Sr Reg Affairs Spec

hace 3 semanas

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 solutions and global regulatory expertise, being client interfacing to provide strategic regulatory intelligence and guidance.

You will feel confident providing regulatory advice and carry out projects in the provision of regulatory affairs services whilst acting as liaison with internal and external clients.

You will act as a representative of the regulatory department with other departments, supporting business development, working on initiatives, and contributing to quality improvement. You will also arrange, lead, and report on client and regulatory agency meetings.

The following skills are required to be successful in this position:

- preparation and assembly of global regulatory submissions
- interacting with sponsors,
- review and assess clinical trial regulatory documents,
- review and assess scientific literature.
- manages project teams and preparation
- participate in launch meetings, review meetings and project team meetings.

Optional skills:

- Experience with bid defense meetings

**Qualifications - External**

What the role requires you to have:

- Bachelor's degree or advanced degree preferred, or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job
- Knowledge of the global clinical trials landscape

Knowledge, Skills and Abilities:

- Excellent command of the English language (written and oral) as well as local language where applicable
- Excellent attention to detail and quality as well as excellent editorial/proofreading skills
- Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments
- Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies
- Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
- Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables
- Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization; expert knowledge of ICH and other global regulatory guidelines
- Excellent analytical, investigative and problem-solving skills

  • Principal Reg Affairs Spec

    hace 3 semanas

    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...

  • Reg Affairs Spec

    hace 3 semanas

    Lima, Perú Thermo Fisher Scientific A tiempo completo

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office The following skills are required to be successful in this position: - preparation and assembly of global regulatory submissions - interacting with sponsors, - review and assess clinical trial regulatory documents, - review and assess scientific literature. - manages project teams...

  • Sr Reg Affairs Specialist

    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...

  • Reg 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...

  • Reg Affairs

    hace 3 semanas

    Lima, Perú Diversey, Inc. A tiempo completo

    Directora Tecnica y responsable del aseguramiento de la calidad en Perú. - Presentar los permisos legales antes los organismos, para sus aprobaciones. - Garantizar la calidad de los procesos y de los productos. - Hacer seguimiento a rechazos y devoluciones por temas de calidad del producto. - Representar a Diversey, como directora técnica, ante organismos...

  • Sr. Regulatory Affairs Specialist

    hace 3 semanas

    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...

  • Sr Director, Project Management

    hace 4 semanas

    Lima, Perú Thermo Fisher Scientific A tiempo completo

    At PPD, a Division of Thermo Fisher Scientific, our mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our...

  • Sr. Spclst, Clinical Research

    hace 3 semanas

    Lima, Perú MSD A tiempo completo

    **Responsibilities include, but are not limited to**: - Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. - Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. -...

  • Sr/principal Operational Quality and Compliance Specialist

    hace 4 semanas

    Lima, Perú Thermo Fisher Scientific A tiempo completo

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed...

  • Associate Cra

    hace 3 semanas

    Lima, Perú MSD A tiempo completo

    **Job Description**: We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that...