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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in developing and executing regulatory strategies for oncology assets, ensuring compliance with global and regional requirements while fostering collaboration across cross-functional teams. Proficient in managing submissions and approvals, with a strong focus on process improvement and innovative solutions within regulatory frameworks.
Highest-signal resume keywords
Regulatory AffairsOncology ExperienceClinical Trial RequirementsRegulatory StrategiesStakeholder Management
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 ComplianceDrug Development ProcessSubmission ActivitiesLabeling ApprovalsRegulatory Intelligence
Soft Skills
CollaborationProblem SolvingCommunicationMatrix LeadershipBusiness Resilience
Tools & Technologies
Digital Fluency Tools
Certifications & Qualifications
Advanced Scientific Degree (PhD, MD, PharmD)
Industry Keywords
OncologyRegulatory StrategiesMedicines Development StrategyIntegrated Asset PlanProduct Lifecycle
About the role
Key responsibilities & impact- Develop and execute global and regional regulatory strategies for oncology assets
- Ensure optimal labeling and approvals while maintaining compliance with internal and external requirements
- Collaborate with the Global Regulatory Lead, Global Regulatory Therapeutic Area Head, global/regional counterparts, local operating companies, and cross-functional teams
- Shape development plans and regulatory interactions across multiple regions
- Develop and deliver regulatory strategies meeting key market requirements
- Align regulatory plans with Medicines Development Strategy and Integrated Asset Plan
- Support interactions, reviews, and submissions with regional/local regulatory authorities for product development and approval
- Assess regulatory intelligence, precedents, and competitive landscape to inform strategy and improve decision-making
- Ensure compliance with global, regional, and local regulatory requirements throughout the product lifecycle
- Drive process improvement, innovation, and performance excellence through strategic changes
Requirements
What you’ll need- Bachelor’s degree in biological, pharmaceutical or healthcare science
- 1+ year of experience in drug development process, preferably in regulatory affairs and oncology
- 1+ years of experience in clinical trial requirements in at least one major regional/global market
- Advanced scientific degree (PhD, MD, PharmD) preferred
- Proven ability in managing global and regional development, submission, and approval activities preferred
- Demonstrated ability to foster collaborative environments, proactively resolve challenges, and develop innovative solutions within regulatory constraints preferred
- Proficiency in digital fluency tools preferred
- Strong written and verbal communication skills preferred
- Experience working effectively in matrix teams preferred
- Experience working in oncology preferred
- Skills in business resilience, communication, digital fluency, matrix leadership, pharmaceutical regulatory compliance, regulatory strategies, resource management, and stakeholder management
Benefits
Comp & perks- Competitive salary
- Annual bonus based on company performance
- Healthcare and wellbeing programs
- Pension plan membership
- Shares and savings programme
- Hybrid working model with remote and in-office work
- Annual bonus
- Share-based long-term incentive program eligibility
- Health care and other insurance benefits for employee and family
- Retirement benefits
- Paid holidays
- Vacation
- Paid caregiver/parental and medical leave