Director, Regulatory Affairs, Oncology Early Development

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Job description

Company Description
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 immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok .

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 20 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 would be the Global Regulatory Lead where you will develop and implement global regulatory strategies to support the development of multiple oncology early development assets, contributingto the advancement of leading-edge cancer research in a nimble, biotech-like environment within a large, well established pharmaceutical company. 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 South San Francisco, CA location.

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 oncology 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 Health Authority meetings
• Manage and participate in the creation, review, assembly and submission of regulatory documentation including INDs and CTAs and amendments, RFIs, annual reports
• 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.

Qualifications

• Bachelors degree in the life sciences, chemistry, or related discipline. Advanced degree preferred.
• 8 12 years of experience in Regulatory Affairs (strong preference for experience in oncology) in the biotechnology or pharmaceutical industries, including an in-depth knowledge and understanding of the regulatory environment. International regulatory experience required.
• Demonstrated understanding of regulations and guidelines governing oncology drug development and ability to strategically apply to overall drug development
• Demonstrated leadership ability in team settings
• Strong written and verbal communication skills
• Demonstrate expertise and knowledge of oncology and relevant indications

Key Leadership Competencies:

• Builds strong relationships with peers and with partners cross functionally 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

Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible to participate in our short-term incentiveprograms.
• This job is eligible to participate in our long-term incentiveprograms

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.

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