FREE ACCESS
5,000–10,000 jobs/day
See all jobs on Scoutfield
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Regulatory Affairs with a focus on IND development, regulatory submissions, and compliance with local and corporate standards. Possesses strong organizational skills and the ability to manage interactions with regulatory agencies effectively.
Highest-signal resume keywords
Regulatory Affairs ExperienceIND DevelopmentRegulatory SubmissionsRegulatory ComplianceRegulatory Strategy
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory SubmissionsIND DevelopmentRegulatory ComplianceLabel DevelopmentRegulatory Documentation
Soft Skills
Organizational SkillsDetail OrientedAdaptability
Industry Keywords
Regulated IndustryLife ScienceHealth ScienceRegulatory AgenciesClinical Practice
About the role
Key responsibilities & impact- Support the Global Regulatory Team in US Regulatory Activities, including IND development and submission
- Act as the point of contact with regulatory agencies
- Provide guidance on local mechanisms to optimize product development and regulatory approvals
- Plan and manage local regulatory submissions in compliance with corporate standards and local regulatory requirements
- Ensure and support local regulatory product compliance, including agency commitments
- Develop and maintain local labels in line with local legislation and Amgen standards and procedures
- Support and provide input into global regulatory strategy for assigned products, including Global Regulatory Plans and labeling documents
- Prepare supportive documentation for regulatory deliverables, such as regulatory landscapes or research for regulatory strategy and target product labels
- Manage the process for responding to regulatory agency questions
- Provide primary authorship to routine regulatory correspondence
- Work with federal, state, and local regulatory agencies on issues and regulations affecting Amgen’s products and services
Requirements
What you’ll need- Doctorate degree OR Master’s degree and 2 years of Regulatory Affairs experience OR Bachelor’s degree and 4 years of Regulatory Affairs experience OR Associates degree and 8 years of Regulatory Affairs experience OR High school diploma / GED and 10 years of Regulatory Affairs experience
- Master’s degree in a biology, life science, health science curriculum, or regulatory science with biology curriculum
- Regulated industry, science or clinical practice experience
- Organizational skills; detail oriented and able to deal with frequent changes in product activity
Benefits
Comp & perks- A comprehensive employee benefits package
- Retirement and Savings Plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- Discretionary annual bonus program
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible
- Career development opportunities
- Work/life balance
- Financial plans with opportunities to save towards retirement or other goals