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 developing and executing global regulatory strategies, leading cross-functional teams, and ensuring compliance with regulatory requirements in the biotech industry. Proficient in communicating complex scientific information and navigating the regulatory landscape to achieve successful product approvals.
Highest-signal resume keywords
Global Regulatory Strategy DevelopmentRegulatory Filings ManagementTeam LeadershipRegulatory Risk AssessmentStrong Communication Skills
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 StrategyRegulatory FilingsClinical Trial ApplicationsProduct LabelingEvidence-Based CommunicationRegulatory Submission DocumentsRegulatory MechanismsGlobal Regulations MonitoringRegistration StrategiesCore Data Sheet Development
Soft Skills
Team BuildingConflict ResolutionPlanning and OrganizingDecision MakingCultural Awareness
Industry Keywords
BiotechRegulatory ExperienceGlobal Regulatory TeamsCommercialization GovernanceOrphan DrugFast TrackConditional ApprovalPediatric PlansRegulatory Agency CommunicationsGlobal Product Strategy
About the role
Key responsibilities & impact- Develop and execute the global regulatory product strategy
- Lead Global Regulatory Teams (GRTs)
- Represent Regulatory on the product team and key commercialization governance bodies
- Develop the Global Regulatory Strategic Plan and provide regulatory input into the product’s Global Strategic Plan
- Identify and communicate regulatory risks
- Develop registration strategies and plans for regulatory approval and product labeling
- Provide regulatory direction in development of the core data sheet
- Lead planning and implementation of global regulatory filings, including clinical trial applications, marketing applications, label extensions, and CMC changes
- Ensure consistency of evidence-based global product communication and regulatory submission documents
- Monitor and assess relevant global regulations, guidance, and the regulatory environment
- Assess and incorporate regulatory mechanisms such as FIH studies, Orphan Drug, Fast Track, conditional/accelerated approval, compassionate use, and pediatric plans
- Communicate regulatory strategies throughout the organization
- Lead core regulatory and cross-functional teams for effective regulatory agency communications
- Attend key regulatory agency meetings affecting global product strategy
- Represent Amgen Regulatory on external partnership teams at the product level
Requirements
What you’ll need- Doctorate degree and 4 years of regulatory experience in biotech or science
- Or Master’s degree and 7 years of regulatory experience in biotech or science
- Or Bachelor’s degree and 9 years of regulatory experience in biotech or science
- 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
Benefits
Comp & perks- 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
- Flexible spending accounts
- A discretionary annual bonus program
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible
- Career development opportunities
- Financial plans with opportunities to save towards retirement or other goals
- Work/life balance