Sr Reg Affairs Spec - Regulatory Liaison

ThermoFisher Scientific; United States; Remote; USD 100,000 - 150,000; Full time

Job summary

Thermo Fisher Scientific in the United States is seeking a Sr Regulatory Affairs Specialist - Regulatory liaison to support global regulatory submissions and strategy. You will collaborate with internal stakeholders and health authorities to ensure compliant submissions and timely approvals.

Responsibilities include preparing global regulatory documents, QC review of submissions, coordinating with project teams, and advising on regulatory strategy.

Qualifications

• Bachelor's degree in Pharmacy or Life Science required or advantageous.
• Regulatory experience or combination of education and experience considered.
• Strong English communication skills, written and verbal.

Responsibilities

• Provides regulatory advice and carries out projects in regulatory affairs services.
• Acts as liaison with internal stakeholders in regulatory affairs.
• Performs day-to-day operational aspects: assessment of regulatory documents, preparation and assembly of global regulatory submissions, QC review of final submission package.
• Interfaces with project teams and Health Authorities regarding regulatory strategy/submission activities.
• Develops and maintains cooperative working relationships 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.

Skills

Regulatory affairs experience

English communication

Cross-functional collaboration

Attention to detail

Project coordination

Education

Bachelor's degree in Pharmacy or Life Science

Tools

eTMF

CTMS

Microsoft Office

Job description

Work Schedule

Standard Office Hours (40/wk)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

The Sr Regulatory Affairs Specialist - Regulatory liaison:

• Provides regulatory advice and carries out projects in the provision of regulatory affairs services:
• Acts as liaison with internal stakeholders in the provision of these services.
• Works with the Regulatory Affairs Sr 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.
• Interfaces with PPD project teams and Health Authorities regarding regulatory strategy/submission activities.
• Develops and maintains a cooperative 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; degree in Pharmacy or Life Science is an advantage
• Previous regulatory experience, or combination of higher education/less experience or substitution of equivalent relevant work experience will be considered

Knowledge, Skills and Abilities

• Previous Regulatory affairs experience
• 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 communication skills, both verbal and in writing.
• Computer skills (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 ability to work effectively in a team, including in a multinational one
• Problem solving skills and strong attention to detail

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.