Regulatory Affairs Director - Oncology
Regulatory Affairs Director - Oncology
United States - Remote Apply NowHOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.
Regulatory Affairs Director - Global Regulatory Leader - Oncology
Live
What you will do
Let’s do this. Let’s change the world. Amgen is seeking a Regulatory Affairs Director supporting products in the Oncology 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 purpose of Regulatory Affairs Director is:
To lead a team within Amgen’s Global Regulatory Affairs department
To 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
To provide regulatory expertise and guidance to product teams
Key Responsibilities include:
Develop and execute the global regulatory product strategy
Lead Global Regulatory Teams
Represent Global Regulatory Affairs on the Product Team and key commercialization governance bodies
Develop Global Regulatory Strategic Plans and provide regulatory input into the product's 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 direction in the development of the core datasheets 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 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
Win
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
Master’s degree and 8 years of regulatory experience in biotech or science, OR
Bachelor’s degree and 10 years of regulatory experience in biotech or science
Preferred Qualifications:
Contemporary oncology experience desired
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
Organizational savvy
Negotiation skills
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
Amgen offers a Total Rewards Plan comprising 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 including:
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 and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible
Apply now for a career that defies imagination
Objects in your future are closer than they appear. Join us.
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
careers.amgen.com
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. 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.
