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Senior Director / Executive Director, Regulatory Affairs

Location: Seattle, Washington Salary: competitive
Sector: Regulatory Affairs Type: Permanent

Real Staffing is looking for a Senior Director/Executive Director, Regulatory Affairs to join Gilead Sciences in the San Francisco Bay Area (Foster City) or Seattle (full relocation available for non-local candidates). This role will act as the global and US regulatory lead for investigational products and/or marketed products within the Inflammation therapeutic area. Discover more about the Regulatory team you'll be working alongside at https://regulatoryaffairs-careers.gilead.com/

About Gilead: 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, Gilead seeks 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.

The Role: As a Senior / Executive Director, Regulatory Affairs, you will manage a team of talented Regulatory professionals and be responsible for leading all regulatory activities in the Inflammation program. This Senior / Executive Director, Regulatory Affairs will take on the following initiatives:

  • 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
  • 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 sub-teams
  • Initiates or contributes to local and/or global process improvements which have a significant impact on business
  • Schedule and arrange own activities and those of direct reports

The best candidates for this role will have the following qualifications:

  • Science degree in a related discipline (PhD, PharmD, MD, MSc)
  • 12+ years of relevant experience in Regulatory Affairs, preferably including global regulatory experience managing investigational and marketed products
  • Must have 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
  • Excellent verbal and written communication skills and interpersonal skills
  • Work both independently and in a team environment

Salary: Negotiable + Bonus + Benefits + Full Relocation (if applicable)

If you are interested in hearing more about this opportunity, please apply with your updated resume ASAP, and I will reach out to you regarding interviews. Please feel free to contact me at 415-796-8017 to discuss the opportunity further.

Sthree US is acting as an Employment Agency in relation to this vacancy.