Regulatory Affairs Associate

1 day ago Be among the first 25 applicantsYour New Company At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them. No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team Whether you\'re a recent college graduate or seeking your next career opportunity, it\'s time to discover your future at Altasciences.About The Role The Regulatory Affairs Associate is responsible for preparing and submitting clinical trial applications with Health Canada's TPD, NHPD, and BGTD.What You'll Do HerePreparing, reviewing and submitting CTAs for small molecules, biologics and natural health products to Health Canada's Directorates (TPD, BGTD, NHPD)Company contact and regulatory liaison with Health CanadaAnalyses the information provided by the sponsor and prepares a complete file showing the relevant information to the regulatory bodyOversight and/or preparation of all responses to all Health Canada clarifications requestsPerforms the needed follow-ups to insure that the regulatory requirements needed to start a study are metMaintenance of submission (CTA-A, notification, cancellation)Responsible for assigned study submissions to the IRB, including interactions, answering to clarifications when needed, and ensuring IRB requirements are met prior to protocol implementationPreparing and submitting exemption application for controlled substancesMaintains a database for regulatory submissions and related questionsResponsible for submission/maintenance of annual clinical documents to IRBMay provide regulatory support for drugs, biological products, medical devices, 505b2 program, IND requirements and regulatory documentation (such as CTD/NeeS/eCTD format requirements)May participates to drug development files to be submitted to the regulatory bodies (ex.: pre-IND, IND, pre-CTA)May communicates with Health Canada to insure the feasibility and filing requirements of clinic trials requests on the regulatory levelMaintain current awareness on regulatory guidelines (such as Health Canada\'s TPD, NHPD, and BGTD, FDA) and ensure processes are adjusted as necessaryUndertake continuous learning and development on regulations through self-training, workshops and conferencesPresent details of workshops/courses attended or new knowledge acquiredPrioritize own work and manage project schedule to meet delivery deadlinesRepresents Algorithme Pharma in scientific meetings/exhibitions or business meetingsWhat You'll Need To SucceedBachelor\'s degree in Life SciencesStrong interpersonal skillsGood verbal and written communication skillsProfessional attitudeAttention to detail and accuracyAbility to work with a multi-disciplinary team of professionalsUnderstanding of clinical research, drug development process, and applicable regulatory guidelinesGood computer skills (Microsoft Word, Excel, and Power Point)Altasciences Strives To Provide a French Work Environment For Its Employees In Quebec. Altasciences Has Taken All Reasonable Steps To Avoid Imposing The Above Language Requirement Other Than French. This Requirement Is Essential For The Position Of Regulatory Affairs Associate, But Not Limited To, The Following Reason(s)The employee frequently communicates with Altasciences employees across Canada and the United States. As such, English is the primary language used to correspond between offices.The employee frequently communicates with English-only customers outside the province of Quebec.What We OfferAltasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.Altasciences\' Benefits Package IncludesHealth/Dental/Vision Insurance Plans401(k)/RRSP with Employer MatchPaid Vacation and HolidaysPaid Sick and Bereavement LeaveEmployee Assistance & Telehealth ProgramsAltasciences\' Incentive Programs IncludeTraining & Development ProgramsEmployee Referral Bonus ProgramAnnual Performance ReviewEqual Opportunity Altasciences is an equal opportunity employer committed to diversity and inclusion. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation. Reasonable accommodations for persons with disabilities during the recruitment process are available upon request. Join us at AltasciencesSeniority level Entry levelEmployment type Full-timeJob function LegalIndustries Research Services #J-18808-Ljbffr