Regulatory Affairs Manager, 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 Twitter , Facebook , Instagram , YouTube and LinkedIn .

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.

AbbVie is focused on the discovery and development of novel oncology therapies. This role is based in the San Francisco Bay Area.

We are currently seeking a Regulatory Affairs Manager to join our growing regulatory team. In this role you would be supporting multiple Global Regulatory projects, contributing to the advancement of leading-edge cancer research as part of a nimble, biotech-like environment within a large, well established pharmaceutical company.

Key Responsibilities:

• Support multiple Global Regulatory project teams and key sub-teams; provide functional expertise to GRLs and matrix early development teams.
• Collaborate with AbbVie regional and country regulatory affiliates to support ex-US clinical development activities.
• Provide support to prepare for presentations of Regulatory strategies and issues at team or governance meetings.
• Serve as primary Health Authority contact for assigned projects and foster positive and effective working relationships between project team members and regulatory authority reviewers.
• Assist in preparing teams and materials for FDA (or other regulatory authority) meetings.
• Participate in or lead 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 or lead non-program specific projects as assigned such as department initiatives, business development assessments, clinical assessments, and department training, etc.

Qualifications

Qualifications:

• Bachelors degree or equivalent required in related discipline.
• 5+ years of experience in biotechnology or pharmaceutical industry, including R&D/related disciplines.
• 3-4 + years of experience in Regulatory Affairs within biotechnology/pharmaceutical industry.
• Demonstrated understanding of regulations and guidelines governing drug development; has relevant knowledge and experience in applying these to strategic drug development
• Perceived as a subject matter expert by internal colleagues.
• Effective interfacing with regulators; has experience working with Health Authorities.
• Works effectively in complex, matrix organizations; drives outcomes and recommendations for action/consideration.
• Strong written and verbal communication skills.
• Demonstrate expertise and knowledge of oncology and relevant indications.
• Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.
• Learns fast, grasps the 'essence' and can change the course quickly where possible.
• Raises the bar and is never satisfied with the status-quo.
• Creates a learning environment, open to suggestions and experimentation for improvement.
• Embraces the ideas of others, fosters innovation, and recommends new ideas.

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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