Senior Global Regulatory Scientist

Role Overview

• Ensuring regulatory deliverables are performed in accordance with all relevant regulations, guidelines, policies and procedures within contractual timelines and budget with sound scientific/technical principles.
• Developing the overall and global clinical trial submission strategy in accordance with the project requirements in collaboration with stakeholders including proactive identification and mitigation of risks, as applicable.
• Regulatory function team lead overseeing the assigned clinical trial Regulatory project team.
• Point of contact for clients for clinical trial Regulatory deliverables.
• Preparation of clinical trial Regulatory plan in accordance with project specifications.
• Preparation/creation/adaptation/coordination/collation/compliance of global core documents considering strategic, scientific and therapeutic area principles in addition to study requirements.
• Tracking and reporting of submission/approval progress in Clinical Trials Management System (CTMS), eTMF and other applicable systems ensuring accuracy and completeness of data/documents.
• Performing Quality Control review of clinical trial Regulatory deliverables in accordance with applicable process.
• Coordinating submission(s) to regulatory agencies (RAs), central ethics committees (CECs), and all other country-level submissions in collaboration with stakeholders, overseeing the assigned Regulatory project team.
• Coordination of clinical trial label review/approval according to project specifications.
• Managing Regulatory study budget, proactively identifying out of scope activities and supporting budget recognition.
• Supporting the maintenance of accurate, up to date Country and Regulatory Intelligence.
• May work with Regulatory team members to provide Regulatory consulting services.
• May participate in business development activities.
• May mentor junior team members.

Requirements

• Bachelor's degree in a scientific discipline or related field.
• Minimum of 3 years’ of experience in regulatory affairs submissions within the clinical research industry.
• Demonstrates complete understanding and application of clinical research regulations, concepts and standards.
• Strong understanding of global regulatory requirements and guidelines.
• Demonstrates a good understanding of country requirements and how they need to be applied in the clinical trial environment.
• Proven history of successful interaction with internal and client teams and a basic understanding of each related function.
• Excellent English communication and social skills.
• Ability to work independently and collaboratively in a fast-paced environment.

Benefits

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.