Sr Reg Affairs Spec

hace 3 días

Desde casa, México 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 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

  • Sr Reg Affairs Spec

    hace 4 semanas

    Desde casa, México Thermo Fisher Scientific A tiempo completo

    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 to achieve individual career goals while taking science a step beyond through...

  • Sr Reg Affairs Specialist

    hace 3 semanas

    Desde casa, México Thermo Fisher Scientific A tiempo completo

    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 to achieve individual career goals while taking science a step beyond through...

  • Senior Reg Affairs Specialist

    hace 2 semanas

    Desde casa, México Thermo Fisher Scientific A tiempo completo

    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 to achieve individual career goals while taking science a step beyond through...

  • Reg Affairs Spec

    hace 3 semanas

    Desde casa, México Thermo Fisher Scientific A tiempo completo

    Supports the preparation of documentation and submissions under guidance - 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 - Assists with project budgeting/forecasting - Maintains knowledge and...

  • Prin Reg Affairs Assistant

    hace 3 semanas

    Desde casa, México Thermo Fisher Scientific A tiempo completo

    Summarized Purpose: Provides advanced administrative support to the department and supports reporting of such to upper management. Essential Functions - Track each regulatory submission in required tracker system (PPD or sponsor), (Veeva, eTMF, Activate, CTMS). - Review Sharepoint to ensure correct regulatory information is captured as per the tracked...

  • Prin Reg Affairs Assistant

    hace 2 semanas

    Desde casa, México Thermo Fisher Scientific A tiempo completo

    Summarized Purpose:Provides advanced administrative support to the department and supports reporting of such to upper management.Essential Functions Track each regulatory submission in required tracker system (PPD or sponsor), (Veeva, eTMF, Activate, CTMS). Review Sharepoint to ensure correct regulatory information is captured as per the tracked documents....

  • Cfsp Reg

    hace 3 semanas

    Desde casa, México IQVIA A tiempo completo

    Job Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. Essential Functions - Under general supervision, serve as...

  • Sr Training Spec

    hace 2 semanas

    Desde casa, México Thermo Fisher Scientific A tiempo completo

    Discover Impactful Work:You will design and develop effective training solutions to create the desired measurable business outcomes to improve performance and quality of our teams.A day in the Life:You will proactively collaborate to develop and deliver learning solutions that achieve positive business outcomes and industry compliance. You support and...

  • Sr Training Spec

    hace 3 semanas

    Desde casa, México Thermo Fisher Scientific A tiempo completo

    **Discover Impactful Work**: You will design and develop effective training solutions to create the desired measurable business outcomes to improve performance and quality of our teams. **A day in the Life**: You will proactively collaborate to develop and deliver learning solutions that achieve positive business outcomes and industry compliance. You...

  • Clinical Trial Reg Affairs Snr Assistant

    hace 2 semanas

    Desde casa, México Thermo Fisher Scientific A tiempo completo

    Coordinates timely collection of data, metrics, experience statements for proposal and budget development in response to Request for Propoals (RFPs). - Supports bids and proposals; generates, tracks and analyzes data for proposal, revisions, contract modicifcations and bid defenses. - Supports department management in reporting financial, contractual and...

  • Clinical Trial Reg Affairs Specialist Ii

    hace 2 meses

    Desde casa, México Thermo Fisher Scientific A tiempo completo

    Act as an administrator for our in-house Regulatory Intelligence database and provide customer support for issues arising. - Regulatory collaboration with Regulatory Intelligence database workflow users to drive quarterly EQR metrics. - Contribute to a wide range of technical Regulatory Intelligence database content projects including engineering and...

  • Sr. Software Developer

    hace 3 semanas

    Desde casa, México Integon Service Co. A tiempo completo

    OUR COMPANY: Integon Service Co. supports its insurance company affiliates, which offer property and casualty insurance products, including personal auto, homeowners, RV, motorcycle, small business auto insurance and more. With our Mexico headquarters located in Tijuana, Baja California, at Integon, with over 1000 employees, we continue to grow our...