Regulatory Affairs Manager 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.

Job Description

This role manages US investigational new drug applications (IND), ex-US clinical trial applications, and related correspondence from the US Food and Drug Administration (FDA) and other regulatory authorities.

Qualifications

ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Manages the preparation, submission and maintenance of US Regulatory applications, including routine amendments, annual reports, and correspondence to FDA and other regulatory authorities.
• Works with external vendors and internal subject matter experts to plan, prepare, submit, and maintain CTAs in Europe, Asia, and other regions.
• Evaluates documents submitted to Regulatory Agencies to assure that they are complete, organized, of high quality, and compliant with applicable regulations.
• Maintains Investigational New Drug (INDs) and New Drug Applications (NDAs); prepares and reviews annual reports, site initiation packages, drug shipment approvals, safety reports, etc.
• Maintains study information on Clinical Trials.gov.
• Represent Regulatory Affairs in multi-disciplinary study teams.
• Liaise internally with members of the company's functional departments and externally with vendors.

SUPERVISORY RESPONSIBILITIES:
• None

EDUCATION/EXPERIENCE/SKILLS:

Education:
• BS/BA degree in related discipline and seven years of related experience; or,
• MS/MA degree in related discipline and five years of related experience; or,
• Equivalent combination of education and experience.
• May require certification in assigned area.

Experience:
• Typically requires a minimum of ten years of related experience and/or combination of experience and education/training.
• Minimum of five years overall experience in the biopharmaceutical/biotech industry and at least three years of direct experience in a Regulatory Affairs function
• Relevant working experience with the FDA Center for Drug Evaluation and Research (CDER), or equivalent experience with similar ex-US regulatory authorities.
• Typically requires a minimum of ten years of related experience and/or combination of experience and education/training.
• Experience in Biotech/Pharmaceutical industry preferred.

Knowledge/Skills/Abilities:
• Has extensive experience in relevant industry/profession and area of specialization.
• Uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
• Identifies and implements methods and procedures to achieve results.
• Leads or manages the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.
• Performs a variety of complicated tasks with a wide degree of creativity and latitude.
• Has complete understanding and wide application of technical principles, theories, concepts and techniques.
• Has good general knowledge of other related disciplines.
• Applies strong analytical and business communication skills.

JOB COMPLEXITY:
• Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
• Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation of criteria for obtaining results.
• Uses professional concepts and company's policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.
• Networks with key contacts outside own area of expertise.

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Additional Information

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.