Director, Oncology Business Development and Global Regulatory Strategy

BioSpace; North Chicago (IL); Remote; USD 150,000 - 200,000; Full time

Job summary

A leading company in the healthcare sector is seeking a Director of Oncology Business Development and Global Regulatory Strategy. This role involves developing global strategies for regulatory approval, leading cross-functional teams, and influencing regulatory policies. Ideal candidates will have extensive regulatory experience and strong leadership skills. The position offers flexibility in location, including options for remote work.

Qualifications

• 7+ years of regulatory experience, including drug development in US & C regions.
• Experience in strategic leadership roles.

Responsibilities

• Develop and implement global strategies for market approval.
• Lead cross-functional teams for regulatory dossiers.
• Manage budgets and resource planning.

Skills

Communication

Negotiation

Global Regulatory Strategy Development

Education

Bachelor's degree in life sciences

Advanced degree and certification

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 including immunology, oncology, neuroscience, and eye care, along with 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). Acts as the primary regulatory interface with AST and supporting teams, proactively 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 a strong understanding of drug development and leadership behaviors aligned with level expectations. Develops and executes acceleration strategies, manages projects, and documentation of regulatory strategies.

Key Responsibilities

1. Interface with LRST and AST to support cross-functional objectives. Lead the development of global strategies aligned with regulations to meet business goals. Seek expert advice when needed.
2. Lead cross-functional teams to ensure strategic messaging in global regulatory dossiers and responses to agency requests.
3. Ensure corporate goals are met, lead regulatory policy and strategy for assigned products.
4. Prepare global regulatory strategies, lead risk assessments, and communicate plans to stakeholders.
5. Operate independently under guidance, participate in or lead initiatives, and provide coaching and mentoring. May have direct reports and contribute to team performance management.
6. Influence regulation development, analyze legislation, and provide organizational analysis worldwide for assigned products.
7. Follow record-keeping policies, develop departmental policies if needed, and ensure compliance.
8. Align global regulatory strategies with senior management. Present assessments and recommendations to executive management. Inform relevant teams of issues and risks, representing ABBV's regulatory position in governance interactions.
9. Make decisions on work processes and operational plans to achieve program objectives. Participate in professional associations and industry groups.
10. Manage budgets, resource planning, and chair key initiatives, presenting outcomes to RA leadership.

Qualifications

• Bachelor's degree in life sciences or related field; advanced degree and certification preferred.
• 7+ years of regulatory experience, including drug development in US & C regions, with at least 5 years in strategic leadership roles.
• Experience working in complex, matrix environments with multiple stakeholders.
• Strong communication, negotiation, and global regulatory strategy development skills.
• Preferred: 10+ years in pharmaceutical regulatory activities with leadership in multiple major regions.

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