Director, Oncology Business Development and Global Regulatory Strategy

AbbVie; North Chicago (IL); Hybrid; USD 130,000 - 190,000; Full time

Job summary

An established industry player seeks a Director of Oncology Business Development and Global Regulatory Strategy. This pivotal role involves developing and executing strategies to secure market approval for oncology products. You will lead the Global Regulatory Product Team, ensuring compliance with global regulations while managing products through all development phases. This position offers a unique opportunity to influence regulatory policies and mentor team members in a dynamic environment focused on innovation and healthcare solutions. Join a team committed to addressing serious health issues and making a meaningful impact.

Benefits

Health Insurance

401(k)

Incentive Programs

Qualifications

• 7+ years of regulatory experience in drug development.
• Leadership in regulatory strategy and project management.

Responsibilities

• Develop global regulatory strategies aligned with business goals.
• Lead regulatory compliance and manage documentation throughout product lifecycle.

Skills

Regulatory Strategy

Project Management

Cross-functional Team Leadership

Compliance Management

Education

Bachelor’s degree in life sciences

Advanced degrees and certifications

Job description

Director, Oncology Business Development and Global Regulatory Strategy

Join us at AbbVie as a Director, Oncology Business Development and Global Regulatory Strategy.

Company Overview

AbbVie's mission is to discover and deliver innovative medicines that address serious health issues and future medical challenges. We focus on key therapeutic areas including immunology, oncology, neuroscience, and eye care, along with our Allergan Aesthetics portfolio. For more information, visit www.abbvie.com.

Job Description

The Director will develop and execute global strategies to secure and maintain market approval for products in the oncology therapeutic area. Responsibilities include leading the Global Regulatory Product Team (GRPT), expanding therapeutic area knowledge, managing regulatory dossiers, and ensuring compliance with global regulations. The role involves managing products through all development phases, including post-approval, and leading regulatory teams and strategies.

1. Interface with cross-functional teams to develop global regulatory strategies aligned with business objectives.
2. Lead the preparation of regulatory strategies and responses to agency requests.
3. Ensure regulatory compliance and mitigate risks proactively.
4. Manage regulatory projects and documentation throughout product lifecycle.
5. Lead and mentor team members, influence regulatory policies, and participate in industry initiatives.

Qualifications

• Bachelor’s degree in life sciences; advanced degrees and certifications preferred.
• Minimum 7+ years of regulatory experience, including drug development in US and C regions.
• Proven leadership in regulatory strategy with strong project management skills.
• Experience in global markets such as EU or Japan is advantageous.

Location

This position can be based in Lake County, IL; Waltham, MA; South San Francisco, CA; or remotely.

Additional Information

Compensation will depend on location and experience. Benefits include health insurance, 401(k), and incentive programs. AbbVie is an equal opportunity employer committed to diversity and inclusion.