Senior Specialist, Regulatory Operations

Summary

Join Care Access as a Senior Specialist, Regulatory Operations and oversee site-level regulatory activities for clinical trials in Canada, ensuring compliance with Canadian regulations. Support regulatory activities for U.S. sites as needed. You will provide regulatory advice, lead and execute regulatory projects, and assist with sponsor monitoring visits. Develop and implement regulatory strategies, guide site operations teams, and track essential documents and timelines. Manage REB/IRB submissions, review regulatory submission materials, and liaise with sponsors. Maintain compliance, support study close-out activities, and provide guidance to site staff. Collaborate with cross-functional teams and stay updated on regulatory changes. Identify process gaps and support continuous improvement initiatives. This remote position requires less than 10% travel.

Requirements

• Ability to communicate and work effectively with a diverse team of professionals
• Strong organizational skills : Able to prioritize, delegate, direct, support, assign and evaluate others work and follow through on assignments
• Communication Skills: Strong verbal and written communication skills as evidenced by positive interactions with coworkers, management, clients, and vendors
• Team Collaboration Skills : Work effectively and collaboratively with other team members to accomplish mutual goals. Bring positive and supportive attitude to achieving these goals
• Strong computer skills with demonstrated abilities using clinical trials database, MS word and excel
• Experience in electronics Investigator Site Files systems like (Florence, CRIO)
• Ability to balance tasks with competing priorities
• Curiosity and passion to learn, innovate, able to take thoughtful risks and get things done
• Friendly, outgoing personality with the ability to maintain a positive attitude under pressure
• High level of self-motivation and energy
• Ability to work independently in a fast-paced environment with supervision
• Must have a client service mentality
• Demonstrated success in managing REB/IRB and regulatory submissions, including Health Canada interactions
• Detail-oriented with strong problem-solving abilities and a proactive approach to regulatory challenges
• Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment
• Strong strategic planning, risk management, managing, monitoring and change management skills
• Bachelor's degree in a scientific or healthcare-related field; advanced degree preferred or equivalent experience
• Minimum of 5 years of experience in operational regulatory affairs within there search site (preferable), or CRO/pharmaceutical industry, with a focus on Canadian and USA regulatory requirements
• Strong understanding of Health Canada, USA regulations and ICH GCP guidelines as they relate to site operations
• Excellent knowledge of site-level regulatory requirements for the execution and maintenance of clinical trials in Canada
• Proven ability to support Canadian sites in ethics submissions, regulatory document preparation, and ongoing compliance
• This role requires 100% of work to be performed in a remote office environment and requires the ability to use keyboards and other computer equipment
• This is a remote position with less than 10% travel requirements

Responsibilities

• Provide regulatory advice, lead, execute and deliver regulatory project work
• Support regulatory compliance activities for Canadian and USA clinical research sites, ensuring to adherence to Health Canada, FDA and global regulatory standards
• Assist in preparing for sponsor monitoring visits and follow up requirements
• Develop and implement regulatory strategies to support sites activities
• Provide regulatory guidance to the site operations teams, ensuring that activities align with current regulations and industry best practices
• Track essential documents and timelines
• Support the site(s) through the Site Evaluation Visit, Site Initiation Visit, greenlight to consent, and Study Closeout
• Actively work towards KPIs to help ensure departmental success
• Support creation and maintenance of study Delegation of Authority (DOA) logs
• Oversee activities throughout the duration of the study; supporting clinical operations teams as required
• Coordinate and manage REB/IRB site level submissions and maintenance of approvals throughout the life of the study/ies
• Review, and submit high-quality and timely regulatory agency submission materials, including but not limited to protocols, ICFs and marketing materials
• Reviews and customize, when required, ICFs to ensure compliance with Canadian REB requirements and site feedback
• Liaise and follow up directly with Sponsor
• Ensures accurate compilation, management and tracking of submissions
• Oversee regulatory documentation, tracking, and reporting processes to maintain compliance and readiness for regulatory inspections and sponsor audits
• Milestones: Tracks and updates the study team accordingly
• Ensure timely filing of safety reports, deviations, and amendments/modifications as per study requirements
• Ensure that Investigator Site File (ISFs) are completed, up to date, accurate and in compliance with Good Clinical Practice (GCP), regulatory requirements and internal processes
• Oversee and support study close-out activities by ensuring proper archiving and retention of ISF documents
• Provide guidance and support to site staff with regards to regulatory intelligence and country requirements, including identifying and conducting training
• Coordinate preparation and review of key site essential documents
• Collaborate with cross-functional teams, including Quality and Clinical Operations, to ensure regulatory requirements are met
• Monitor and interpret changes in Canadian and USA regulatory policies and guidelines, advising internal stakeholder on potential impacts
• Stay updated on evolving regulations, guidelines, and industry best practices to ensure compliance and adjust strategies
• Identify process gaps, and support the development, implementation, and continuous improvement of new departmental processes
• Support the development, review, and maintenance of departmental Standard Operating Procedures (SOPs), work instructions, and forms
• Perform other duties as assigned