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Associate Director, Global Regulatory Strategy
Telix Pharmaceuticals Limited. Lead regulatory activities for clinical and commercial registrations across global markets .
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 clinical and commercial submissions, including INDs, NDAs, and MAAs. Proven ability to lead regulatory strategies and manage cross-functional teams while ensuring compliance with global regulatory frameworks.
Highest-signal resume keywords
Regulatory Affairs LeadershipClinical And Commercial SubmissionsGlobal Regulatory FrameworksICH Guidelines KnowledgeRegulatory Risk Assessment
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Regulatory Strategy DevelopmentIND SubmissionsNDA SubmissionsMAA SubmissionsCTD/eCTD SubmissionsLifecycle ManagementRegulatory Portfolio ManagementHealth Authority InteractionsRegulatory CompliancePost-Market Variations
Soft Skills
Effective CommunicationTeam CollaborationAdaptabilityEthical BehaviorContinuous Professional Development
Industry Keywords
Life SciencesPharmacyRegulatory AffairsFDAEMATGAPMDAHealth CanadaMedsafeQuality Assurance
About the role
Key responsibilities & impact- Lead regulatory activities for clinical and commercial registrations across global markets
- Manage the PSMA franchise regulatory portfolio, including new product development, registration approvals, and lifecycle management
- Develop and implement regulatory strategies for clinical, commercial, and lifecycle-management submissions
- Plan submissions for INDs, NDAs, MAAs, and other relevant regulatory filings with cross-functional teams
- Manage the PSMA portfolio team, including workload distribution and timeline adherence
- Lead registration strategies and registration processes for the PSMA franchise
- Act as regulatory lead for the PSMA portfolio, aligning activities with global regulatory frameworks
- Provide regulatory risk assessments and mitigation plans
- Prepare and present strategies to regulatory authorities and communicate with applicants and health authorities
- Collaborate with QA, Clinical Development, Research and Innovation, Commercial, Supply Chain, Quality, and Strategic teams
- Lead regulatory portfolio planning and prioritization
- Advise senior management on regulatory risks and opportunities
- Manage responses to Health Authority queries, variations, and post-market compliance requirements
- Support the Senior Director, Global Regulatory Strategy, with global regulatory projects and strategic initiatives
Requirements
What you’ll need- Degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field (advanced degree preferred)
- 9+ years of experience in Regulatory Affairs, including leadership
- Strong experience in clinical and commercial regulatory submissions, including CTAs, INDs, NDAs, MAAs, and post-market variations
- Expertise in global regulatory frameworks, including FDA, EMA, TGA, PMDA, Health Canada, and Medsafe
- Proven ability to interact with regulatory agencies and lead successful health authority interactions
- Strong knowledge of ICH guidelines, CTD/eCTD submissions, and regulatory lifecycle management
- Ability to communicate effectively with colleagues and stakeholders at all levels
- Ability to collaborate effectively as part of a team
- Adaptability in a dynamic environment and willingness to take on new challenges
- Commitment to ethical behavior and continuous professional development
Benefits
Comp & perks- Annual performance-based bonuses
- Equity-based incentive program
- Generous vacation
- Paid wellness days
- Support for learning and development
- Hybrid and remote work arrangements