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Gilead

Senior Director, Regulatory Affairs - HIV

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 founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

The Senior Director will be the Global Regulatory Lead for investigational HIV products and oversee the global and US regulatory activities for marketed and investigational products. Working with the project team and Regional Regulatory Leads in the EU, Japan and other countries, the Senior Director will develop global clinical and nonclinical 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 Senior Director will represent regulatory affairs on cross-functional project teams, clinical and other sub teams, and will provide strategic leadership for the regulatory project team and regulatory submission team with international participants. The Senior Director will supervise and mentor other regulatory professionals on product related topics and regulatory process-related topics.  Requires the ability to work both independently and in a team environment.
 

Key Responsibilities:

  • Lead all regulatory activities for assigned projects in line with ICH requirements, regional requirements and scientific and company policies and procedures
  • Contribute to the development of global clinical and nonclinical regulatory plans and strategies;  identifies and proposes risk mitigation strategies; and influences project teams and sub teams
  • Prepare and/or manage submissions that are technically complex and require extensive interaction with departments outside of regulatory affairs
  • Ensure up-to-date knowledge of highly complex regulatory requirements, comment on draft regulatory guidance and communicates changes in regulatory information to project teams and senior management
  • Initiate or contribute to local and/or global process improvements which have a significant impact on the business

Minimum Qualifications:

  • Science degree (PhD, PharmD, MD, MSc) with a minimum of 12+ years of experience in regulatory affairs or other relevant industry experience, and preferably including experience as global regulatory lead managing investigational and marketed products
  • Demonstrated effective verbal and written communication, negotiation and interpersonal skills
  • Extensive knowledge of regulatory requirements, including ICH requirements and regional requirements for assigned territories and have an understanding of current global and regional trends in regulatory affairs and ability to assess the impact of these requirements on the business
  • Proven capability with developing and implementing regulatory strategies and managing complex negotiations with regulatory authorities
  • Experience with taking a leadership role in updating and preparing the company for major changes in legislation in assigned territories which impact many departments
  • Demonstrated ability to critically review complex technical documents and influence colleagues across functions
  • Experience leading one or more teams in preparation of submissions and maintenance of licenses

Meet the team:

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


For jobs in the United States:

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.

For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ poster.

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PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

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.

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