Clinical Research Regulatory Affairs Associate

By | February 5, 2025

Clinical Research Regulatory Affairs Associate

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Job ID: 9687796

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Philadelphia, PA, US

Scientific

Unspecified

Full Time, Temporary

DOE (commensurate with experience)

Experienced (Non-Manager)

On-site

Biotechnology/Pharmaceuticals

First Shift (Day)

Philadelphia, PA, US

DOE (commensurate with experience)

Experienced (Non-Manager)

Full Time, Temporary

Biotechnology/Pharmaceuticals

On-site

Scientific

Unspecified

First Shift (Day)

Apply Now Applied

Job details

PLEASE NOTE: Must be authorized to work lawfully in the United States for any employer without sponsorship. For immediate consideration, please apply.

Kelly® Science & Clinical is seeking a Clinical Research Regulatory Affairs Associate for temporary, temporary-to-hire, and direct hire positions at a leading client in Philadelphia, PA. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Pay Rate: 
DOE (commensurate with experience)

Overview:
Our client is seeking a dedicated and detail-oriented Clinical Research Regulatory Affairs Associate to join their dynamic team. This position offers a unique opportunity to play a crucial role in the regulatory aspects of clinical research, ensuring compliance with all applicable regulations and guidelines. If you have a keen eye for detail and a passion for clinical research, we would love to hear from you!

Schedule:
Monday – Friday, 1st/Day: Standard Hours

Responsibilities:
•    Prepare and submit regulatory documents to regulatory authorities in a timely manner.
•    Maintain up-to-date knowledge of regulatory requirements and ensure compliance with all applicable regulations and guidelines.
•    Coordinate with clinical project teams to ensure all regulatory documentation is complete and accurate.
•    Assist in the development and implementation of regulatory strategies for clinical trials.
•    Monitor and track the progress of regulatory submissions and provide updates to project teams.
•    Communicate with regulatory agencies and respond to inquiries in a timely manner.
•    Maintain and organize regulatory files and databases.
•    Provide regulatory support during audits and inspections.

Qualifications:
•    Bachelor’s degree in Life Sciences, Pharmacy, or a related field.
•    Minimum of 2 years of experience in regulatory affairs within the clinical research industry.
•    Strong knowledge of regulatory requirements and guidelines (e.g., FDA, EMA).
•    Excellent written and verbal communication skills.
•    Strong organizational and time management skills.
•    Ability to work independently and as part of a team.
•    Attention to detail and a high level of accuracy.

What Happens Next:
Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.

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