Director, Regulatory Affairs - Oncology Early Development

Company Description

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

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.

We are currently seeking a Regulatory Affairs Director to join our growing regulatory team. In this role you will be the Global Regulatory Lead where you will develop and implement global regulatory strategies to support the development of multiple oncology early development assets, contributing to the advancement of leading edge cancer research in a nimble, biotech –like environment within a large, well established pharmaceutical company.

The Director Regulatory Affairs Global Regulatory Lead in OED RA is responsible for developing and implementing global regulatory strategies to support the development of multiple oncology early development assets, contributing to the advancement of leading-edge cancer research in a nimble, biotech –like environment within a large, well established pharmaceutical company.

The GRL leads the Global Regulatory Product Team (GRPT). Project responsibilities may include Area Lead (US/Canada) role. May lead the Labeling Regulatory Strategy Team (LRST). Ensures strategic messaging in global regulatory dossiers and responses under guidance of management. Serves as the primary regulatory interface with the AST and supporting teams. Ensures compliance with global regulatory requirements. Demonstrates strong understanding of drug development and leadership behaviors consistent with level. Develop and implement acceleration strategies with guidance from supervisor.

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.

Key Responsibilities:

· Serve as the Global Regulatory Lead on project teams and key sub-teams

· Develop and implement competitive and effective global regulatory strategies for several products including clinical, nonclinical and CMC aspects and identify potential risks associated with proposed strategies

· Provide advice and guidance to 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 and governance meetings

· Serve as primary Health Authority contact for assigned projects and foster positive and effective working relationships between project team members and Health Authority reviewers

· Prepare teams for and lead FDA and other Health 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 assigned such as department initiatives, business development assessments, clinical assessments and department training, etc.

Qualifications

· Re