Principal Regulatory Affairs Assistant
hace 2 meses
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Essential Functions and Other Job Information**:
- Supports the preparation of documentation and submissions of North American IRB and REB submissions
- Coordinates and manages client deliverables supporting regulatory compliance.
- Liaises with internal and external clients in the tracking and status update of project plans and overall support of projects.
- Maintains knowledge and understanding of SOPs, client SOPs/directives, and current regulatory guidelines.
- Evaluates client needs in relationship to overall project timelines, quality and delivery.
- Engages with other project team members, functional units and/or management as necessary to deliver final product, and resolve/mitigate identified issues or barriers to delivery as needed
- Provides project specific services, documentation and coordination of projects and supports reporting of same to management, internal and external clients.
**Education and Experience**:
Excellent organizational and planning skills to effectively manage shifting priorities
- Capable of working effectively on a team and/or independently with mínimal supervision
- Excellent electronic document production skills
- Exceptional attention to detail and quality of documentation
- Outstanding interpersonal skills with the ability to interact with customers
- Excellent verbal and written communication skills
- Capable of multitasking and working under pressure
- First-rate analytical, business and math skills
Bachelor’s degree in pharmacy or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 6 years). Prior experience with US or Canadian ethics committees that provides the knowledge, skills, and abilities to perform the job (comparable to 1+ years)
-
Principal Regulatory Affairs Specialist
hace 8 horas
Lima, Perú PPD A tiempo completo**JOB DESCRIPTION**: Principal Regulatory Affairs Specialist We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD clinical research services — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative...
-
Senior Regulatory Affairs Specialist
hace 7 meses
Lima, Perú Thermo Fisher Scientific A tiempo completo**Work Schedule** Other **Environmental Conditions** Office We are currently seeking a Senior Regulatory Affairs Specialist to join our global Regulatory Affairs department. This is a fantastic opportunity to further develop your regulatory career and expertise in a global clinical trial setting. In this role you will be a pivotal team member with...
-
Senior Regulatory Affairs Specialist
hace 7 meses
Lima, Perú Thermo Fisher Scientific A tiempo completoWe are currently seeking a Senior Regulatory Affairs Specialist to join our global Regulatory Affairs department. This is a fantastic opportunity to further develop your regulatory career and expertise in a global clinical trial setting. In this role you will be a pivotal team member with regulatory affairs responsibilities, leading discussions, and...
-
Regulatory Affairs Specialist
hace 2 semanas
Lima, Perú Johnson & Johnson Family of Companies A tiempo completo**Regulatory affairs specialist**: At Johnson & Johnson, the largest healthcare company in the world, we come together with one purpose: to profoundly change the trajectory of health for humanity. Diversity & Inclusion are essential to continue building our history of groundbreaking and innovation, which has been impacting the health of more than 1 billion...
-
Regulatory Affairs Specialist
hace 2 meses
Lima, Perú Thermo Fisher Scientific A tiempo completo**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office The North American Regulatory Affairs Lead (RAL) provides innovative regulatory solutions and expertise to support product development from preclinical stages through registration and product optimization. This role involves strategic intelligence and guidance, ensuring that client...
-
Regulatory Affairs Intern
hace 4 semanas
Lima, Perú Boston Scientific Corporation A tiempo completo**Work mode**: **Onsite Location(s)**:Lima, LIM, PE **Additional Locations**: N/A **Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance** - At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most...
-
Regulatory Affairs Project Management Specialist
hace 2 semanas
Lima, Perú Johnson & Johnson A tiempo completo**REGULATORY AFFAIRS PROJECT MANAGEMENT SPECIALIST**: At Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1...
-
Associate Regulatory Affairs Specialist
hace 7 meses
Lima, Perú Medtronic A tiempo completo**Careers that Change Lives **In this exciting role as an Associate Regulatory Affairs Specialist, you will be in charge to prepare Regulatory Affairs (RA) meetings (regulatory status) involving cross-functional business partners under your responsibility. To provide status on time about projects and all applicable regulatory activities assigned by Senior...
-
Regulatory Affairs Manager
hace 4 semanas
Lima, Perú Thermo Fisher Scientific A tiempo completo**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office The North American Regulatory Affairs Lead (RAL) provides innovative regulatory solutions and expertise to support product development from preclinical stages through registration and product optimization. This role involves strategic intelligence and guidance, ensuring that client...
-
▷ Buen Sueldo: Regulatory Affairs Specialist
hace 16 horas
Lima Metropolitana, Perú Thermo Fisher Scientific A tiempo completoThe North American Regulatory Affairs Lead (RAL) provides innovative regulatory solutions and expertise to support product development from preclinical stages through registration and product optimization. This role involves strategic intelligence and guidance, ensuring that client deliverables meet current local, regional, and ICH regulatory and technical...
-
(Buen Sueldo) Regulatory Affairs Manager
hace 2 semanas
Lima Metropolitana, Perú Thermo Fisher Scientific A tiempo completoThe North American Regulatory Affairs Lead (RAL) provides innovative regulatory solutions and expertise to support product development from preclinical stages through registration and product optimization. This role involves strategic intelligence and guidance, ensuring that client deliverables meet current local, regional, and ICH regulatory and technical...
-
Regulatory Affairs Jr Specialist
hace 2 semanas
Lima, Perú Johnson & Johnson A tiempo completoEn Johnson & Johnson, la compañía de cuidado de la salud más grande del mundo, nos unimos con un propósito: transformar la historia de la salud en la humanidad._ - La diversidad y la inclusión son esenciales para continuar construyendo nuestra historia de pioneros e innovación, que ha estado impactando la salud de más de mil millones de pacientes y...
-
Regulatory Affairs Strategist
hace 4 semanas
Lima, Perú Tether Operations Limited A tiempo completoTether Operations LimitedPEN 70,000 - 100,000 (estimated)Company Overview: Tether is a pioneering company in the stablecoin and blockchain industry, committed to pushing the boundaries of innovation and technology.About the Role: We are seeking an experienced Regulatory Affairs Strategist to design and execute global regulatory strategies for our biotech...
-
Sr. Regulatory Affairs Specialist
hace 1 semana
Lima, Perú Boston Scientific Corporation A tiempo completo**Work mode**:Hybrid **Onsite Location(s)**:Lima, LIM, PE **Additional Locations**: N/A **Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance** - At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the...
-
Principal Regulatory Affairs Assistant
hace 4 semanas
Lima, Perú Thermo Fisher Scientific A tiempo completo**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Essential Functions and Other Job Information**: - Coordinates timely collection and management of data, metrics, experience statements for proposal and budget development in response to Request for Propoals (RFPs). Supports preperation of bids and proposals; generates, tracks...
-
Principal Regulatory Affairs Assistant
hace 16 horas
Lima Metropolitana, Perú Thermo Fisher Scientific A tiempo completoWork Schedule Standard (Mon-Fri) Environmental Conditions Office Essential Functions and Other Job Information: - Coordinates timely collection and management of data, metrics, experience statements for proposal and budget development in response to Request for Proposals (RFPs). Supports preparation of bids and proposals; generates, tracks and analyzes...
-
(Quedan 3 Días) Regulatory Affairs Manager
hace 3 semanas
Lima Metropolitana, Perú Thermo Fisher Scientific A tiempo completoWork Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description The North American Regulatory Affairs Lead (RAL) provides innovative regulatory solutions and expertise to support product development from preclinical stages through registration and product optimization. This role involves strategic intelligence and guidance, ensuring...
-
Sr Reg Affairs Spec
hace 2 meses
Lima, Perú Thermo Fisher Scientific A tiempo completo**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office In this role you will be a pivotal team member with regulatory affairs responsibilities, leading discussions, and coordinating regulatory strategies globally on assigned (Phase 1 to 4) clinical trials, studies and projects. You will be part of a global team providing innovative...
-
Buen Sueldo! Head of Regulatory Affairs
hace 2 días
Lima Metropolitana, Perú Tether Operations Limited A tiempo completoHead of Regulatory Affairs - Tether Data (Fully Remote, Worldwide) Tether Operations Limited is seeking a visionary Head of Regulatory Affairs to lead our global regulatory strategy for Tether Data. As a key member of our team, you will design and execute regulatory strategies that ensure the company's compliance with national and international...
-
Thermo Fisher Scientific | Regulatory Affairs Manager
hace 3 semanas
lima, Perú Thermo Fisher Scientific A tiempo completoWork Schedule Standard (Mon-Fri)Environmental Conditions OfficeJob Description The North American Regulatory Affairs Lead (RAL) provides innovative regulatory solutions and expertise to support product development from preclinical stages through registration and product optimization. This role involves strategic intelligence and guidance, ensuring that...