Associate Director, Regulatory Affairs Oncology Early Development
AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of both marketed products and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer.
AbbVie is focused on the discovery and development of novel oncology therapies. More than 1,000 AbbVie scientists, clinicians, and product developers with strong entrepreneurial roots work to combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. This role may be based in the San Francisco Bay Area or in Lake County, IL.
We are currently seeking a Regulatory Affairs Associate Director to join our growing regulatory team. In this role you would be the Global Regulatory Lead for multiple programs while contributing to the advancement of leading-edge cancer research as part of a nimble, biotech –like environment within a large, well established pharmaceutical company.
- Serve as the Global Regulatory Lead on multiple project teams and key sub-teams; provide support to other GRLs as needed.
- Develop and implement competitive and effective global regulatory strategies for multiple products including clinical, nonclinical and CMC aspects and identify potential risks associated with proposed strategies.
- Advise & guide project teams on the interpretation and application of relevant regulatory requirements and review processes.
- Collaborate with AbbVie regional and country regulatory affiliates to support ex-US clinical development activities.
- Present regulatory strategies and issues at team or governance meetings.
- Serve as primary Health Authority contact for assigned projects and foster positive and effective working relationships between project team members and regulatory authority reviewers.
- Prepare teams for and lead FDA (or other regulatory authority) meetings.
- Manage and participate in the creation, review, assembly and submission of regulatory documentation including clinical trial applications and amendments to these regulatory files, as appropriate.
- Ensure consistency/completeness/adherence to standards for all regulatory submissions.
- Coordinate and consult with other departments on the content, review of publication materials, and assembly of regulatory documentation.
- Support non-program specific projects as assigned such as department initiatives, business development assessments, clinical assessments and department training, etc.
- Bachelor’s degree or equivalent required in related discipline.
- 9+ years of experience in biotechnology or pharmaceutical industry, including R&D/related disciplines.
- 5+ years of experience in Regulatory Affairs within biotechnology/pharmaceutical industry.
- Demonstrated understanding of regulations and guidelines governing drug development; proven success in applying these to strategic drug development.
- Effective interfacing with regulators; has experience working with Health Authorities.
- Demonstrated leadership ability in team settings; effectively achieves outcomes in complex, matrix organizations.
- Strong written and verbal communication skills.
- Demonstrate expertise and knowledge of oncology and relevant indications.
- Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.
- Learns fast, grasps the 'essence' and can change the course quickly where indicated.
- Raises the bar and is never satisfied with the status quo.
- Creates a learning environment, opens to suggestions and experimentation for improvement.
- Embraces the ideas of others, nurtures innovation and manages innovation to reality.
Significant Work Activities
Yes, 15 % of the Time
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.