Posted a month ago

Job summary

• Job post source

  This job is directly from Thermo Fisher Scientific

• Job overview

  The Senior Regulatory Affairs Specialist at Thermo Fisher Scientific ensures regulatory compliance and supports scientific advancements by managing regulatory strategies and documentation.

• Responsibilities and impact

  The role involves managing project documentation, coordinating regulatory submissions, overseeing financial reviews and budget management, planning project amendments, managing risks and issues, and ensuring system and data accuracy throughout study lifecycles.

• Experience and skills

  Candidates need at least one year as a Study Start-up Trial Manager, experience in project documentation and regulatory compliance, strong financial and budget management skills, proficiency with project management systems like Clarity, EDMS, and eTMF, plus excellent communication and organizational abilities.

• Job location and travel

  The position is remote with a standard Monday to Friday office schedule.

Company overview

Thermo Fisher Scientific is a global leader in serving science, providing innovative technologies, software, and services to customers in various industries including healthcare, pharmaceuticals, and research. They generate revenue through the sale of laboratory equipment, reagents, and consumables, as well as offering contract research and manufacturing services. Founded in 2006 through the merger of Thermo Electron and Fisher Scientific, the company has a rich history of strategic acquisitions to expand its product portfolio and market reach.

How to land this job

• Tailor your resume to highlight your experience in regulatory affairs, especially focusing on document management, regulatory submissions, and compliance to align with Thermo Fisher Scientific's Senior Regulatory Affairs Specialist role.

• Emphasize your skills in financial review and budget management, showcasing your ability to assess scope, forecast units, and contribute to contract modifications as outlined in the job description.

• Apply through multiple channels including Thermo Fisher Scientific's official corporate careers page and LinkedIn to maximize your application visibility and opportunities.

• Connect with current employees in the regulatory affairs or study start-up divisions on LinkedIn; use ice breakers like referencing recent regulatory initiatives Thermo Fisher has announced or asking about their experience with project risk management processes.

• Optimize your resume for ATS by incorporating keywords such as 'document management,' 'regulatory submissions,' 'Clarity,' 'eTMF,' 'EDMS,' 'budget management,' and 'project risk management' to ensure it passes automated screenings effectively.

• Leverage Jennie Johnson's Power Apply feature to automate applying across multiple platforms, tailor your resume with the right keywords, and identify relevant LinkedIn contacts, allowing you to focus your time on meaningful networking and interview preparation.