Compliance Analyst supporting BeyondTrust’s cybersecurity SaaS compliance and vendor risk programs. Coordinating evidence, questionnaires, audits, policies, and cross - functional security projects.
TL
Associate Director, Global Regulatory Strategy
Posted yesterday
About the role
- Associate Director leading global regulatory strategy for Telix’s radiopharmaceutical PSMA portfolio. Managing submissions, health-authority interactions, registrations, and lifecycle compliance across markets.
Responsibilities
- 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
- 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
- Annual performance-based bonuses
- Equity-based incentive program
- Generous vacation
- Paid wellness days
- Support for learning and development
- Hybrid and remote work arrangements
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Report this job
Found something wrong with the page? Please let us know by submitting a report below.
Corporate Compliance Manager overseeing GMP compliance, product recalls, inspections, and regulatory communications. Supporting Apotex, a Canadian pharmaceutical company providing affordable medicines and health products.
Responsable qualité et conformité chez Pharmascience, fabricant pharmaceutique canadien. Supervision des programmes réglementaires, audits, qualité, formation et conformité corporative.
Raw material compliance consultant supporting ingredient reviews and regulatory dossiers for ClinChoice, a global CRO. Assessing cosmetic compliance across FDA, EU, Health Canada, and ASEAN regulations.
Compliance Associate supporting Clarity’s private - market liquidity platform. Managing transaction monitoring, regulatory filings, representative oversight, and US/Canadian compliance infrastructure.
Compliance manager for Nordex, a global onshore wind - turbine manufacturer. Enforcing prevailing wage and apprenticeship requirements across renewable - energy projects.
Regulatory Affairs Manager authoring CMC dossiers and global submissions for Telix’s radiopharmaceutical and biopharmaceutical pipeline. Supporting products for cancer and rare diseases.
Compliance Officer owning LemFi's Canadian AML programme for its global financial services platform. Managing FINTRAC, RPAA, audits, filings, and banking - partner compliance.
Process and compliance technician supporting Ontario Clean Water Agency water and wastewater treatment operations. Implementing environmental compliance, process control, auditing and health and safety programs.
Privacy Counsel and DPO overseeing global privacy compliance for a robotics AI data infrastructure company. Managing consent, cross - border transfers, incidents, regulators, and privacy - by - design controls.