Director, Regulatory Affairs, Oncology Early Development

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. AbbVie is also expanding their expertise through partnering with companies leading the way in emerging biologic technologies including oncolytic virus' and CAR-T cells.

The Associate Director/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.

Key Responsibilities Include:

• 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 and publication 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

Position will be filled at a level commensurate with experience

• Bachelor degree in a life sciences, chemistry, or related discipline. Advanced degree preferred
• 8 to 12 years of experience in Regulatory Affairs (minimum 4 years within oncology) in the biotechnology or pharmaceutical industries, including an in-depth knowledge and understanding of the regulatory environment. International regulatory experience required
• Knowledge of current US and EU regulations for oncology drugs, including experience preparing, filing, and performing life-cycle management of applications and all supportive amendments, supplements, and annual reports to the United States Food and Drug Administration (US-FDA) in eCTD format
• Knowledge of oncology global clinical trial regulations, including experience with submission of Clinical Trial Applications (CTAs) to global regulatory agencies and management of regulatory aspects of clinical trials in accordance with Good Clinical Practices (GCP) requirements
• Experience in submissions of Proposed Pediatric Study Request (PPSR), deferral requests, study protocols and clinical study reports (CSRs)
• Experience with health authority meeting preparation
• Proven ability to independently manage critical projects as part of an interdisciplinary team. In addition, the candidate should have experience preparing, managing and submitting major regulatory submissions.
• Ability to successfully manage multiple projects to deadlines
• Experience with regulatory intelligence activities and pharmaceutical registration databases to support product approval strategies

Equal Opportunity Employer Minorities/Women/Veterans/Disabled