Regulatory Affairs Associate II at Exelixis, Inc. in Alameda, California

Job Description:

Company Description

Every Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial.

As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult-to-treat cancers, we're seeking to add talented, dedicated employees to power our mission.

Cancer is our cause. Make it yours, too.

Position Description:

Responsible for managing and maintaining existing investigational new drug (IND) and clinical trial application (CTA) submissions and preparing amendments in compliance with guidelines and regulations. Coordinates, compiles, and tracks product applications to regulatory agencies.

Position Requirements:

ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Review clinical site regulatory documents to provide Regulatory approval to ship investigational product.
• Maintain study information and post results on ClinicalTrials.gov and EudraCT.
• Track safety reports and coordinate submissions to US INDs.
• Assist Project Team Regulatory Representative in preparing routine IND submissions and ex US clinical trial applications, tracking submission progress, and archiving regulatory submissions and correspondence.

SUPERVISORY RESPONSIBILITIES:
• None

EDUCATION/EXPERIENCE/SKILLS:
Education:
• AA degree in related discipline and a minimum of five year of related experience; or,
• BS/BA degree in related discipline and a minimum of three years of related experience; or,
• MS/MA degree in related discipline and a minimum of one year of related experience.
• Equivalent combination of education and experience.

Experience:
• Typically requires a minimum of six years of related experience and/or combination of experience and education/training in regulatory affairs.
• Knowledge of US and ex-US regulations and guidelines.

Knowledge/Skills/Abilities:
• Organizes and prioritizes numerous tasks and completes them under time constraints.
• Frequently applies technical standards, principles, theories, concepts and techniques.
• Performs a variety of complicated tasks with a wide degree of creativity and latitude.
• Determines methods and procedures on new assignments.
• Resolves a wide range of issues in creative ways.
• Experienced professional with a full understanding of area of specialization.
• Applies strong communication skills.
• Has good general knowledge of other related disciplines.

JOB COMPLEXITY:
• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
• Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
• Networks with senior internal and external personnel in area of expertise.

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DISCLAIMER

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.