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Sr Reg Affairs Spec at Thermo Fisher Scientific

extra holidays - extra parental leave

Remote:

Full Remote

Contract:

Full time

Salary:

10 - 10K yearly

Experience:

Senior (5-10 years)

Work from:

Mexico

Offer summary

Qualifications:

Bachelor's degree or equivalent qualification, 5+ years of relevant experience, Regulatory affairs experience preferred, Familiarity with global regulatory processes, Experience in clinical trials submissions advantageous.

Key responsabilities:

Lead communication with regulatory agencies
Provide regulatory affairs strategy leadership
Assess and prepare global regulatory submissions
Collaborate with project teams on submissions
Advise project teams on regulatory responsibilities

Thermo Fisher Scientific Biotech: Biology + Technology Large https://www.thermofisher.com/

10001 Employees

HQ: Waltham

See more Thermo Fisher Scientific offers

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

In this role as a Sr Regulatory Affairs Specialist, you will be part of our Regulatory Liaison team, leading on communications with regulatory agencies as part of centralized regulatory submissions including but not limited to the EU CTR process. You will partner with our Regulatory Affairs leads, in providing regulatory affairs strategy technical/project leadership on a regional/global level

Sr Regulatory Affairs Specialist

Provides regulatory advice and carries out projects in the provision of regulatory affairs services:
Acts as liaison with internal team members in the provision of these services.
Works with the Regulatory Affairs Management to perform the day to day operational aspects of the Department such as: assessment of regulatory documents, preparation and assembly of global regulatory submissions, QC review of the final submission package.
Collaborate with PPD project teams and Health Authorities regarding regulatory strategy/submission activities.
Develops and maintains a collaborative working relationship with Project Managers and project team members for assigned projects.
Advises and directs project team as to their responsibilities relative to regulatory strategy/submission activities.
Acts as a key liaison between Regulatory Affairs Department and project team for assigned projects.

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years)

Knowledge, Skills and Abilities:

Some regulatory affairs experience is preferable but not required
An appreciation of the requirements, timelines and processes for regulatory applications globally is a valuable asset.
Previous experience with clinical trials application compilation and submissions in EU and other countries is an advantage.
Excellent English language interpersonal skills, both verbal and in writing.
Digital literacy (Microsoft office) and experience in applications used in clinical trials (eTMF, CTMS) would be an advantage
Good organizational and planning skills. Ability for multiple project tasking
Proven track record to work optimally in a team, including in a multinational one
Problem solving skills and strong attention to detail

Working Conditions and Environment:

 Work is performed in an office environment with exposure to electrical office equipment.

 Occasional drives to site locations with occasional travel both domestic and international