Amgen
Regulatory Affairs Senior Director - Global Regulatory Leader - Oncology
United States - Remote · Director
Sponsorship not specifiedDetected 70 days ago
Product StrategyNegotiationFDA RegulatoryResearchLeadershipCommunicationRegulatory Affairs
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odds of building a lasting career here
38Risky
Cap-exempt (no lottery)0
Sponsors this role85
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
Thin sponsorship signal and lottery-bound. A low-probability bet with your clock running. Prioritize cap-exempt roles and proven entry-level sponsors first.
Lottery odds assume a STEM candidate.
Personalize to your clock →Employer immigration record
from this employer's Department of Labor filings
Green-card follow-through: 92%
Of 75 labor certifications old enough to have been used, 6 expired without the employer filing the next step. Median time from filing to decision: 486 days.100% of their filings were for a worker who already held the job.Only certifications past the 180-day window are counted — recent ones cannot have expired yet.
Files H-1B transfers
17 transfer filings in the last year, covering 17 workers. Median labor-condition decision: 7 days. An employer that already files transfers is one that can take over an existing H-1B.
Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.
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About the role
- Join Amgen's Mission of Serving Patients
- At Amgen, if you feel like you're part of something bigger, it's because you are.
- Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases.
Responsibilities
- To lead GRTs within Amgen's GRAAS organization
- Develop and execute global regulatory product strategies designed to achieve approval and target product labeling for prioritized assets in late development with highly complex development programs
- Independently develop the Global Regulatory Strategic Plan 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.
- Independently lead the planning and implementation of global regulatory filings (eg, clinical trial applications, marketing applications, label extensions)
- Ensure consistency of evidence-based global product communication (eg, regulatory submission documents)
- Assess regulatory mechanisms to optimize product development (eg, expediting FIH studies, Orphan Drug Designation, Fast Track Designation, conditional /accelerated approval, compassionate use, and pediatric plan) and ensure appropriate incorporation into the global regulatory strategy
- Lead GRTs and product teams in formal and informal communications with regulatory agencies
- Lead the approach and strategy for formal interactions with Regulatory agencies, especially those which could impact the global product strategy
Requirements
- Doctorate degree and 5 years of regulatory experience in biotech or science
- Master's degree and 9 years of regulatory experience in biotech or science
- Bachelor's degree and 11 years regulatory experience in biotech or science
- Your managerial experience may run concurrently with the required technical experience referenced above
Nice to have
- Contemporary oncology experience desired
- Previous experience leading a Regulatory team for submission and approval of an original marketing application and/or major new indication supplemental application
- Strong communication skills - both oral and written
- Ability to understand and communicate scientific/clinical information
- Ability to anticipate and mitigate against future strategic issues and uncertainties
- Cultural awareness and sensitivity to achieve global results
- Planning and organizing abilities
- Ability to make complex decisions and solve problems
Compensation
- 215,204.70USD -291,159.30 USD
Company info
- Career Category Regulatory Job Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are.
- If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team.
Equal opportunity
- 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.
- Please contact us to request accommodation.
- 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.
Visa & Work Authorization
- Sponsorship for this role is not guaranteed.
This listing is sourced directly from Amgen's careers page and normalized into a canonical job model.