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Associate Director / Director Regulatory Affairs

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

Real Staffing is looking for an Associate Director / Director, Regulatory Affairs to join Gilead Sciences in Seattle. This role will act as a global and US regulatory lead for investigational products and/or marketed products within the Oncology 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 an Associate Director / Director, Regulatory Affairs, you will manage a team of talented Regulatory professionals and be responsible for leading all regulatory activities in the Oncology program. This Associate Director / Director, Regulatory Affairs will take on the following initiatives:

  • Work with the project team and regional regulatory leads in the EU, Japan and other countries, 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
  • 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
  • Responsible for leading all regulatory activities for assigned projects in line with ICH requirements, regional requirements and scientific and company policies and procedures

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

  • Science degree in a related discipline (PhD, PharmD, MD, MSc)
  • Regulatory Affairs experience in a related therapeutic area working on small molecule projects (NDA submission experience is a plus)
  • 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.