Director, Oncology Business Development and Global Regulatory Strategy

AbbVie Inc; North Chicago (IL); 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 global strategies for market approval, leading cross-functional teams, and ensuring compliance with regulatory requirements. Candidates should have extensive experience in regulatory roles and strong leadership skills. The position offers flexibility in location, including options for remote work.

Benefits

Paid time off

Insurance

401(k)

Incentive programs

Qualifications

• 7+ years in regulatory roles, including drug development experience.
• 5+ years in strategic leadership and project management.

Responsibilities

• Develops global strategies for market approval of products.
• Leads the Global Regulatory Product Team to mitigate regulatory risks.
• Manages projects and documentation of regulatory strategies.

Skills

Communication

Negotiation

Global Regulatory Strategy Development

Education

Bachelor's in life sciences

Advanced degree

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, ensures strategic messaging and content of global regulatory dossiers, and may lead the Labeling Regulatory Strategy Team (LRST). Serves 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 strong understanding of drug development and leadership behaviors, and develops acceleration strategies. Manages projects and documentation of regulatory strategies.

1. Interfaces and Leadership: Coordinates with LRST and AST to support cross-functional objectives. Leads the GRPT in developing global strategies aligned with regulations to meet business goals. Seeks expert advice when needed.
2. Regulatory Strategy and Content: Guides cross-functional teams to ensure clear strategic messaging in dossiers and responses to regulatory agencies.
3. Accountability and Policy: Ensures corporate goals are met. Acts as a key internal leader shaping regulatory policy and strategy. Develops and maintains risk assessments and communicates plans to stakeholders.
4. Regulatory Preparation: Prepares global regulatory strategies for assigned products. Leads risk mitigation planning and communicates impacts to relevant teams.
5. Independence and Development: Acts independently under supervision. May lead initiatives and provide coaching. May have direct reports and contribute to their performance management.
6. Regulatory Environment: Influences regulations and guidance. Analyzes legislation and provides organizational analysis with worldwide accountability.
7. Compliance and Policies: Follows record-keeping policies. Develops departmental policies if needed. Ensures alignment with senior management and presents regulatory assessments to executives.
8. Operational Decisions: Makes decisions to meet program objectives. Participates in professional associations and industry groups.
9. Budget and Initiatives: Manages budgets, resources, and chairs key initiatives, presenting outcomes to RA leadership.

Qualifications

• Required Education: Bachelor's in life sciences (pharmacy, biology, chemistry, pharmacology) or related.
• Preferred Education: Advanced degree and certifications are a plus.
• Required Experience: 7+ years in regulatory roles, including drug development experience in US&C, with 5+ years in strategic leadership and project management. Experience in complex, matrix environments and with government regulatory agencies.
• Required Skills: Strong communication, negotiation, and global regulatory strategy development experience.
• Preferred Experience: 10+ years in pharmaceutical regulatory activities, leading strategies in major regions (EU, Japan). Strong foundation in global drug development with business acumen.

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

Additional Information

Details about compensation, benefits, and company policies are included, emphasizing that pay ranges are estimates and may vary based on location and other factors. The company offers benefits like paid time off, insurance, 401(k), and incentive programs. AbbVie is an equal opportunity employer and provides accommodations for applicants with disabilities. For more information, visit the provided links.