Senior Manager/Associate Director, Regulatory Affairs

Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products — Imbruvica®, Venclexta™, and Empliciti™ — 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 expanding its oncology hub on the West Coast, with three sites in the San Francisco Bay Area (Redwood City, South San Francisco, and Sunnyvale) 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 across these three sites. They 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

The Senior Manager /Associate Director, Regulatory Affairs will develop and implement global regulatory strategies to support the development of multiple oncology early development assets. This role provides leadership in the strategic guidance and execution of regulatory concepts within cross-functional project teams and supports interactions with global health authorities and corporate partners with regulatory deliverables. This position is based at AbbVie in the Redwood City, CA location.

Essential Duties and Responsibilities:

• Develop and implement competitive and effective global regulatory strategies for various oncology products including clinical, nonclinical and CMC aspects and identify potential risks associated with proposed strategies
• Manage and participate in the creation, review, assembly and submission of regulatory documentation such as INDs and its international equivalents, expedited program designations, orphan drug applications, annual reporting, pediatric plans, and amendments related to clinical trials
• Coordinate and consult with subject matter experts on the content, review of publication/promotional materials, and assembly of regulatory documentation
• Serve as primary Health Authority contact for assigned projects
• Provide advice and guidance to project teams on the interpretation and application of relevant regulatory requirements and review processes.
• Present global regulatory strategies and issues at team or governance meetings
• Collaborate with regional and country regulatory affiliates to support international development activities
• Coordinate and prepare for Health Authority meetings and associated briefing document preparation
• Attend relevant functional area and project team meetings, including nonclinical, clinical, and regulatory sub teams