Senior Director, Global Regulatory Strategy Leader - Oncology Programs

Location
Foster City, California
Salary
We offer a competitive salary and benefits package.
Posted
May 27, 2021
Closes
Jun 27, 2021
Education
BS
Hours
Full Time

We want the revolutionaries, the committed collaborators, the bold challengers, the I-can-do-it-ers. Because those are the kind of people who are best able to make an impact for people with cancer. So, what’s missing? Just someone like you.

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.

The Regulatory Affairs organization at Gilead has an exciting and highly impactful opportunity available for a Senior Director to build the Oncology portfolio at Gilead.  This strategic leader will report into the VP of Regulatory Affairs and will guide and develop a team of regulatory strategists that are shaping the early and growing phases of Oncology at Gilead.

Key Responsibilities:

  • Responsible for development, oversight and communication of global regulatory strategy for assigned projects

  • Serves as a Core member of the cross-functional Project Team representing the global regulatory strategy for assigned global multi-indication projects

  • Leads Regulatory Project Team for assigned projects

  • Leads or manages leads of cross-functional/cross-regional Regulatory Submission Teams and participates on other sub teams.  Oversees submissions that are technically complex and require extensive interaction with departments outside of Regulatory Affairs.

  • Accountable for leading all regulatory activities for assigned project(s) and territories in line with ICH requirements, regional requirements and scientific and company policies and procedures

  • Responsible for ensuring responsibilities of Applicant and/or License Holder defined in legislation and regulatory guidance is met for assigned product(s) and territories

  • Accountable for preparation and maintenance of country specific labeling and product packaging (region specific) and ensuring alignment with relevant global Regulatory strategy

  • Ensures up-to-date knowledge of highly complex regulatory requirements, contributes to preparation of new regulatory guidance, comments on draft regulatory guidance, and communicates changes in regulatory information to project teams and senior management

  • Initiates or contributes to process improvements which have a significant impact on the business. Leader in Regulatory Affairs department leadership initiatives. 

  • People manager for regulatory liaisons involved in development and workload management

 

Minimum Qualifications:

  • Bachelors Degree with 15+ years of progressively responsible Regulatory Affairs experience within pharma/biotech industry to include Market Applications Submission experience (BLA/NDA/MAA) and experience developing and implementing regulatory strategy and managing complex negotiations with Regulatory Authorities

  • Demonstrated effective verbal, written, negotiation and interpersonal communication skills are required

  • 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 to the business

  • Proven track record with taking a leadership role in updating and preparing the Company for major changes in legislation in assigned territories, which impact many departments

  • Prior experience leading one or more teams in preparation of submissions and maintenance of licenses

  • Recognized as an expert resource for Regulatory Advice in other departments

Preferred Qualifications:

  • Oncology filing experience including original BLA/NDA

  • Global filing experience

 

We offer a competitive salary and benefits package.  Apply today at Gilead and Kite | Jobs and Careers (yello.co)