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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 Respiratory, Immunology, and Inflammation assets, ensuring compliance throughout the product lifecycle while leading cross-functional teams and health authority interactions.
Highest-signal resume keywords
Regulatory Affairs ExperienceRegulatory Strategy DevelopmentHealth Authority InteractionsCross-Functional LeadershipClinical-Trial Requirements Knowledge
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 SubmissionsRegulatory ComplianceRegulatory IntelligenceDrug Development UnderstandingEvidence-Based StrategiesRisk Mitigation StrategiesLabeling ApproachesPharmaceutical DevelopmentLifecycle Management
Soft Skills
Influencing SkillsCommunication SkillsRelationship BuildingTeam LeadershipStrategic Thinking
Certifications & Qualifications
Bachelor's Degree in Biological ScienceMaster's Degree or PhD in Relevant Discipline
Industry Keywords
Respiratory MedicinesImmunology MedicinesInflammation MedicinesGlobal Regulatory EnvironmentMarketing Authorization RequirementsDue DiligenceBusiness DevelopmentClinical DevelopmentRegulatory Matrix TeamsGeographic Regulatory Activities
About the role
Key responsibilities & impact- Develop and execute innovative, evidence-based global and regional regulatory strategies for assigned Respiratory, Immunology and Inflammation assets
- Integrate regulatory strategy with medicines development plans, evidence-generation strategies and priority-market requirements
- Provide strategic regulatory leadership to cross-functional development teams
- Assess regulatory precedent, intelligence and competitive environments to identify opportunities, risks and development implications
- Translate complex scientific and regulatory information into clear recommendations
- Lead regulatory matrix teams and coordinate activities across functions and geographies
- Lead health-authority interactions, regulatory submissions, milestone meetings and review processes
- Partner with clinical development, safety, medical, commercial and local regulatory colleagues
- Develop regulatory approaches supporting appropriate labelling
- Anticipate regulatory risks and develop mitigation strategies
- Ensure compliance throughout the product lifecycle
- Represent regulatory perspectives with senior leaders and health authorities
- Contribute regulatory expertise to due-diligence and business-development activities
- Identify opportunities to use digital capabilities and new approaches to improve regulatory decision-making and efficiency
Requirements
What you’ll need- A bachelor’s degree or equivalent relevant professional experience in biological science, healthcare science or a related discipline
- Significant regulatory-affairs experience across pharmaceutical development and the product lifecycle
- Experience developing and delivering regulatory strategies for development programmes
- Experience leading regulatory submission and approval activities
- Track record of leading interactions or milestone meetings with health authorities
- Experience providing regulatory leadership within global, cross-functional matrix teams
- Strong knowledge of clinical-trial and marketing-authorisation requirements in major markets
- Sound understanding of the global regulatory environment
- Master’s degree, PhD or other advanced scientific or regulatory qualification advantageous
- Regulatory experience supporting Respiratory, Immunology and Inflammation medicines or development programmes advantageous
- Experience acting as a Global Regulatory Lead, Regional Regulatory Director or comparable strategic regulatory role advantageous
- Experience leading regulatory activities across multiple geographic regions advantageous
- Experience across development stages from early development through registration and lifecycle management advantageous
- Experience leading regulatory strategy with limited precedent or significant scientific complexity advantageous
- Strong influencing and communication skills advantageous
- Ability to build effective relationships and influence decisions without formal authority advantageous
- Commitment to quality, ethical conduct and compliance with applicable laws, regulations and company requirements
- Strong clinical and scientific understanding of drug development advantageous
- Experience applying regulatory intelligence, data or digital approaches to development and regulatory decision-making advantageous
- Experience providing regulatory input to due diligence, licensing or business-development evaluations advantageous
Benefits
Comp & perks- Annual bonus
- Eligibility to participate in a share based long term incentive program
- Health care and other insurance benefits for employee and family
- Retirement benefits
- Paid holidays
- Vacation
- Paid caregiver/parental and medical leave
- Hybrid working model with flexibility to work from the office and remotely
- Agile working culture
- Adjustments to the recruitment process where needed