Sr. Regulatory Affairs Specialist

hace 13 horas

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 most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing - whatever your ambitions.

**Your Responsibilities will Include**
- Develop local strategies for regulatory approval in collaboration with Marketing, Planning, and International Division teams.
- Coordinate, compile, and submit regulatory filings for new and modified products to DIGEMID.
- Coordinate, compile, and prepare regulatory documentation for Tenders purposes.
- Review product and manufacturing changes for compliance with applicable regulations and assess the impact on regulatory filings.
- Coordinate the localization process to ensure compliance with Peru´s labeling requirements.
- Review promotional materials.
- Represent Regulatory Affairs on cross-functional projects, providing regulatory feedback and guidance, including involvement in process changes, continuous improvement efforts, and acceleration towards digital transformation.
- Foster positive relationships with regulatory agencies and industry associations through verbal and written communications, acting as the focal point for regulatory advocacy in Peru.
- Ensure that the quality assurance system in the stages of reception, storage, and distribution guarantees the conservation, stability, and quality of pharmaceutical products, medical devices, and health products, and for controlled products, their custody.
- Control that the commercialization of products is carried out exclusively to pharmaceutical establishments, commercial establishments, or the final consumer, as appropriate.
- Order the withdrawal from the market of products or devices from batches, series, or identification codes, when necessary, and communicate the fact, when appropriate, to the National Authority of Pharmaceutical Products, Medical Devices, and Health Products (ANM), the decentralized body of the national health authority (OD), or the corresponding Regional Health Authority (ARS) through the Regional Authority of Pharmaceutical Products, Medical Devices, and Health Products (ARM). Authorize the marketing of products or devices after verifying their compliance with the specifications approved in the sanitary registration.
- Verify that there are no contaminated, adulterated, falsified, altered, expired products or devices in poor condition or other sanitary observations. If this is the case, they will be withdrawn from sale and placed in the low area or rejected, duly identified and sealed for subsequent destruction. In the case of allegedly falsified products or devices, this situation must be communicated to the National Authority of Pharmaceutical Products, Medical Devices, and Health Products (ANM) or the corresponding Regional Health Authority (ARS) through the Regional Authority of Pharmaceutical Products, Medical Devices, and Health Products (ARM).
- Verify that official books or electronic data records are kept up to date and remain in the establishment.
- Train and supervise assistant and technical staff in the correct performance of their duties.
- Ensure the accuracy of the statements, documentation, and information submitted to request the Sanitary Registration or its modification.
- Notify suspected adverse reactions and adverse incidents of pharmaceutical products, medical devices, or health products, in the authorized format in physical or electronic form validated and within the deadlines established in local regulations if stricter than BSC.
- Develop and maintain a database for recording adverse reactions and incidents.
- Maintain the confidentiality of notifications of suspected adverse reactions and adverse incidents.
- Report to the National Authority of Pharmaceutical Products, Medical Devices, and Health Products (ANM) the quality control analysis protocols or quality control test reports of the batches entering the market, as established by local regulations.
- Custody the technical documentation related to the products or devices marketed.
- Comply with and enforce Good Storage Practices and Good Distribution and Transportation Practices and, where appropriate, Good Pharmacovigilance Practices.
- Verify that the promotion and advertising produced and disseminated in drugstores comply with current regulations.
- Verify compliance with local health regulations.
- Approve, custody, and keep updated all technical documentation concerning the Sanitary Registration of the medical devices entrusted for reconditioning.
- Ensure the accuracy of the statements, documentation, and information submitted to

  • Regulatory Affairs Specialist

    hace 5 días

    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...

  • 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 completo

    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 regulatory affairs responsibilities, leading discussions, and...

  • Associate Regulatory Affairs Specialist

    hace 6 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 Project Management Specialist

    hace 1 semana

    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...

  • 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 Specialist

    hace 4 semanas

    Lima, Perú Thermo Fisher Scientific A tiempo completo

    **Work 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,...

  • Sr Reg 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 Jr Specialist

    hace 1 semana

    Lima, Perú Johnson & Johnson A tiempo completo

    En 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 Intern

    hace 3 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...

  • 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...

  • Regulatory Affairs Manager

    hace 3 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...

  • Principal Reg Affairs Spec

    hace 7 meses

    Lima, Perú Thermo Fisher Scientific A tiempo completo

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office We are currently seeking a Principal 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...

  • (Buen Sueldo) Regulatory Affairs Manager

    hace 1 semana

    Lima Metropolitana, Perú Thermo Fisher Scientific A tiempo completo

    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 deliverables meet current local, regional, and ICH regulatory and technical...

  • Regulatory Affairs Strategist

    hace 3 semanas

    Lima, Perú Tether Operations Limited A tiempo completo

    Tether 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...

  • Regulatory Compliance Specialist

    hace 3 semanas

    Lima, Perú Thermo Fisher Scientific A tiempo completo

    At Thermo Fisher Scientific, we offer a competitive remuneration package, including an annual incentive plan bonus, healthcare benefits, and a range of employee perks. Our innovative organization is built on a foundation of integrity, intensity, involvement, and innovation.We are seeking a skilled Regulatory Compliance Specialist to join our team. This role...

  • (Quedan 3 Días) Regulatory Affairs Manager

    hace 2 semanas

    Lima Metropolitana, Perú Thermo Fisher Scientific A tiempo completo

    Work 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...

  • Thermo Fisher Scientific | Regulatory Affairs Manager

    hace 2 semanas

    lima, Perú Thermo Fisher Scientific A tiempo completo

    Work 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...

  • Communication and External Affairs Specialist

    hace 3 meses

    Lima Metropolitana, Perú First Quantum Minerals Ltd. A tiempo completo

    The career you're looking for starts here. Find the role that will give you challenges and opportunities. If you are one of our employees who is interested in a job advertised on this website, then we encourage you to find out more and apply here. Communication and External Affairs Specialist At First Quantum, we free the talent of our people by taking a...

  • Communication and External Affairs Specialist

    hace 4 semanas

    Lima, Perú First Quantum Minerals Ltd. A tiempo completo

    At First Quantum, we free the talent of our people by taking a very different approach which is underpinned by a very different, very definite culture – the “First Quantum Way”. Working with us is not like working anywhere else, which is why we recruit people who will take a bolder, smarter approach to spot opportunities, solve problems and deliver...