JOB DESCRIPTION

In the world of biologics, MedImmune has established itself as a true visionary, with one of the most robust pipelines in the biopharmaceutical industry.

MedImmune is hiring senior level Regulatory Affairs professionals.

This role is responsible for collecting, preparing, and assembling documentation required for Investigational New Drug Applications, Clinical Trial Applications, and Investigational Medicinal Product Dossiers.

You will support cross-functional activities pertaining to regulatory meetings, including development of briefing documents and conduct of meeting rehearsals. You'll be expected to identify potential regulatory issues and recommend solutions to Regulatory Affairs management. You will lead teams in developing regulatory submissions within an assigned product portfolio.

Candidates must have a strong understanding of the drug development and regulatory process.

You should be knowledgeable with general principles of nonclinical development, chemistry and manufacturing, and clinical development.

4 years experience in regulatory affairs with an additional 2 years in biopharmaceuticals are a must.

Join our team and add to MedImmune’s Strength of Integration. Apply online today at www.myjstn.com/MedImmune.

Regulatory Affairs Professionals

MedImmune is looking for Regulatory Affairs Professionals to work in Gaithersburg, MD
Company	MedImmune
Location	Gaithersburg, MD
Type	Full Time
Experience	4-8 years
Job Description:
MedImmune is hiring senior level Regulatory Affairs professionals.
Responsibilities:
This role is responsible for collecting, preparing, and assembling documentation required for Investigational New Drug Applications, Clinical Trial Applications, and Investigational Medicinal Product Dossiers.

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MedImmune Jobs Healthcare TITLE: Regulatory Affairs Professionals

MedImmune Jobs

Regulatory Affairs Professional

MedImmune is hiring regulatory affairs professionals to work full time in Gaithersburg, MD.

In this role, you will collect, prepare, and assemble documentation required for certain tests and applications, as well as lead a team of co-workers to ensure maximum productivity.

We want candidates who have great leadership skills, a strong understanding of the drug process, and have at least 4 years experience in regulatory affairs.

Working as a Regulatory Affairs Professional

As a regulatory affairs professional for MedImmune, you will perform a number of duties relating to drug development and it’s regulatory process. You will collect, prepare, and assemble documentation required for Investigational New Drug Applications, Clinical Trial Applications, and Investigational Medicinal Product Dossiers. Along with these duties, you will be expected to identify potential regulatory issues and recommend appropriate and effective solutions to Regulatory Affairs management. As a leader, you will be in charge of a team, and that team will be responsible for developing regulatory submissions within an assigned product portfolio.

We ask that applicants for this position have a thorough understanding of the drug development and regulatory process, as well as knowledge of the general principles of nonclinical development chemistry, manufacturing, and clinical development. It is crucial that candidates have at least 4 years experience in regulatory affairs, along with an additional 2 years of experience in biopharmaceuticals. Strong leadership skills are a must, as well as organization, communication, and interpersonal skills. Dedication and self-motivation are also great qualities to have for this position.

Why MedImmune?

In 20 short years, MedImmune has gained a reputation as one of the world’s most robust pipelines in the biopharmaceutical industry. Others in the business view them as a visionary, consistently on the cutting edge of new research and methods. With a spirit of innovation, a heart of inspiration, and the strength of integration, MedImmune continually strives to positively impact as many lives as possible, all through the creativity and passion we put in to medicine.

Here at MedImmune, we value integrity, and strive to incorporate aspects of such as honesty, respect, and communication into our everyday lives and work environment. We are focused on achieving results, and provide a flexible environment that is conducive to optimal productivity. Our commitment to medicine and groundbreaking technology is unlike any other, and as a team we work together to focus on advancing science, initiating positive change, and improving the health of our patients.