Job Description

Work Schedule Standard (Mon-Fri)Environmental Conditions OfficeWhy This Opportunity is UniqueAt PPD Clinical Research Services, Thermo Fisher Scientific, we pride ourselves on our commitment to excellence and innovation. As a Regulatory Affairs Assistant, you will play a pivotal role in Provides administrative support to the department, including management and maintenance of regulatory
documents, tools, and websites.. This is an exceptional opportunity to work within a world-class team dedicated to delivering flawless solutions and shaping the future of healthcare.Job ResponsibilitiesAs a Regulatory Affairs Assistant, you will be entrusted with a variety of responsibilities to ensure compliance and effectiveness in our regulatory processes. Your key duties will include:

• Provides administrative support to regulatory staff for filing & tracking of documents.
• Responds to regulatory staff requests for administrative support as needed.
• Sets up and maintain files, prepares reports, takes minutes during team meetings.
• Updating the regulatory systems for submission performed to health authorities.
• Generating the status reports for regulatory applications
• Coordinating and communicating with internal teams to gather necessary information to up to date the regulatory database and systems.
• Ensuring timely and accurate update of regulatory information management systems.
• Supporting and assisting the regulatory affairs team for the global submissions.

Job RequirementsTo be successful in this role, you should possess the following qualifications and skills:

• Bachelor\xe2\x80\x99s degree or equivalent experience in Life Sciences, Pharmacy, or a related field.
• Experience in regulatory affairs is preferred.
• Basic knowledge of regulatory guidelines and regulatory submission processes.
• Excellent communication and interpersonal skills.
• Ability to adhere to deadlines and manage multiple tasks simultaneously.

What We OfferWe believe that our employees are our greatest asset, and we aim to provide a supportive and inclusive work environment. At Thermo Fisher Scientific Inc., you will get:

• Opportunities for professional development and career growth.
• A collaborative and inclusive culture where you can thrive.
• The chance to work on ambitious projects that have a real impact on global health.

Thermo Fisher Scientific