Gilead Sciences, Inc. Director, Regulatory Affairs in Seattle, Washington

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Description

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions. Within the Gilead family, Kite Pharma are a leader in engineered T cell therapy, changing the paradigm of cancer treatment with what is potentially the biggest breakthrough since the introduction of combination therapy. With an unrelenting drive and a singular focus on our strategy to bring life-saving therapies to patients.

Meet the team:

https://regulatoryaffairs-careers.gilead.com/

The Director, will be the global and/or US regulatory lead for investigational products and/or marketed products. The Director working with the project team and regional regulatory leads in the EU, Japan and other countries, will develop global regulatory strategies, provide regulatory guidance, critically review documents for submission to regulatory authorities, and oversee the execution of the global regulatory strategy by the regions in line with the project team’s goals for each of the products. The Director will represent regulatory affairs on cross-functional project teams, clinical and commercial subteams, and will provide strategic leadership to the regulatory project team and regulatory submission team with international participants. The Director will supervise and mentor other regulatory professionals on product related topics and regulatory process-related topics. Requires ability to work both independently and in a team environment.

Specific Responsibilities and skills for Position

• Responsible for leading all regulatory activities for assigned projects in line with ICH requirements, regional requirements and scientific and company policies and procedures.

• Contributes to the development of global clinical and regulatory plans and strategies, identifies and proposes risk mitigation strategies, and influences project teams and subteams.

• Prepares and/or manages submissions that are technically complex and require extensive interaction with departments outside of regulatory affairs.

• Maintains knowledge of highly complex regulatory requirements up to current date, contributes to preparation of new regulatory guidance wherever possible, comments on draft regulatory guidance and communicates changes in regulatory information to project teams and senior management.

• Initiates or contributes to local and/or global process improvements which have a significant impact on business.

• Excellent verbal, written, negotiation, influence and interpersonal communication skills are required.

• Must have an extensive knowledge of regulatory requirements, including ICH requirements and regional requirements and have an understanding of current global and regional trends in regulatory affairs and ability to assess the impact of these requirements to the business.

• Must be capable of developing and implementing regulatory strategies and of managing complex negotiations with regulatory authorities.

• Must be capable of taking a leadership role in updating and preparing the Company for major changes in legislation which impact many departments.

• Must be capable of critically reviewing complex technical documents and influencing colleagues across functions.

• Must be capable of effectively leading teams in preparation of submissions.

• Schedules and arranges own activities and those of direct reports.

• Is recognized as an expert resource for regulatory advice across departments.

Knowledge, Experience and Skills

The ideal candidate for this position should have a science degree (PhD, PharmD, MD, MSc) with 12+ years of overall regulatory experience, and preferably including experience as global regulatory lead managing investigational and marketed products. The candidate should have demonstrated leadership and organizational skills.

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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

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Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community at http://gilead.avature.net/Gilead