Director, Regulatory Affairs
Company: Gilead Sciences, Inc.
Location: San Mateo
Posted on: January 25, 2023
Director, Regulatory Affairs
United States - California - Foster CityUnited States - New Jersey
- Morris PlainsUnited States - Washington - Seattle
Gilead Sciences, Inc. is a research-based bio-pharmaceutical
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
Making an impact on a global scale
Inclusion is one of the company's five core values. That's because
we know that we are stronger and more innovative at Gilead when we
are informed by a diverse set of backgrounds, experiences and
points of view. Gilead Sciences is a biopharmaceutical company that
discovers, develops and commercializes innovative therapeutics in
areas of unmet medical need. The company's mission is to advance
the care of patients suffering from life-threatening diseases
When you join Gilead, you join our mission to change the world by
enabling people to live healthier and more fulfilling lives. Come
join a mission-driven bio-pharmaceutical organization that values
inclusion and diversity, has a strong portfolio of products, and is
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this
At Gilead we believe every employee deserves a great leader. As a
people leader now or in the future, we expect that you will model
and create an environment of inclusion, be intentionally focused on
the hiring, development, growth and retention of talent, and
empower teams to align and achieve goals.
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 Create Possible and
improve the care of patients living with life-threatening diseases
around the world. Gilead's therapeutic areas of focus include
Virology, Oncology and Inflammatory Diseases. Our portfolio of more
than 25 marketed products includes innovative complete treatment
regimens for chronic hepatitis C infection, chronic hepatitis B
infection and HIV in once-daily single pills in our Virology
portfolio. Our Oncology portfolio includes an antibody-drug
conjugate for the treatment of certain patients with unresectable
locally advanced or metastatic triple-negative breast or locally
advanced or metastatic urothelial cancers, and two CAR T therapies
approved for the treatment of adult patients with certain B cell
lymphomas or Mantle Cell Lymphoma. Since its founding in Foster
City, California, in 1987, Gilead has become a leading
biopharmaceutical company with a rapidly expanding product
portfolio, an impressive pipeline of investigational drugs across
therapeutic areas, and over 14,000 employees in offices across six
continents. Millions of people around the world are living
healthier lives because of innovative therapies developed by
Gilead. Today, our innovative approach to external partnerships,
and our internal research and development effort include hundreds
of ongoing and planned clinical studies evaluating compounds with
the potential to become the next generation of effective
Meet Some Gilead Employees:
Gilead has established employee resource groups to support
diversity and inclusion and provides a competitive benefit package
including flexible work options and exceptional support for the
family and the individual.
Would you like to play a crucial role in developing life-saving
therapies? Are you excited to use your scientific insight to
partner with internal teams and external partners as we strive to
cure unmet medical needs?
We have an exciting and unique opportunity for a senior Regulatory
Professional to join our dynamic team at the Director level. You
will lead a regulatory team in the development and execution of the
global regulatory strategy for our HBV Cure program. This will be
accomplished by you developing, communication and leading the
global regulatory strategy across various cross functional teams,
leading the regulatory project team, collating regional
strategies/input, and articulating global regulatory strategy in
The Director will be site based at one of our locations in the US
including Foster City, CA; Seattle, WA or Morris Planes, NJ.
following our G Flex program that allows for up to three days work
from home as appropriate and will report to the Executive Director,
- Accountable for the successful oversight and completion of a
broad spectrum of regulatory activities and deliverables for
typically a portfolio of products, compounds, indications and/or
other projects in the virology therapeutic area.
- Specifically, accountable and responsible for the development
and execution of the global HBV Cure regulatory strategy through
leadership and oversight of global regulatory team which includes
global and regional regulatory liaisons, product labeling leads,
medical writers, advertising and promotion leads, project managers
and regulatory operations publishing leads.
- Responsible for leading all regulatory activities for assigned
project(s) and territories in line with ICH requirements, regional
requirements and scientific and company policies and
- Responsible for development, oversight and communication of
global and regional (as applicable) regulatory strategy for
assigned projects and regions.
- Provides matrix management and leadership to multiple or
larger-scale projects and teams.
- Oversees contacts for local Regulatory Authorities.
- Advises other functions on short- and long-range regulatory
strategies, plans, resources and tactics in cross functional
meetings as the global regulatory representative such as the
program strategy team and global development team.
- Works on extremely complex problems and provides solutions that
have significant impact.
- Influences the long-term strategy of the virology therapeutic
- May have one or more direct reports. May lead other people
- May participate in and play a more active role in Virology
therapeutic area Regulatory short- and long-range budget and
resource plan development and management.
- Typically plays a lead role in special projects, such as
continuous improvement and optimization initiatives with potential
impact across Global Regulatory Affairs.
- Serves as a spokesperson for Regulatory Affairs on significant
matters relating to policies, programs, capabilities, and long-term
goals and objectives.
- Recognized as a key representative for the conduct and
oversight of regulatory activities for a broad portfolio of
products and/or projects.
- Represents Gilead at external professional meetings or
discussions with industry trade groups.
How We Expect you to Work:
- Routinely advises other colleagues on ways to better
demonstrate and uphold our Leadership Commitments and Values.
- Able to extract added value and improved results by increasing
standards and expectations across projects and teams.
- Independently determines how to structure and approach complex
and often large-scale projects and other work to ensure strategic
objectives are met or exceeded within the targeted timelines and
- Looks for ways to put the least pressure on resources to
achieve the targeted results.
- Able to effectively represent complex and often high-profile
projects to senior leaders and executives.
- Adept at distilling complex matters into a clear and elevating
business case and roadmap for execution.
- Plays a lead role in significant change efforts as part of the
complex projects or other work managed.
- Plays the lead role in advising project and business leaders on
how to proactively incorporate change management into large-scale
projects and initiatives to ensure ultimate success.
- Works effectively across a broader and more senior set of
- Models effective stakeholder management for other team members
- Ensures other team members adopt and maintain proactive and
strong stakeholder management for the overall success of their
- Identifies, recommends and may lead strategic efforts to
innovate or otherwise significantly improve outcomes for complex
projects or other work.
Education, Knowledge and Other Experience:
- 12+ years of experience in Regulatory Affairs or other relevant
industry experience with BS/BA
- 10+ years of experience in Regulatory Affairs or other relevant
industry experience with MA/MS/MBA
- 8+ years of experience in Regulatory Affairs or other relevant
industry experience with PharmD/PhDBA/BS or advanced degree in life
sciences or related field is preferred with extensive experience in
the biopharma industry, including extensive experience working in
regulatory or a related discipline. Significant experience setting
the regulatory strategy and leading a broad range of regulatory
activities for biopharmaceutical products including:
- Excellent verbal, written . click apply for full job
Keywords: Gilead Sciences, Inc., San Mateo , Director, Regulatory Affairs, Executive , San Mateo, California
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