Associate Director leading global regulatory strategy for Telix’s radiopharmaceutical PSMA portfolio. Supporting worldwide submissions, approvals, lifecycle management, and health - authority interactions.
About the role
- Regulatory Consultant using Veeva Vault RIM to coordinate drug regulatory submissions for Syneos Health. Supporting Vertex submission managers with publishing, project tracking, and content planning.
Responsibilities
- Create and maintain content plans within Veeva Vault RIM
- Translate Smartsheet timelines into Microsoft Project and Veeva Vault RIM
- Assist with planning, managing, and tracking regulatory submissions
- Support Vertex Global Submission Managers with project management activities, tasks, and tracking
- Assist with coordination and communication of regulatory submissions to Vertex Publishing
- Work with firm deadlines and adapt quickly to changing requirements and priorities
Requirements
- Create and maintain content plans within Veeva Vault RIM
- Translate Smartsheet timelines into Microsoft Project and Veeva Vault RIM
- Assist with planning, managing, and tracking regulatory submissions
- Experience supporting project management activities, tasks, and tracking
- Ability to coordinate and communicate regulatory submissions to Vertex Publishing
- Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
- Excellent organization, written/verbal communication, and attention to detail
- Proficiency in electronic submission tools and software, such as eCTD and regulatory information management systems
- Knowledge of Insight Publisher, Lorenz Publisher, Veeva Vault RIM, Content Planning, eCTD Viewers, and DXC (ISI) Toolbox
- Experience and proficiency with project management tools and software
- Knowledge of Smartsheet, Microsoft Project, Excel, and Office timeline Pro
- B.S. (or equivalent experience) and 5+ years of Regulatory Affairs work experience, focused on publishing and/or submissions; or M.S. (or equivalent experience) and 3+ years of Regulatory Affairs work experience, focused on publishing and/or submissions
- In-depth understanding of FDA regulations, EMA guidelines, and ICH standards
- Knowledge of eCTD, NDA, IND, EU CTA, MAA, EU CTR, and NDS
Benefits
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Inclusive culture
- Reasonable accommodations, when appropriate, for employees or applicants with disabilities
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 overseeing complex account opening, KYC and AML compliance for Fidelity Clearing Canada. Supporting regulatory monitoring, training, reporting and risk workflows.
Data Protection Specialist leading privacy assessments, controls, and compliance for Fidelity Canada’s investment services. Advising business and technology teams while mitigating data protection risks.
Privacy and regulatory compliance manager leading Plooto’s privacy program and responsible AI governance. Supporting risk management and compliance for its Canadian payment automation platform.
Director leading Board and committee compliance reporting for Sun Life, a global financial services company. Developing KRI metrics, regulatory insights and risk narratives for senior leadership.
Health Compliance Officer inspecting continuing care homes for Government of Alberta. Conducting investigations, compliance reviews, and regulatory oversight across Alberta.
Regulatory Strategist guiding Latin American drug submissions and lifecycle management for Syneos Health’s life sciences services. Providing regional expertise, coordinating authorities, and leading cross - functional submission teams.
Billing Compliance Analyst ensuring accurate matter setup, rates, and invoices. Supporting eBilling compliance and reporting for Canadian law firm McCarthy Tétrault.
Senior Compliance Analyst maintaining Canadian securities and crypto compliance programs at Crypto.com. Translating CSA and CIRO requirements into policies, controls, training, and operational practices.
GRC/Compliance Lead guiding SOC 2, ISO, and customer assurance for enterprise AI platforms. Building practical compliance into regulated, mission - critical software delivery.