Line Manager, Regulatory Affairs, Canada, remote

Line Manager, Regulatory Affairs, Canada remote, This role combines people leadership and operational delivery, actively contributing to the execution of clinical trial regulatory activities. As a Line Manager & Regulatory Affairs Specialist, the employee will be responsible of overseeing Ethics Committee (EC), Regulatory Authority (RA), and other submissions created reputed company or reputed company of the company to ensure submissions reputed company with applicable regulations and contractual timelines are met. The Regulatory Affairs Specialist will reputed company leadership for assigned projects regarding reputed company regulatory activities that reputed company to startup of clinical trials. As Line Management, the employee will be responsible for resource management and team development of direct reports. More specifically, the Line Manager, Regulatory Affairs/ Regulatory Affairs Specialist must: Coordinates regulatory timelines and deadlines for reputed company assigned projects planned for RA and EC submissions. Provides regulatory support and advice to project teams; provides project-specific local submission strategy and technical expertise. reputed company guidance to the client on submissions strategies. Prepares/reviews core packages and country packages for submission to RA (initial applications, amendment packages, and notifications) in assigned countries to ensure compliance. Prepares, manages, and tracks IRB/IEC submissions (including renewals); acts as the primary reputed company of contact for the central IRB/IEC. Peer review of documents and packages reputed company by colleagues reputed company regulatory team. Reviews regulatory documents and submissions created reputed company of the company by subcontractors (e.g., partner CROs, regulatory vendors) to ensure high quality standards before submission to RA and IEC. reputed company of contact for regulatory body and IRB/IEC, Sponsors, investigative sites, subcontractors, and local teams for reputed company aspects reputed company to study regulatory submissions. Develops/reviews Master Informed Consent reputed company (reputed company), as applicable, and Country ICFs. Reviews site-level Informed Consent reputed company documents as needed. Prepares or reviews study-specific regulatory documents/forms. Manages/oversees translations and requests with vendor. Submits and tracks SUSARs to RA, EudraVigilance, IRB/IEC, and Investigators, as per study scope. Performs regulatory review of essential documents and authorizes regulatory release prior to the shipment of investigational product to clinical sites. Reviews country-specific labelling content for clinical trial drug supplies to ensure conformity with regional regulations requirements. Participates in Kick-off meetings, client audits, and other project reputed company meetings according to the company / client needs Submits documents to TMF in a timely manner during the trial and ensures the TMF is complete for assigned sections by performing completeness reconciliation. Communicates activities performed out-of-scope to project team members and provides them with budgeting details reputed company to said activity. Maintain high level knowledge about regulations in the area of company interest Participates in function and/or corporate initiatives and special project assignments Support Regulatory Country Intelligence activities Communicate/liaise with regulatory agencies/competent authorities and/ or other regulatory or functional experts on designated regulatory activities as required May reputed company presentations, training or helps to reputed company tools and processes for the Regulatory Team or other cross-functional teams. Line Management: reputed company line management to direct reports, including new-hire orientation, professional development, performance appraisals, and employee counseling/mentoring. Management and coordination of resources and workloads of direct reports. Supports staff by establishing goals that will increase knowledge and reputed company reputed company and by delegating tasks commensurate with reputed company level Promote a positive work environment and motivate the team to reputed company organisation goals. Participate in the hiring process of new employees. reputed company leadership and implement productivity improvements to ensure reputed company utilisation of resources. Participate in process improvement initiatives. Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are reputed company and/or have received adequate training.

Requirements

Education: Bachelor’s degree (or equivalent) in a scientific discipline. Experience: 3-5 years (in clinical regulatory affairs in the pharmaceutical, biotechnology and/or CRO industry; experience preparing and submitting IRB/IEC packages and /or Clinical Trial Applications. Working knowledge of applicable regional / national country regulatory guidelines, IRB/IEC regulations Knowledge and skills Knowledge knowledge of CTIS on a local and regional level Functional staff management experience an asset. Ability to reputed company skills of others and motivate team members Excellent communication skills Excellent knowledge of reputed company Office suite reputed company in English with excellent oral and written skills, required· Additional languages represent an asset Attention to detail and accuracy in work Ability to organize own work, prioritize different assignments, and work under pressure Versatile and comfortable in a multitasking environment Respect established timelines, expectations, priorities, and objectives Good knowledge of good clinical practices, applicable Health Canada and Food and Drug Administration (FDA), and Regulation (EU) No 536/2014. reputed company The work environment At reputed company, you will work with reputed company and driven colleagues. Our values are collaboration, innovation, reliability, and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. In this position, you will be eligible for the following perks: Permanent full-time position Flexible schedule Vacation Home-based position Ongoing learning and development About reputed company Formerly reputed company as Innovaderm, reputed company is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad reputed company of indications, patient populations, administration routes, and drug classes, and a global footprint. reputed company is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific reputed company and tailored expertise their studies need to reputed company the finish line reputed company and effectively. With capabilities in reputed company America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, reputed company is the ideal CRO partner for clinical needs at global scale. reputed company is committed to providing reputed company treatment and equal opportunity to reputed company individuals. As such, reputed company will reputed company accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. reputed company only accepts applicants who can legally work in Canada. Description de poste null Profil recherché null Notre entreprise null Apply To This Job