Regulatory Affairs Scientist
1 day ago
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
We are continuously building the company we all want to work for and our customers want to work with. Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong.Job Responsibilities- Process, review and evaluate chromatograms by using dedicated computer applications.
- Perform electronic data transfers from various acquisition systems.
- Verify and evaluate generated raw data by ensuring the consistency of the sequence of events.
- Verify the accuracy of raw data included in various tables.
- Ensure that the answers are received regarding observations and that appropriate corrections are performed.
- Communicate information to the responsible of the study and management in order to ensure the smooth conduct of the project.
- Can be called upon to prepare and review documents during regulatory agency visits.
- Interpret analysis results and give his opinion to the management and to the responsible of the study on the data or the tests to be done in order to help to the conduct of the study.
- Responsible for performing activities that are in compliance with applicable Corporate and Divisional Policies, Standard Operating Procedures and Operating Guidelines and performing other duties as assigned by management.
- College or Bachelor’s degree in science or other appropriate field.
-
Regulatory Affairs Project Lead
4 weeks ago
Montreal, Canada Knight Therapeutics Full timeAbout the RoleKnight Therapeutics Inc., a leading pan-American specialty pharmaceutical company, is seeking a highly skilled Regulatory Affairs Project Manager to support its business growth in Canada and 10 countries in Latin America.As a key member of the Regulatory Affairs team, you will be responsible for ensuring timely filing and approval of...
-
Regulatory Affairs Project Manager
2 weeks ago
Montreal, Canada Knight Therapeutics Full timeKnight Therapeutics Inc., headquartered in Montreal, is a pan-American (ex-US) specialty pharmaceutical company helping patients in Canada and 10 countries in Latin America. Knight Therapeutics Inc. is focused on acquiring, in licensing, out-licensing, marketing, and commercializing innovative prescription pharmaceuticals in Canada and Latin America. Role ...
-
Regulatory Affairs Project Manager
2 weeks ago
Montreal, Canada Knight Therapeutics Full timeKnight Therapeutics Inc., headquartered in Montreal, is a pan-American (ex-US) specialty pharmaceutical company helping patients in Canada and 10 countries in Latin America. Knight Therapeutics Inc. is focused on acquiring, in licensing, out-licensing, marketing, and commercializing innovative prescription pharmaceuticals in Canada and Latin...
-
Regulatory Affairs Project Manager
4 weeks ago
Montreal, Canada Knight Therapeutics Full timeKnight Therapeutics Inc., headquartered in Montreal, is a pan-American (ex-US) specialty pharmaceutical company helping patients in Canada and 10 countries in Latin America. Knight Therapeutics Inc. is focused on acquiring, in licensing, out-licensing, marketing, and commercializing innovative prescription pharmaceuticals in Canada and Latin...
-
Regulatory Affairs Project Manager
2 weeks ago
Montreal, Canada Knight Therapeutics Full timeKnight Therapeutics Inc., headquartered in Montreal, is a pan-American (ex-US) specialty pharmaceutical company helping patients in Canada and 10 countries in Latin America. Knight Therapeutics Inc. is focused on acquiring, in licensing, out-licensing, marketing, and commercializing innovative prescription pharmaceuticals in Canada and Latin...
-
Regulatory Affairs Specialist
2 weeks ago
Montreal, Quebec, Canada Pharmascience Inc. Full timePharmascience Inc. is seeking a highly skilled Regulatory Affairs Specialist to join our team in Montreal, Quebec, Canada.The estimated salary for this position is $80,000 - 100,000 CAD per year, depending on experience.About the JobThis is a 6-month contract role with the opportunity to extend or transition into a permanent position.Job DescriptionAs a...
-
Regulatory Affairs Project Manager
1 month ago
Montreal, Quebec, Québec, Canada Knight Therapeutics Full timeKnight Therapeutics Inc., headquartered in Montreal, is a pan-American (ex-US) specialty pharmaceutical company helping patients in Canada and 10 countries in Latin America. Knight Therapeutics Inc. is focused on acquiring, in licensing, out-licensing, marketing, and commercializing innovative prescription pharmaceuticals in Canada and Latin...
-
Montreal, Quebec, Canada Pharmascience Full timePharmascience is seeking a highly skilled Regulatory Affairs Specialist to join our team in Montreal, Quebec. As a key member of our regulatory affairs department, you will be responsible for ensuring the timely and compliant maintenance of our products.About the RoleThis is an exciting opportunity to work with a leading pharmaceutical company in the...
-
Montreal, Quebec, Canada Pharmascience Full timeThe Regulatory Affairs Specialist, Chemistry and Manufacturing plays a vital role within the department to ensure timely and compliant product maintenance and participates in various regulatory projects with corporate partners in Europe.Job OverviewAssumes responsibility for maintaining regulatory compliance for approved products, including prescription and...
-
Regulatory Counsel or Director, Legal Affairs
6 months ago
Montreal, Canada PSP Investments Full timeEXPERIENCE THE EDGE At PSP, we encourage our employees to grow, forge powerful relationships, contribute and fuel inspired investment launchpads. We are committed to a culture that fosters collaboration and allows us to think beyond, in an interconnected way. We advocate for our employees to speak-up, learn, experiment, share, and be part of an where...
-
Montreal, Quebec, Canada Pharmascience Full timeThe Regulatory Affairs Specialist assumes key responsibilities to ensure timely and compliant maintenance of products and participates in various regulatory projects with corporate partners in Europe.Key Responsibilities:Responsible for the maintenance and regulatory compliance for approved products for prescription and OTC drugs, natural health products,...
-
Specialist CMC, Regulatory Affairs
4 weeks ago
Montreal, Canada Pharmascience Inc. Full timeSpecialist CMC, Regulatory Affairs - 6 month contract Job Category: Regulatory Affairs Posted: September 27, 2024 Full-Time Locations Showing 1 location The Specialist, Regulatory Affairs assumes responsibilities within the department to ensure the timely and compliant maintenance of products and participates in various regulatory projects with corporate...
-
Montreal, Quebec, Canada Pharmascience Full timeThe Regulatory Affairs Specialist, Chemistry and Manufacturing assumes responsibilities within the department to ensure the timely and compliant maintenance of products. The position participates in various regulatory projects with corporate partners in Europe.Key Responsibilities:Maintains and ensures regulatory compliance for approved products, including...
-
Montreal, Quebec, Canada Pharmascience Full timeJob DescriptionThe Regulatory Affairs Specialist, Chemistry and Manufacturing assumes key responsibilities within the department to ensure timely and compliant product maintenance. This role participates in various regulatory projects with corporate partners across Europe.Key Responsibilities:Maintains and ensures regulatory compliance for approved...
-
Montreal, Canada Innovaderm Research Full timeDue to ongoing global expansion, Innovaderm is looking to hire a Regulatory Affairs Specialist. In this position, you will be responsible for overseeing central Ethics Committee (EC), Regulatory Authority (RA), and other submissions created within or outside of the company to ensure submissions comply with applicable regulations and guidance documents and...
-
Montreal, Canada Innovaderm Research Full timeDue to ongoing global expansion, Innovaderm is looking to hire a Regulatory Affairs Specialist. In this position, you will be responsible for overseeing central Ethics Committee (EC), Regulatory Authority (RA), and other submissions created within or outside of the company to ensure submissions comply with applicable regulations and guidance documents and...
-
Regulatory Affairs Specialist
4 weeks ago
Montreal, Quebec, Canada NBC Full timeAbout the RoleThis position is responsible for ensuring the application of compliance policies and regulatory requirements in the sectors supported by the team. The ideal candidate will have a strong understanding of regulatory matters and be able to influence the compliance culture within the organization.Key responsibilities include:Ensuring the...
-
Montreal, Canada Pfizer Full timeROLE SUMMARY The Clinician, Clinical Scientist (CS) will provide leadership in clinical epidemiological study execution ensuring consistency of approach, conduct, result reporting and oversight of core team activities within one or more specialty or primary asset programs. In collaboration with Scientific Affairs (SA) Biostatistics group and Clinical...
-
Regulatory Compliance Specialist
2 weeks ago
Montreal, Quebec, Canada Knight Therapeutics Full timeJob DescriptionWe are seeking an experienced Regulatory Affairs Project Manager to join our team at Knight Therapeutics. This role will be responsible for supporting timely filing and approval of submissions, maintenance and compliance of files for drugs and biologics in Canada.Key Responsibilities:Manage regulatory submission/review process according to...
-
Regulatory Affairs Specialist
2 weeks ago
Montreal, Quebec, Canada Novartis Full timeAbout the Role:The Regulatory Affairs Specialist - Pharmacovigilance will support the management of patient safety operational processes in Canada, ensuring compliance with Novartis global and local procedures, national and international regulations/standards/guidelines for vigilance of both marketed and investigational products (including drugs and medical...
