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.
Required education: Bachelor degree in life sciences, chemistry, or related discipline.
Preferred Education: Relevant Advanced degree preferred. Certification a plus.
5+ years of experience in Regulatory Affairs (strong preference for experience in oncology and/or cell and gene therapy) in the biotechnology or pharmaceutical industries, including an in-depth knowledge and understanding of the regulatory environment. International regulatory experience required. Some portion may include relevant exposure to pharmaceutical regulatory work (e.g., other R&D role or specialized training).
Proven success in a strategic leadership role with strong project management skills. Experience working in a complex and matrix environment, and with multiple stakeholders. Demonstrated leadership ability in team settings
Experience interfacing with government regulatory agencies.
Demonstrated understanding of regulations and guidelines governing drug development and ability to apply these to overall strategic drug development
Strong written and verbal communication and negotiation skills
Demonstrated Business acumen and able to work under pressure
Demonstrated expertise
Benefits
Health insurance
Additional Information
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.
Abbvie · South San Francisco, CA