Regulatory Affairs Director - Global Regulatory Lead
Location: Washington
Posted on: June 23, 2025
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Job Description:
Join Amgens Mission of Serving Patients At Amgen, if you feel
like youre part of something bigger, its because you are. Our
shared missionto serve patients living with serious illnessesdrives
all that we do. Since 1980, weve helped pioneer the world of
biotech in our fight against the worlds toughest diseases. With our
focus on four therapeutic areas Oncology, Inflammation, General
Medicine, and Rare Disease we reach millions of patients each year.
As a member of the Amgen team, youll help make a lasting impact on
the lives of patients as we research, manufacture, and deliver
innovative medicines to help people live longer, fuller happier
lives. Our award-winning culture is collaborative, innovative, and
science based. If you have a passion for challenges and the
opportunities that lay within them, youll thrive as part of the
Amgen team. Join us and transform the lives of patients while
transforming your career. Regulatory Affairs Director - Global
Regulatory Lead What you will do Lets do this. Lets change the
world. Amgen is seeking a Regulatory Affairs Director supporting
products in Obesity Therapeutic Area. Global Regulatory Affairs
(GRA) provides global regulatory leadership, expertise, and
execution for the development, registration, and life cycle
management of all Amgen molecules. In this vital, product-facing
role you will lead the Global Regulatory Team (GRT) in the
Regulatory Affairs organization. The role of the Regulatory Affairs
Director is to: Lead GRTs within Amgens GRAAS organization, Develop
a comprehensive regulatory strategy that takes into account
worldwide regulatory requirements to drive product development,
global registration, achievement and maintenance of desired
regional labeling, and effective regulatory agency interactions,
and Provide regulatory expertise and guidance to product teams. Key
Responsibilities: Develop and execute the global regulatory product
strategy Lead GRTs Represent Regulatory on the product team and
other key commercialization governance bodies Develop Global
Regulatory Strategic Plan and provide regulatory input into the
products Global Strategic Plan. Obtain input from the GRT members
to develop a global regulatory strategy which supports product
development, registration and lifecycle maintenance. Identify and
communicate regulatory risks Represent GRA on the product team
Develop registration strategies and plans aimed at achieving
regulatory approval and product labeling Provide regulatory
direction in the development of the core data sheet to align
commercial objectives in the context of available and expected
scientific data, regulatory guidance and precedent Lead the
planning and implementation of global regulatory filings (e.g.
clinical trial applications, marketing applications, label
extensions, CMC changes) Ensure consistency of evidence-based
global product communication (e.g. regulatory submission documents)
Monitor and assess impact of relevant global regulations, guidance,
and current regulatory environment Ensure guidance on regulatory
mechanisms to optimize product development (e.g. expediting FIH
studies, Orphan Drug, Fast Track, conditional /accelerated
approval, compassionate use and pediatric plan) is assessed and
incorporated into the global regulatory strategy Communicate
consistently well defined, successful regulatory strategies
throughout the organization such that expectation is understood
Ensure effective regulatory agency communications by leading core
regulatory and cross functional teams (e.g. GRTs, filing teams)
Attend key regulatory agency meetings which could impact the global
product strategy Represent Amgen Regulatory on external partnership
teams at the product level What we expect of you We are all
different, yet we all use our unique contributions to serve
patients. The dynamic professional we seek is a leader with these
qualifications. Basic Qualifications: Doctorate degree and 4 years
of regulatory experience in biotech or science Or Masters degree
and 7 years of regulatory experience in biotech or science Or
Bachelors degree and 9 years of regulatory experience in biotech or
science Preferred Qualifications: Ability to lead and build
effective teams Strong communication skills - both oral and written
Ability to understand and communicate scientific/clinical
information Ability to anticipate and mitigate against future
strategic issues & uncertainties Ability to resolve conflicts and
develop a course of action Cultural awareness and sensitivity to
achieve global results Planning and organizing abilities Able to
prioritize and manage multiple activities Ability to make complex
decisions and solve problems Ability to deal with ambiguity
Negotiation skills Global Regulatory Affairs experience Biological
product experience Early and late-stage development experience Due
Diligence experience What you can expect of us As we work to
develop treatments that take care of others, we also work to care
for your professional and personal growth and well-being. From our
competitive benefits to our collaborative culture, well support
your journey every step of the way. The expected annual salary
range for this role in the U.S. (excluding Puerto Rico) is posted.
Actual salary will vary based on several factors including but not
limited to, relevant skills, experience, and qualifications. In
addition to the base salary, Amgen offers a Total Rewards Plan,
based on eligibility, comprising of health and welfare plans for
staff and eligible dependents, financial plans with opportunities
to save towards retirement or other goals, work/life balance, and
career development opportunities that may include: A comprehensive
employee benefits package, including a Retirement and Savings Plan
with generous company contributions, group medical, dental and
vision coverage, life and disability insurance, and flexible
spending accounts A discretionary annual bonus program, or for
field sales representatives, a sales-based incentive plan
Stock-based long-term incentives Award-winning time-off plans
Flexible work models, including remote and hybrid work
arrangements, where possible Apply now for a career that defies
imagination Objects in your future are closer than they appear.
Join us. careers.amgen.com In any materials you submit, you may
redact or remove age-identifying information such as age, date of
birth, or dates of school attendance or graduation. You will not be
penalized for redacting or removing this information. Application
deadline Amgen does not have an application deadline for this
position; we will continue accepting applications until we receive
a sufficient number or select a candidate for the position. As an
organization dedicated to improving the quality of life for people
around the world, Amgen fosters an inclusive environment of
diverse, ethical, committed and highly accomplished people who
respect each other and live the Amgen values to continue advancing
science to serve patients. Together, we compete in the fight
against serious disease. Amgen is an Equal Opportunity employer and
will consider all qualified applicants for employment without
regard to race, color, religion, sex, sexual orientation, gender
identity, national origin, protected veteran status, disability
status, or any other basis protected by applicable law. We will
ensure that individuals with disabilities are provided reasonable
accommodation to participate in the job application or interview
process, to perform essential job functions, and to receive other
benefits and privileges of employment. Please contact us to request
accommodation. obesity
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