Sun Life compliance director overseeing CIRO trade supervision and risk - based monitoring across mutual fund and securities businesses. Leading regulatory oversight, transformation, reporting, and a high - performing compliance team.
TL
Manager, Regulatory Affairs – Clinical Labeling
Posted 4 days ago
About the role
- Regulatory labeling manager overseeing global IMP labeling for Telix’s precision radiopharmaceuticals. Supporting clinical trials and regulatory compliance for cancer and rare-disease treatments.
Responsibilities
- Lead the creation, revision, review, agreement, and maintenance of Investigational Medicinal Product (IMP) and Calibration Labeling
- Collaborate with Regulatory Affairs, Clinical Operations, Quality, Contract Research Organizations, Contract Manufacturing Organizations, translation vendors, artwork vendors, and packaging vendors
- Ensure label content reflects approved protocol requirements, product characteristics, storage conditions, and country-specific requirements
- Ensure compliance with local and regional regulations and internal policies across the United States, European Union, United Kingdom, Australia, Canada, Asia-Pacific, and other participating countries
- Provide labeling expertise during protocol development, clinical study start-up, amendments, and country expansion
- Coordinate translation activities and verification of multilingual labeling content
- Coordinate artwork review and approval in the compliance system
- Manage version control and change management for IMP documentation
- Support IMP labeling submissions or notifications where required
- Evaluate new regulatory requirements and industry trends and assess impacts on studies
- Support regulatory inspections and audits with IMP documentation and subject matter expertise
- Serve as regulatory point of contact for IMP labeling, independently resolving issues and escalating complex matters
- Maintain efficient labeling processes using standardized templates, checklists, and workflows
- Identify process improvements, best practices, and tools
- Assist with other clinical or commercial labeling activities and special projects
Requirements
- Bachelor's degree in life sciences
- Minimum 5 years’ experience in pharmaceutical regulatory affairs, global labeling, clinical, or clinical operations, including at least 2 year of experience in Investigational Medicinal Product (IMP) labeling (“Clinical Labeling”)
- Experience supporting IMP (clinical) labeling for clinical trials across multiple regions and regulatory jurisdictions
- Knowledge of IMP lifecycle management
- In-depth understanding of relevant international, national, and regional regulatory and/or clinical frameworks, processes, and requirements
- Strong understanding of GMP, GCP, EU CTR, Annex VI, Annex 13, and FDA IMP requirements
- Proficiency with Microsoft Office applications and labeling management systems
- Working knowledge of Veeva is desired
- Strong communication, collaboration, adaptability, resilience, and continuous-learning capabilities
Benefits
- Competitive salaries
- 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
Tech skills
Location requirements
Report this job
Found something wrong with the page? Please let us know by submitting a report below.
Compliance Manager advising Affirm’s consumer card program on U.S. financial regulations. Reviewing card products, marketing, disputes, and remediation for compliant growth.
Compliance Manager owning risk - based advisory for Affirm Card at Affirm, which provides transparent pay - over - time financial products. Reviewing card compliance, remediation, and regulatory requirements.
Sun Life AVP leading strategic programs, innovation, insights and regulatory operations. Integrating governance, modernization, analytics and change across Canadian wealth and insurance businesses.
Senior Compliance Associate strengthening Coinbase Canada's AML, KYC, sanctions, and FINTRAC reporting program. Managing cases, risk assessments, regulatory filings, and compliance automation for cryptocurrency operations.
Quality and compliance specialist overseeing GMP, accreditation, QMS and pharmacovigilance for Shared Health Diagnostic Services in Manitoba. Ensuring regulatory compliance across provincial healthcare sites.
Compliance officer investigating energy - sector violations for British Columbia’s energy regulator. Conducting inspections, enforcement actions, emergency response, and administrative case preparation.
Senior Compliance Consultant strengthening Sun Life’s Canadian disability - management governance and risk controls. Leading audits, risk validation, business continuity, and compliance initiatives for Group Disability.
Regulatory intelligence leader monitoring global rules for Telix Pharmaceuticals, a precision radiopharmaceutical company. Translating regulatory developments into strategies, communications, and cross - functional actions.
GRC Engineer automating SOC 2, HIPAA, and vendor compliance for Clerk’s developer identity infrastructure. Building integrations, continuous controls, and audit - ready evidence workflows.