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Added 42 mins ago
H
Project Manager/Estimator, Service
Houle
Burnaby, BC
- Full-time
We are recruiting for an energetic, business savvy, and driven Project Manager/Estimator, Service Projects to join our Service division in our Burnaby office. Here's how your role will…
Added 42 mins ago
NH
Clinical Supervisor (Temporary, Full-Time)
Northumberland Hills Hospital
Cobourg, ON
- Full-time
Reporting to the Patient Care Manager (PCM), the Clinical Supervisor (CS) is a leader who facilitates and mentors the interprofessional team to effectively manage of care delivery,…
Added 1 hour ago
C
Information Technology Operations Manager
Cardata
Canada
- $80,000 to $120,000 CAD / year
- Full-time
As the IT Operations Manager you will be the go-to person for all things about our IT Operations at Cardata.
Added 2 hours ago
FH
Registered Nurse, Medicine - Burnaby Hospital
Fraser Health
Burnaby, BC
- Full-time
The Burnaby Hospital redevelopment project is a multi-phase project that will transform the hospital into a modernized medical and surgical health care campus. Phase one is slated to open…
Added 2 hours ago
K
Manager - Governance, Risk & Compliance Services / Internal Audit and Internal Controls in Halifax
KPMG
Halifax, NS
- Full-time
Added 2 hours ago
K
Manager, People & Change
KPMG
Ottawa, ON
- Full-time
As a Manager in our People & Change practice, you will support the delivery of client engagements, contribute to project execution, and play an active role in developing team capabilities…
Added 4 hours ago
ES
Senior Consultant (BudgetPro)
Euna Solutions
Oakville, ON
- Full-time
At least 5 years of experience in software development (and/or implementations), consulting, or project management, resulting in SME-level expertise in consulting, engagement management,…
Added 7 hours ago
PR
Project Manager
PuroClean Restoration Markham - Scarborough
Toronto, ON · Etobicoke, ON
- Full-time
Role Description The Project Manager is a full-time, on-site role based in Etobicoke, ON, responsible for overseeing restoration projects from initial assessment through completion. Daily…
Added 7 hours ago
TH
Associé(e) mise en marché (temps plein) temporaire 90 jours
The Home Depot Canada
Montreal, QC
- Full-time
Read and interpret directions to ensure merchandise is set to the planogram, project instructions, program service requirements and general service guidelines
Added 7 hours ago
LG
Senior Project Manager (Engineering)
Liftsafe Group of Companies
Cambridge, ON
- Full-time
The Senior Project Manager is responsible for the successful delivery of complex crane, lifting equipment, structural steel, and custom fabrication projects from contract award through…
Added 7 hours ago
G
General Manager in Training
Groundworks
Burlington, ON
- Full-time
At Groundworks, we invest in people who are ready to lead, grow, and make an impact. Our Branch Manager Training Program (BMTP) is a six-month immersive development experience designed to…
Added 8 hours ago
TH
Associé(e), plomberie/électricité (temps plein)
The Home Depot
Canada
- Full-time
…are familiar with related items in order to sell an entire project. Associates in this position know how to greet, engage, and thank every customer in their department and know how to…
Added 10 hours ago
SM
Medical Radiation Technologist (CT & X-Ray)
Stevenson Memorial Hospital
Alliston, ON
- Full-time
Join a forward-thinking organization with an exciting future. As part of a major hospital redevelopment project scheduled for Fall 2028, staff will have the opportunity to work in a…
Added 10 hours ago
SM
Medical Radiation Technologist (CT & X-Ray)
Stevenson Memorial Hospital
Alliston, ON
- Internship
Join a forward-thinking organization with an exciting future. As part of a major hospital redevelopment project scheduled for Fall 2028, staff will have the opportunity to work in a…
Added 10 hours ago
SM
Medical Radiation Technologist (CT & X-Ray)
Stevenson Memorial Hospital
Alliston, ON
- Full-time
Join a forward-thinking organization with an exciting future. As part of a major hospital redevelopment project scheduled for Fall 2028, staff will have the opportunity to work in a…
Added 10 hours ago
SM
Medical Radiation Technologist (CT & X-Ray)
Stevenson Memorial Hospital
Alliston, ON
- Internship
Join a forward-thinking organization with an exciting future. As part of a major hospital redevelopment project scheduled for Fall 2028, staff will have the opportunity to work in a…
Added 10 hours ago
CO
Manager Policy and Risk Management
City of Saint John
Saint John, NB
- Full-time
The Manager Policy and Risk Management is responsible for research and analysis, policy and procedures, and risk management.
Added 10 hours ago
CO
Temporary Solutions Integration Specialist (up to 8 months)
City of Saint John
Saint John, NB
- Temporary
Under the direction of the IT Manager, the position is responsible for administration, implementation, and maintenance of the City’s website, web-based applications, software, data…
Added 10 hours ago
CO
Manager, Digital Solutions
City of Saint John
Saint John, NB
- Full-time
The Manager, Digital Solutions, is responsible for the delivery and ongoing management of the City’s enterprise applications, digital solutions, and data and information management…
Added 10 hours ago
CO
Application & Integration Technical Analyst
City of Saint John
Saint John, NB
- Full-time
Under the direction of the designated IT Manager, the Application and Integration Technical Analyst is a technical lead responsible for system architecture, data strategy, and integration…
Added 10 hours ago
Conference Services Manager
Coast Hotels
Canmore, AB
…restaurant, Table Food + Drink. We are seeking a Conference Services…
Added 10 hours ago
NA
Senior Security Systems Technician
New Age Group
Concord, ON
- Full-time
Added 10 hours ago
NA
Apprentice Security Systems Technician
New Age Group
Concord, ON
- $22 CAD / hour
- Full-time
Reports to Lead Technician/Operations Manager
Added 10 hours ago
NA
Level II Security Systems Technician
New Age Group
Concord, ON
- $45 USD / hour
- Full-time
Added 10 hours ago
NA
Labourer
New Age Group
Concord, ON
- $28 CAD / hour
- Full-time
Reports to: Lead Technician/Operations Manager

Closed listing

Telix Pharmaceuticals (AMER)

Senior Manager, Global Regulatory Strategy

Canada

This opening has closed.

The original listing is kept below for reference.

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About employer

Job details

Experience: 8+ years of experience in Regulatory Affairs, with strong early-stage (IND/CTA) submission experience.
Posting language: English
Posted: Sep 28, 2026

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Original job description

Archived listing. The details below describe a past opening.

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.

See Yourself at Telix

The Senior Manager, Global Regulatory Strategy oversees regulatory activities for the assigned early-stage portfolio across global markets. Reporting to the VP, Global Regulatory Strategy, this individual-contributor role executes the global regulatory strategy for assigned assets, planning and delivering high-quality submissions from IND/CTA through to early registration. As a key contributor to the Regulatory Strategy team, the Senior Manager provides regulatory expertise for early-stage programs, prepares health authority interactions, and supports the VP on global regulatory planning and cross-functional initiatives that accelerate development.

Key Accountabilities:

Regulatory Strategy & Planning

Contribute to and execute the global regulatory strategy for assigned early-stage assets, planning IND/CTA submissions in collaboration with cross-functional teams and under the direction of the VP, Global Regulatory Strategy.
Develop submission plans, timelines, and content requirements for assigned programs, ensuring alignment with development milestones and corporate objectives.
Support the development of registration strategies and manage the registration process for assigned early-stage assets in collaboration with cross-functional teams.

Health Authority Interactions

Prepare briefing packages and supporting materials for health authority meetings on early-stage filings; draft meeting minutes and responses to agency questions with senior review.
Interface with FDA, EMA, TGA, PMDA, and other health authorities for assigned filings, ensuring submissions meet regulatory requirements and deadlines.

Cross-Functional Collaboration

Partner with QA, Clinical Development, Research & Innovation, and other functions to assemble compliant, on-time dossiers for assigned assets.
Provide regulatory guidance to project teams on assigned early-stage programs.

Risk Management & Compliance

Identify regulatory risks on assigned programs and recommend mitigation plans to the VP, Global Regulatory Strategy.
Monitor evolving global health authority regulations and guidelines, maintaining submission compliance for assigned assets.
Manage responses to health authority queries, variations, and post-approval requirements for assigned early-stage programs.

Position Requirements

Education and Experience:

Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field (advanced degree preferred).
8+ years of experience in Regulatory Affairs, with strong early-stage (IND/CTA) submission experience.
Strong experience in clinical regulatory submissions (CTAs, INDs) and early-stage development. Working knowledge of global regulatory frameworks (FDA, EMA, TGA, PMDA, Health Canada, Medsafe).
Experience preparing for and supporting health authority interactions. Strong knowledge of ICH guidelines, CTD/eCTD submissions, and the regulatory lifecycle

Key Capabilities:

Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills

At Telix, we believe everyone counts, we strive to be extraordinary, and we pursue our goals with determination and integrity. You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.

Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.

VIEW OUR PRIVACY POLICY HERE

About employer

More about this job

Responsibilities

The Senior Manager oversees global regulatory strategy for early-stage assets, planning and executing high-quality IND/CTA submissions. They also manage health authority interactions and provide regulatory guidance to cross-functional teams to ensure compliance and project success.

Requirements

Candidates must hold a bachelor's degree in a life sciences field and possess over 8 years of experience in regulatory affairs. Strong expertise in clinical regulatory submissions and knowledge of global regulatory frameworks like FDA, EMA, and PMDA are required.

Skills

Regulatory strategy
IND/CTA submissions
Clinical regulatory submissions
Health authority interactions
Regulatory compliance
Risk management
Oncology
Rare diseases
Project management
Cross-functional collaboration
ICH guidelines
CTD/eCTD submissions
Strategic planning
Communication
Analytical thinking

Benefits

Competitive salaries
Annual performance-based bonuses
Equity-based incentive program
Generous vacation
Paid wellness days
Learning and development support

Visa sponsorship

Not detected in the job text

Keywords

Regulatory Affairs
Radiopharmaceuticals
Oncology
Precision Medicine
IND
CTA
FDA
EMA
TGA
PMDA
ICH Guidelines
CTD
eCTD
Clinical Development
Regulatory Strategy
Submission Planning
Compliance
Risk Mitigation
Life Sciences
Global Regulatory Frameworks
Dossier Assembly
Health Authority
Prostate Cancer
Rare Diseases
Regulatory Lifecycle

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