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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 leading global regulatory strategies for pharmaceutical and biological products, with a strong focus on collaboration across cross-functional teams and health authorities. Possesses advanced knowledge of regulatory requirements and the ability to influence stakeholders while driving accountability and fostering talent.
Highest-signal resume keywords
Global Regulatory Affairs StrategyRegulatory Requirements KnowledgeLeadership ExperienceCross-Functional CollaborationStrategic Thinking
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 Strategy DevelopmentPharmaceutical Product DevelopmentRegulatory IntelligenceClinical Development ExpertiseRegulatory SubmissionsHealth Authority InteractionsOrphan Drug DesignationsPediatric Study PlansBusiness AnalyticsAI-Enabled Insights
Soft Skills
Excellent CommunicationInfluencing SkillsRelationship BuildingSound JudgmentCollaboration
Certifications & Qualifications
Bachelor's Degree in PharmacyBachelor's Degree in BiologyBachelor's Degree in ChemistryBachelor's Degree in PharmacologyBachelor's Degree in Clinical MedicineAdvanced Degree (MS, PhD, MD, DVM)MBA
Industry Keywords
BiotechnologyPharmaceutical IndustryRegulatory AffairsFDAEMAGlobal MarketsMatrixed OrganizationsPatient-Focused MindsetInnovative TherapiesComplex Regulatory Decisions
About the role
Key responsibilities & impact- Develop and lead integrated, science-based global regulatory strategies for assigned products across development, registration, and post-marketing activities
- Serve as the primary Global Regulatory Affairs representative on Product Strategy Teams and cross-functional development teams
- Partner with Clinical Development, Safety, Commercial, Research, and other stakeholders to integrate regulatory considerations into product strategy and decisions
- Lead strategic relationships and interactions with key health authorities, including the FDA and EMA
- Collaborate with regional regulatory partners to support successful regulatory outcomes across global markets
- Lead the Global Regulatory Affairs Strategy Team for assigned products
- Establish priorities, coordinate deliverables, assign responsibilities, and ensure alignment across global regulatory functions
- Review and, where appropriate, approve key development deliverables, including protocols, Target Product Profiles, and strategic documents
- Provide regulatory guidance to senior leadership and cross-functional teams
- Oversee Core Briefing Books, Orphan Drug Designations, Pediatric Study Plans, and Global Regulatory Strategy Outlines
- Use competitive regulatory intelligence, emerging technologies, AI-enabled insights, business analytics, and specialized regulatory expertise to inform strategy
- Build relationships across Global Regulatory Strategy, regional regulatory teams, and Regulatory CMC
- Coach and develop Regional Regulatory Leads where applicable
- Establish performance expectations, foster accountability, support succession planning, and support career growth
- Demonstrate CSL leadership capabilities by building partnerships, thinking strategically, driving outcomes, embracing agility, inspiring innovation, and cultivating talent
Requirements
What you’ll need- Bachelor's degree in Pharmacy, Biology, Chemistry, Pharmacology, Clinical Medicine, or a related life science discipline required
- Minimum of 10 years of experience in the biotechnology or pharmaceutical industry
- At least 8 years in Regulatory Affairs
- At least 5 years of experience supporting pharmaceutical or biological product development
- Demonstrated experience leading teams, preferably with 5 years of direct or matrix leadership experience
- Strong knowledge of pharmaceutical and biological product development and regulatory requirements across multiple major regions, including the US, EU, and/or Japan
- Demonstrated experience working directly with at least one major health authority, such as the FDA or EMA
- Experience navigating complex, global, matrixed organizations and influencing cross-functional stakeholders
- Strong clinical development or medical device expertise is highly desirable
- Advanced degree (MS, PhD, MD, DVM) or MBA preferred
- Strong strategic thinking and ability to translate complex regulatory considerations into actionable development strategies
- Excellent communication, influencing, and relationship-building skills
- Sound judgment and confidence in making complex regulatory decisions and taking calculated risks
- Ability to lead through influence, foster collaboration, and drive accountability across geographically dispersed teams
- Patient-focused mindset and passion for advancing innovative therapies through successful development and approval
Benefits
Comp & perks- Incentive compensation
- Equity
- Reasonable accommodation for individuals with disabilities during the application process
- Inclusion and belonging initiatives
- Opportunity to work on innovative therapies that address unmet medical needs