Director, Oncology Business Development and Global Regulatory Strategy

BioSpace; North Chicago (IL); Remote; USD 120,000 - 180,000; Full time

Job summary

An established industry player is seeking a Director of Oncology Business Development and Global Regulatory Strategy. This pivotal role involves developing and implementing global strategies to secure market approval for innovative products. You will lead cross-functional teams, ensuring compliance with regulatory requirements while managing projects through all development phases. The ideal candidate will possess extensive experience in regulatory affairs and drug development, with a strong background in strategic leadership. Join a mission-driven organization that is dedicated to making a positive impact on global health.

Qualifications

• 7+ years in regulatory affairs and drug development.
• Experience in strategic leadership and complex matrix environments.

Responsibilities

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

Skills

Regulatory Affairs

Drug Development

Strategic Leadership

Communication Skills

Education

Bachelor's in Life Sciences

Advanced Degree

Job description

Director, Oncology Business Development and Global Regulatory Strategy

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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, as well as 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 in global dossiers. May lead the Labeling Regulatory Strategy Team (LRST) and serves as the primary regulatory interface with AST and supporting teams. Ensures compliance with global regulatory requirements, manages products through all development phases, and develops acceleration strategies. Manages projects and documents regulatory strategies.

1. Interfaces with LRST and AST to support cross-functional objectives. Leads the development of global strategies aligned with regulations to meet business goals. Seeks expert advice when necessary.
2. Leads cross-functional stakeholders and regulatory teams to ensure clear strategic messaging in dossiers and responses to authorities.
3. Ensures corporate goals are met and acts as a key internal regulatory leader.
4. Prepares global regulatory strategies, leading risk assessment and mitigation planning, and communicates plans to stakeholders.
5. Acts independently under supervision, may lead initiatives, and provides coaching and mentoring. May have direct reports.
6. Influences regulatory regulations and guidance, analyzing legislation and providing organizational analysis.
7. Follows record-keeping policies and may develop departmental policies.
8. Aligns global strategies with senior management, presents assessments, and informs management of issues and risks.
9. Makes decisions on work processes and participates in professional industry groups.
10. Follows budget and project resourcing, chairs or sponsors GRS initiatives, and reports outcomes.

Qualifications

• Required Education: Bachelor's in life sciences (pharmacy, biology, chemistry, pharmacology) or related.
• Preferred Education: Advanced degree and certification are a plus.
• Required Experience: 7+ years in regulatory affairs, drug development experience in US & C, 5+ years in strategic leadership, experience in complex matrix environments, and strong communication skills.
• Preferred Experience: 10+ years in pharmaceutical regulatory activities, leading regulatory strategies in major regions like EU or Japan, with a solid foundation in global drug development and business acumen.

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