Clinical Development Solutions
Clinical Development Solutions (CDS) is a contract research organization (CRO) that provides outsourced product development and research services to pharmaceutical, biotechnology & medical device companies.
These high-quality services include:
Regulatory Affairs Advice
Quality Assurance Advice
Strategic Product Development Consulting
Protocol & Scientific Writing
Drug Safety Reporting
CDS aims to simplify Health Canada/FDA approval and entry into medical product markets as some biotech and medtech companies do not have the in house resources to perform these functions.
CDS has the capability to deliver full-service conduct of Phase I - IV clinical trials in Canada and the US. These clinical trial management services are composed of site selection, monitoring, quality assurance, project management and pre- and post-market pharmacovigilance.
CDS also offers consulting as standalone services. Thus, our professionals can function as a member of our clients’ team, delivering ongoing, integrated Regulatory, Clinical Trial and Quality Assurance advice.
CDS understands the unique needs of emerging life science and medtech companies because CDS originated in a start up. Our strategies ensure safety and integrity in medical product development while helping our clients get their products to market by the fastest and least expensive route.
Regulatory Affairs Specialist
CDS is looking for a unique individual with both a background in pharmaceutical and medical device Regulatory Affairs and the positive attitude and entrepreneurial drive to grow with our expanding client-oriented consulting firm.
This individual will posses:
Teamwork: A nature that thrives on collaboration in contributing to the success of CDS and our growing list of clients
Customer Focus: A belief in delivering excellence in Clinical Research and Regulatory Affairs services in a frequently client facing role
Flexibility: A willingness to do whatever it takes from foundational regulatory tasks to strategic project management
Attitude: A positive energy that is passionate about our mission and our clients’ missions and is looking for an opportunity to learn and advance in their Regulatory Affairs career
Regulatory Affairs professionals play a crucial role in recognizing and implementing strategies to gain medical product market approval balanced with acceptable risk. Roles and responsibilities often begin in the research and development phases, moving into clinical trials and extending through pre-market approvals, manufacturing, labeling, advertising, and post-market surveillance.
Some critical tasks for this role include:
Regulatory Strategy: Contribute to the design of product regulatory strategy with reference to key milestones and critical issues that impact cost and time.
Regulatory Research: Research and interpret regulations and guidances ensuring clients and other functional areas receive timely, and accurate advice on regulatory matters.
Regulatory Submissions: Ensure the timely preparation of components of regulatory submissions in accordance with relevant regulations and coordinate the final submission to regulatory authorities.
Strategic Contact with Regulatory Health Authorities: Conduct sensitive strategic contact with regulatory agencies such as FDA and Health Canada on behalf of clients. Ensure relevant functional areas are informed of regulatory authority communications.
Duties and Responsibilities:
· Work for and with clients to assess gaps in product regulatory plan and to design strategic solutions to close these gaps; communicate these solutions in an organized and understandable format
· Perform Canadian, U.S. and international regulatory research tasks and assists in the development of regulatory strategies in those jurisdictions
· Assist in coordinating and preparing regulatory submissions to ensure compliance with the applicable regulations and guidelines (FDA/TPD/ICH GCP/EU). Organizes the compilation, review, and approval of documents for submission
· Communicate with external sources such as clients and vendors to request and/or provide data relevant to submissions
· Assist in coordination of regulatory agency meetings, preparation of meeting materials and development of meeting game plans and communicates these details to relevant stakeholders
· Respond to Regulatory Agency communications by clarifying deficiencies and preparing strategic responses in a timely manner
· Prepare and/or review labeling, product monographs and marketing materials
· Assist in the preparation, review, and submission of required IND and post-marketing annual reports
· Provide regulatory assistance with clinical operations activities, including review of essential documents and consent forms
· Assist in the preparation and drafting of SOPs for CDS and clients
· Track regulatory project status and keep an up-to-date file of regulatory documents; organize and maintain auditable regulatory document files
· Provide regulatory support for Quality Assurance team and their projects
· Seek to continually maintain and develop regulatory knowledge in a range of jurisdictions and therapeutic areas
· Master’s degree in a scientific discipline (e.g. Chemistry, Pharmacy or Life Sciences) or equivalent
· Regulatory Affairs Certification/Diploma would be an asset
· Knowledge of FDA and Health Canada regulations and ICH guidance’s, as well as a comprehension of the drug and medical device development process
· Experience in both pharmaceutical and medical device industries
· Experience with regulatory submissions, including eCTD format
· Knowledge of international clinical trials and regulatory documentation is desirable
· Demonstrated ability to manage multiple projects and exercise good judgment in prioritizing tasks
· Must demonstrate the ability to work independently and within a group setting
· Must have strong communication skills (oral, written, and interpersonal) and the ability to take complex ideas and communicate them efficiently and effectively
· Strong ability to identify and recommend solutions to problems
· Must have a high level of attention to detail
· Proficiency with Microsoft Office applications and document formatting.
Clinical Development Solutions offers a competitive salary along with health and dental benefits, paid vacation, flexible work schedule (Monday - Friday, days) and company match RSP program is available.
Please send your cover letter and resume to firstname.lastname@example.org quoting “Regulatory Affairs Specialist” in the subject line.
Applicants must have Canadian citizenship, PR status or open work permit and ability to travel to the United States.
No LMIAs are being offered for this position.
We thank you for your interest in this position however only qualified applicants selected for an interview will be contacted.
If you have applied for this position in the last 30 days, you do not need to reapply.