Director II, Oncology Business Development and Global Regulatory Strategy

Allergan; Greenlawn (NY); Remote; USD 150,000 - 220,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a Director of Oncology Business Development and Global Regulatory Strategy. This role involves developing global strategies to secure market approval for oncology products, leading cross-functional teams, and ensuring compliance with regulatory requirements. The ideal candidate will have extensive experience in regulatory affairs and drug development, with a strong leadership background.

Benefits

Paid time off

Medical/dental/vision insurance

401(k)

Short-term and long-term incentive programs

Qualifications

• 7+ years in regulatory affairs, including drug development experience in US & Canada.
• 5+ years in strategic leadership and project management.
• Experience in complex, matrix environments and with government regulatory agencies.

Responsibilities

• Develops and implements global strategies for market approval of products.
• Leads the Global Regulatory Product Team and ensures compliance with regulations.
• Prepares global regulatory strategies and communicates plans to stakeholders.

Skills

Regulatory Affairs

Project Management

Leadership

Drug Development

Education

Bachelor's in life sciences

Advanced degree and certification

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 us on X, Facebook, Instagram, YouTube, LinkedIn, and TikTok.

Job Description

The Director of 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 products through all development phases, including post-approval and lifecycle management, demonstrating leadership and understanding of drug development. Develops acceleration strategies, manages projects and documentation related to 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 for development and marketed products. Seeks expert advice when necessary.
2. Leads cross-functional teams to ensure strategic messaging is clear and included in regulatory dossiers and responses.
3. Ensures corporate goals are met, acting as a key internal leader and driver of regulatory policy and strategy.
4. Prepares global regulatory strategies for assigned products, leading risk assessments and mitigation strategies, and communicates plans to stakeholders.
5. Acts independently under the guidance of senior regulatory leaders, participates or leads initiatives, and mentors team members. May have direct reports.
6. Influences regulatory regulations and guidance, analyzing legislation and providing organizational analysis with worldwide accountability.
7. Follows policies for regulatory record keeping, develops policies within the RA department, and ensures compliance.
8. Aligns global regulatory strategies with senior management, presents assessments and recommendations, and informs management of issues, risks, and mitigations. Represents ABBV in regulatory interactions.
9. Makes operational decisions to achieve program objectives, participates in industry groups, and manages budgets and resources.

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, including drug development experience in US & Canada, with 5+ years in strategic leadership and project management. Experience in complex, matrix environments and with government regulatory agencies.
• Preferred Experience: 10+ years in pharmaceutical regulatory activities, leading strategies in multiple major regions (EU, Japan). Strong global drug development background.

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

Additional Information

• The compensation range is based on the job grade and geographic location, may change, and is not a guarantee of actual pay.
• We offer benefits including paid time off, medical/dental/vision insurance, and 401(k).
• This role is eligible for short-term and long-term incentive programs.
• All compensation details are at the company's discretion until paid.
• AbbVie is an equal opportunity employer, committed to diversity and inclusion. For more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html.
• Applicants seeking accommodations can find more information at https://www.abbvie.com/join-us/reasonable-accommodations.html.