EU Regulatory Assistant and Systems Administrator in Lyon, France

Job Description

As part of the Thermofisher Scientific’s Pharmaceutical Service Group (PSG) European Regulatory Affairs (EU RA) team and reporting to a regional lead, you will discover meaningful work that makes a positive impact at a regional regulatory scale. Our focus is to contribute to our EU sites regulatory compliance and deliver “state of art” regulatory services to exceed our Customers’ expectation

Join us and get the opportunity to develop yourself as a regulatory professional through exposure to exciting challenges in an innovative and evolving environment while interacting with multiple functions

How will you make an impact ?

As a member of our regulatory regional team:

You will assist leaders as well as our regulatory matrix talents while scheduling, coordinating, handling key activities and collaborating to special programs

You will also look after our digital platforms , address team members’ needs, sponsor improvements and process implementation.

Through both core aspects of your job, you will take part in the performance and visibility of our “one” regulatory function

A day in the Life

Regional Team Assistance

Plan, prepare, post and communicate on key deliverables, handle execution of assigned ones per defined timelines and manage semester schedule updates

Participate in regional and global initiatives by addressing administrative and/or technical activities (decks, minutes, actions / project trackers, surveys etc…)

Coordinate logistical aspects of regional leads travels, team meetings, regulatory events and proceed with all arrangements (travel bookings, catering, lodging, meeting rooms & set-ups…)

Manage regional leadership team calendars (business trips and vacations)

Handle budget control (monthly checks) and engage in annual budget proposal crafting

Process regional team’s subscriptions, trainings & congresses bookings and all expenses reports

Provide a hand on general administrative tasks (prints, scans, binders, archives, stationary orders…)

Systems administration

Develop, optimize and maintain the global regulatory reporting platform (data entry) to support our metrics

Coordinate regulatory reporting including template issuance, data pooling, report assembly

Administer several global and regional digital collaborative platforms (access control & data uploading) and provide operational technical assistance as needed

Sponsor simplification and continuous improvement of existing platforms and tools and implement per plan

Perform regular systems audits and drive remediation action plan

Develop and lifecycle job aids applicable to our platforms, and best practices (work instructions, questions & answers…)

Prepare and deliver trainings to new comers and to address collaborators’ needs for harmonized community’s practices

Set-up back-ups for key activities, elaborate plans as needed and deliver required trainings to ensure business continuity

Complexity of the Job

You will report to a regional lead and collaborate with around 40 people within our European matrix, as well as with our North American counterparts

You will also partner with various functions (Quality, IT, Finance etc…) and at various managerial levels within our PSG organization

You will administer around 5 to 10 collaborative platforms supporting our regulatory business

You will evolve in a fast-paced environment with the aim to always challenge the “status quo” and find better ways to improve the team’s performance

Education

High school graduation required with a minimum of 2+ years of undergraduate studies (BTS, B.Sc or equivalent)

Experience

Related experience in a pharmaceutical industry environment , preferably in the regulatory or quality field

Requires minimum 5/7 years of proven experience in administrative or technical support or equivalent

Knowledge, Skills, Abilities

· Strong communication and interpersonal skills, enabling effective interactions with all levels

· Focused individual with attention to details and data accuracy

· Ability to stay organized and multi-task in a professional and efficient manner to meet strict

deadlines

· Well versed in working autonomously

· Exhibit proactivity, self-motivation, and flexibility to adapt to new business needs

· IT expertise – MS office applications (Outlook, Excel, Word, PowerPoint) in particular with Excell and collaborative platforms (SharePoint, Teams)

Language: fluent in English (written + spoken), to smoothly handle exchanges ( > 80% in English), and welcoming proficiency in a second language

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.