles, demonstrating strong leadership and project management skills. Join a dynamic team that influences drug development and regulatory policies while ensuring compliance and alignment with corporate goals. This position offers a unique opportunity to make a significant impact in the pharmaceutical industry.

Qualifications

• 7+ years in regulatory roles with drug development experience.
• Experience in complex environments and with regulatory agencies.

Responsibilities

• Develop and implement global regulatory strategies for products.
• Lead cross-functional teams to ensure regulatory compliance.

Skills

Regulatory Strategy

Project Management

Drug Development

Leadership

Risk Assessment

Education

Bachelor's degree in life sciences

Advanced degree

Job description

Director, Oncology Business Development and Global Regulatory Strategy

Join to apply for the Director, Oncology Business Development and Global Regulatory Strategy role at AbbVie.

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), expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST and supporting teams. Proactively anticipates and mitigates regulatory risks and ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post-approval and throughout the product lifecycle. Demonstrates excellent understanding of drug development and leadership behaviors. Develops and implements acceleration strategies, manages projects, and documents regulatory strategies.

1. Interfaces with LRST and AST to lead and support cross-functional objectives. Leads the development of global strategies aligned with regulations to achieve business goals for development and marketed products. Seeks expert advice from functional stakeholders and senior personnel when necessary.
2. Leads cross-functional stakeholders and regulatory professionals to ensure inclusion of strategic messaging in dossiers and responses to regulatory agency requests.
3. Ensures corporate goals are met and leads regulatory policy and strategy for assigned products.
4. Prepares global regulatory product strategies, leads risk assessment and mitigation planning, and communicates plans to stakeholders.
5. Acts independently under guidance, participates in or leads initiatives, and expands TA knowledge. May have direct reports and contribute to performance management.
6. Influences regulation development and guidance, analyzes legislation, and provides analysis with worldwide accountability.
7. Follows policies for regulatory record keeping and may develop new policies within the RA department.
8. Aligns global regulatory strategies with senior management and presents assessments and recommendations to executive leadership. Informs management of issues, labeling outcomes, and risks, and represents ABBV in governance interactions.
9. Makes decisions on work processes and operational plans to meet program objectives. Participates in professional associations and industry groups.
10. Follows budget allocations, informs supervisor on resourcing, chairs key initiatives, and reports outcomes.

Qualifications

• Required Education: Bachelor's degree in life sciences or related field.
• Preferred Education: Advanced degree and certification are a plus.
• Required Experience: 7+ years in regulatory roles, including drug development experience in US & C region, with at least 5+ years in strategic leadership and project management. Experience working in complex, matrix environments and with government regulatory agencies.
• Preferred Experience: 10+ years in pharmaceutical regulatory activities, with leadership in multiple major regions (e.g., EU, Japan). Strong global drug development foundation with business acumen.

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