Reg Affairs Assistant
Remote, India
Job Id: R-01276364
Job Type: Full time
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
We 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.