Principal Regulatory Affairs Specialist - Regulatory Liaison
Free to start · No card · 5 credits the moment you sign up
Job description
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob 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.
Principal Regulatory Affairs Specialist
- 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:
- Some regulatory affairs experience is preferable but not mandatory
- 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
Originally posted on Himalayas
Prepare your application
Use the description above to assess your fit for 200510503Z Thermo Fisher Scientific Pte. Ltd.. This checklist is guidance from Resumize, rather than additional requirements from the employer. Imported listings can be shortened or change after collection, so confirm the complete description and current availability before sending an application.
Match requirements to evidence
Identify the responsibilities and skills the employer explicitly names. For each important requirement, choose one example from your work, education, training, or projects. Explain what you did, how you did it, and what changed as a result. Include a measurable outcome when you can support it. If you lack a requirement, describe related experience accurately instead of adding an unfamiliar skill to your resume.
Put the most relevant examples near the top of your resume. Keep job titles, dates, qualifications, and contact details consistent across your application materials. Use the employer’s terminology when it describes your experience accurately; a copied list of keywords does not explain your contribution. A short, specific bullet is easier to review than a paragraph that mixes several unrelated duties.
Check the working arrangement
Confirm the location, schedule, employment type, and any eligibility requirements on the employer’s site. A remote label does not establish worldwide eligibility or flexible hours. If compensation, benefits, equipment, travel, or contract duration are missing from this listing, write down your questions for the recruiter. Do not assume details from another opening at the same company apply to this role.
Review before submitting
Follow the employer’s requested file format and application instructions. Open your exported resume and check that its text is selectable, its sections read in order, and its links work. Proofread names, dates, and contact information. Share confidential work samples only when you have permission, and use an anonymized example when necessary.
Submit through a trusted employer or recruiting destination. If the original listing has disappeared, search the employer’s careers page for the title rather than assuming the vacancy remains open. Save the application date, job reference, and the version of your resume you sent. Those details help you prepare for a later conversation and avoid submitting conflicting information through several job boards.
Review your resume for writing and readability feedback, or browse other openings if this opportunity is unavailable.