Current jobs related to Regulatory Affairs Consultant m/w - Québec, Quebec - Syneos Health
-
Regulatory Affairs Director
1 month ago
Québec, Quebec, Canada Parexel Full timeLead Regulatory Affairs ExpertParexel is seeking a seasoned Regulatory Affairs professional to lead our team and drive strategic growth in the life sciences industry.Key Responsibilities:Develop and implement regulatory strategies to ensure compliance and drive business growthLead a high-performing team of Regulatory Affairs professionals and provide...
-
Regulatory Affairs Director
1 month ago
Québec, Quebec, Canada Parexel Full timeLead Regulatory Affairs ExpertParexel is seeking a seasoned Regulatory Affairs professional to lead our team and drive strategic growth in the life sciences industry.Key Responsibilities:Develop and implement regulatory strategies to ensure compliance and drive business growthLead a high-performing team of Regulatory Affairs professionals and provide...
-
Regulatory Affairs Director
1 month ago
Québec, Quebec, Canada Parexel Full timeLead Regulatory Affairs TeamParexel is seeking a seasoned Regulatory Affairs Director to lead our Regulatory Affairs team. As a key member of our leadership team, you will be responsible for providing strategic guidance and technical expertise to drive regulatory success.Key Responsibilities:Develop and implement regulatory strategies to ensure compliance...
-
Regulatory Affairs Director
1 month ago
Québec, Quebec, Canada Parexel Full timeLead Regulatory Affairs TeamParexel is seeking a seasoned Regulatory Affairs Director to lead our Regulatory Affairs team. As a key member of our leadership team, you will be responsible for providing strategic guidance and technical expertise to drive regulatory success.Key Responsibilities:Develop and implement regulatory strategies to ensure compliance...
-
Regulatory Affairs Director
4 weeks ago
Québec, Quebec, Canada Parexel Full timeLead Regulatory Affairs ExpertParexel is seeking a seasoned Regulatory Affairs Director to join our team. As a key member of our organization, you will be responsible for leading and mentoring a team of high-performing Regulatory Affairs professionals, providing strategic, technical, and regulatory advice to clients, and managing client relationships.Key...
-
Regulatory Affairs Director
4 weeks ago
Québec, Quebec, Canada Parexel Full timeLead Regulatory Affairs ExpertParexel is seeking a seasoned Regulatory Affairs Director to join our team. As a key member of our organization, you will be responsible for leading and mentoring a team of high-performing Regulatory Affairs professionals, providing strategic, technical, and regulatory advice to clients, and managing client relationships.Key...
-
Regulatory Affairs Specialist
3 weeks ago
Québec, Quebec, Canada Innomar Strategies Full timeAt Innomar Strategies, we're united in our responsibility to create healthier futures. Our team members are at the heart of everything we do, and every person here is essential to delivering on that purpose.Job SummaryWe're seeking a highly skilled Regulatory Affairs Specialist to join our innovative company. As a key member of our team, you'll play a...
-
Bauingenieur (w/m/d) - Bauüberwachung
2 weeks ago
Québec, Quebec, Canada BKW Engineering Full timeBauingenieur (w/m/d) - BauüberwachungWir suchen einen erfahrenen Bauingenieur (w/m/d) für die Position des Bauüberwachung. Als Teil unseres Teams werden Sie verantwortlich für die Bauüberwachung und die Sicherstellung der Einhaltung von Terminen, Kosten und Qualitätsstandards.Ihre AufgabenBauoberleitung und örtliche BauüberwachungSelbstständige...
-
Senior Regulatory Affairs Specialist
1 month ago
Québec, Quebec, Canada Parexel Full timeJoin Our Team as a Senior Regulatory Affairs ConsultantAbout the RoleWe are seeking a highly skilled Senior Regulatory Affairs Consultant to join our team at Parexel. As a key member of our regulatory affairs department, you will play a critical role in ensuring the compliance of our clients' products with global regulatory requirements.Key...
-
Senior Regulatory Affairs Specialist
1 month ago
Québec, Quebec, Canada Parexel Full timeJoin Our Team as a Senior Regulatory Affairs ConsultantAbout the RoleWe are seeking a highly skilled Senior Regulatory Affairs Consultant to join our team at Parexel. As a key member of our regulatory affairs department, you will play a critical role in ensuring the compliance of our clients' products with global regulatory requirements.Key...
-
Regulatory Affairs Specialist
2 weeks ago
Québec, Quebec, Canada Innomar Strategies Full timeAt Innomar Strategies, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for coordinating and compiling regulatory submissions, responses to agency questions, and other correspondence in accordance with requirements for assigned projects. You will apply your...
-
Regulatory Consulting Director
2 months ago
Québec, Quebec, Canada Syneos Health Full timeSyneos Health is a leading fully integrated biopharmaceutical solutions organization. Our mission is to accelerate customer success by translating unique clinical, medical affairs, and commercial insights into outcomes. As a Manager, Regulatory Consulting, you will be responsible for leading our regulatory consulting team to ensure compliance with regulatory...
-
Regulatory Consultant
1 month ago
Québec, Quebec, Canada Syneos Health Full timeJob Title: Regulatory ConsultantAt Syneos Health, we are seeking a highly skilled Regulatory Consultant to join our team. As a key member of our regulatory department, you will be responsible for contributing to the planning and execution of regulatory submissions in assigned regions/countries/projects.Key Responsibilities:Contribute to the planning and...
-
Regulatory Consultant
1 month ago
Québec, Quebec, Canada Syneos Health Full timeJob Title: Regulatory ConsultantAt Syneos Health, we are seeking a highly skilled Regulatory Consultant to join our team. As a key member of our regulatory department, you will be responsible for contributing to the planning and execution of regulatory submissions in assigned regions/countries/projects.Key Responsibilities:Contribute to the planning and...
-
Regulatory Affairs Director
4 weeks ago
Québec, Quebec, Canada Syneos Health Full timeJob Title: Associate Director, Regulatory AffairsAt Syneos Health, we are seeking an experienced Associate Director, Regulatory Affairs to join our team. As a key member of our regulatory department, you will be responsible for contributing to the planning and execution of regulatory submissions in assigned regions/countries/projects.Key...
-
Regulatory Affairs Director
4 weeks ago
Québec, Quebec, Canada Syneos Health Full timeJob Title: Associate Director, Regulatory AffairsAt Syneos Health, we are seeking an experienced Associate Director, Regulatory Affairs to join our team. As a key member of our regulatory department, you will be responsible for contributing to the planning and execution of regulatory submissions in assigned regions/countries/projects.Key...
-
Regulatory Consulting Manager
1 month ago
Québec, Quebec, Canada Syneos Health Full timeRegulatory Consulting ManagerAt Syneos Health, we are seeking a highly skilled Regulatory Consulting Manager to join our team. As a key member of our organization, you will be responsible for providing expert guidance on regulatory matters to ensure compliance with industry standards and regulations.Key Responsibilities:Develop and implement regulatory...
-
Regulatory Consulting Manager
2 months ago
Québec, Quebec, Canada Syneos Health Full timeAbout the RoleWe are seeking a highly skilled Regulatory Consulting Manager to join our team at Syneos Health. As a key member of our regulatory department, you will be responsible for managing regulatory submissions, leading project teams, and providing strategic advice to clients.Key ResponsibilitiesContribute to the planning and preparation of regulatory...
-
Regulatory Consulting Manager
2 months ago
Québec, Quebec, Canada Syneos Health Full timeAbout the RoleWe are seeking a highly skilled Regulatory Consulting Manager to join our team at Syneos Health. As a key member of our regulatory department, you will be responsible for managing regulatory submissions, leading project teams, and providing strategic advice to clients.Key ResponsibilitiesContribute to the planning and preparation of regulatory...
-
Regulatory Consultant
2 months ago
Québec, Quebec, Canada Syneos Health Full timeAbout the RoleWe are seeking a highly skilled Regulatory Consultant to join our team at Syneos Health. As a key member of our regulatory department, you will be responsible for contributing to the planning and execution of regulatory submissions in assigned regions and countries.Key ResponsibilitiesContribute to the preparation of regulatory submissions,...
Regulatory Affairs Consultant m/w
3 months ago
Regulatory Affairs Consultant - Hybrid Work Environment
Syneos Health stands as a premier, fully integrated biopharmaceutical solutions provider dedicated to expediting client success. We transform distinctive clinical, medical affairs, and commercial insights into tangible outcomes that address contemporary market challenges.
Our Clinical Development framework places both the client and the patient at the forefront of our operations. We are persistently seeking methods to simplify and enhance our processes, ensuring that Syneos Health is not only a preferred partner but also a desirable workplace.
Whether you engage with us in a Functional Service Provider partnership or a Full-Service model, you will collaborate with enthusiastic problem solvers, innovating collectively to assist our clients in reaching their objectives. Our agility drives us to hasten the delivery of therapies, fueled by our commitment to making a difference in lives.
Key ResponsibilitiesGeneral Responsibilities: Accountable for delivering quality outputs at the national level; adheres to project specifications and relevant national regulations with minimal supervision from the Site Start-Up Country Manager.
- Anticipates submission and approval timelines, ensures adherence to compliance, and monitors milestone progress in the designated tracking system in real-time. If projected timelines are not met, analyzes data to provide a clear explanation for delays, proposes contingency strategies to mitigate impacts, and escalates issues promptly.
- Oversees financial aspects of projects and monitors the allocation of hours/tasks as per contract; reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner, maintains updated training records, and ensures compliance with timesheet submissions.
- Facilitates continuous enhancement of quality across all Site Start-Up (SSU) components at the national level, including submissions, essential document collection, and communication with Competent Authorities and Ethics Committees.
Local Submissions Specialist: Adheres to project directives and expertise provided by the designated country start-up advisor and Project Manager/Site Start-Up Lead. May act as the primary liaison for the Project Manager/Site Start-Up Lead during the start-up phase of assigned projects.
- Compiles and/or reviews essential document packages necessary for site activation and may also assist in the collection of essential documents from the site.
- Prepares and submits Central Ethics Committee Applications, Local Ethics Committee Applications, Regulatory Authority Applications, and other submissions to local regulatory bodies or hospital approvals as required.
Oversees continuous submissions, amendments, and periodic notifications required by central and local Ethics Committees and Regulatory Authorities, including safety notifications as mandated by local regulations, with minimal oversight from the Site Start-Up Country Manager.
Country Start-Up Advisor: Serves as a Subject Matter Expert for in-country performance within Site Start-Up, providing country-level insights on start-up and clinical trial regulatory matters.
Ensures that local regulatory intelligence related to the activities of the local Site Start-Up and Clinical Trial Regulatory team is maintained in a central repository, including submissions to Competent Authorities, Ethics Committees, notifications to data protection authorities, and import/export license applications where applicable.
In the absence of a legal advisor or subject matter expert for data protection, provides clear guidance on data protection statements that must be included in documents contracted by the Sponsor to the Company start-up group for local compliance.
Local Site ID and Feasibility SupportProvides assistance to the site selection lead and Project Manager/Site Start-Up Lead to ensure appropriate sites are chosen for individual studies based on clinical trial requirements.
- Local Investigator Contract and Budget Negotiator: Generates site-specific contracts from the national clinical trial agreement template. Reviews and manages site-specific contracts, submits proposed contracts and investigator budgets for site review, and negotiates budget and contract terms with the site until resolution.
- Line Management / Mentoring Responsibilities: May be requested to support management in activities such as interviewing, professional development, performance management, and employee counseling. Advises junior team members on administrative policies, technical issues, priorities, and methodologies.
- Bachelor's Degree
- Experience in project management within a dynamic environment
- Strong organizational capabilities with a proven ability to manage multiple projects
- Quality-focused in all managed activities
- Ability to mentor, lead, and inspire junior staff
- Demonstrated capacity to provide constructive feedback and guidance to peers
- Contribute to the development of training and quality assurance plans within Site Start-Up and update SOPs/WIs
Syneos Health has collaborated with a significant percentage of all Novel FDA Approved Drugs, EMA Authorized Products, and numerous studies across a vast network of sites and trial participants.
We are committed to compliance with all applicable legislation in the countries where we operate, including the implementation of the EU Equality Directive regarding recruitment and employment practices.
Syneos Health is dedicated to adhering to the Americans with Disabilities Act, providing reasonable accommodations when necessary to assist employees or applicants in performing essential job functions.
