Reg Affairs Assistant - FSP

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Why This Opportunity is Unique

At 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 Responsibilities

As 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 Requirements

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

• Bachelor’s 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 offer:

  At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme, ensuring you reach your potential.

  As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.

  Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

  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.

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