Director II, Oncology Business Development and Global Regulatory Strategy

AbbVie Inc; North Chicago (IL); Hybrid; USD 150,000 - 220,000; 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 market approval of products, leading regulatory teams, and ensuring compliance with global regulations. Candidates should possess significant experience in regulatory affairs and drug development, with a strong emphasis on strategic leadership and communication skills.

Qualifications

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

Responsibilities

• Develop and implement global regulatory strategies for products.
• Lead cross-functional stakeholders to ensure clear messaging in global dossiers.
• Analyze legislation and provide worldwide regulatory analysis.

Skills

Regulatory Affairs

Drug Development

Strategic Leadership

Communication

Education

Bachelor's degree 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), 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 risks, and ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post-approval and throughout the product lifecycle. Demonstrates strong understanding of drug development and leadership behaviors, develops acceleration strategies, and manages projects and documentation of regulatory strategies.

1. Interfaces with the LRST and AST to support cross-functional objectives. Leads the development of global strategies aligned with regulations to achieve business goals, seeking expert advice when necessary.
2. Leads cross-functional stakeholders and regulatory professionals to ensure clear strategic messaging in global dossiers and responses to agency requests.
3. Ensures corporate goals are met, influencing regulatory policy and strategy for assigned products.
4. Prepares global regulatory strategies, leading risk assessments and mitigation strategies, and communicates plans to stakeholders.
5. Acts independently under supervision, participates in initiatives, and provides coaching and mentoring. May have direct reports and contribute to team performance management.
6. Analyzes legislation, regulations, and guidance, providing worldwide regulatory analysis for assigned products.
7. Follows record-keeping policies, develops internal policies if needed, and ensures team compliance.
8. Aligns global 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. Follows budget guidelines, manages project resourcing, chairs initiatives, and reports outcomes.

Qualifications

• Required Education: Bachelor's degree in life sciences or related fields.
• Preferred Education: Advanced degree and certifications are a plus.
• Required Experience: 7+ years in regulatory affairs, drug development experience in US & C region, 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 global drug development background.

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

Additional Information

• The salary range is based on geographic location and may vary. Compensation includes benefits, bonuses, and incentives.
• AbbVie is an equal opportunity employer committed to diversity and inclusion.
• For more details, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html.
• Applicants in US & Puerto Rico can find accommodations information at https://www.abbvie.com/join-us/reasonable-accommodations.html.