USA-Regulatory Affairs Specialist II - Bridgewater, United States - eTeam

Description

Regulatory Affairs Specialist II (Clinical)

Bridgewater, NJ-100% Remote

7 Months contract

Pay Rate:
$45-55/hr on w2

Candidates can be located in any US time zone, they must be able to work EST hours from 9AM-5PM EST Possibility of Extension Role will work independently and as a team Minimum of 3 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry, with a focus on IND maintenance activities for oncology products.

Excellent communication skills in English, both written and verbal, with the ability to collaborate with internal employees.

Top must-have skills:

• - 6 Years; US-specific knowledge required within IND = investigational new drugs: this could be any pharma area not limited to, but examples are: therapeutic areas within immune, neurology, cardiology
• Experience, and familiarity with regulatory science
• Strong understanding of how IND/ investigational new drugs process Nice to

Have Skills:

• Experience as a US contact for FDA would be a strong plus

This role will be in support of oncology assets that have been terminated by the company


Responsibilities include:

• Manage and execute regulatory activities related to the maintenance of investigational new drug (IND) applications for oncology products in compliance with FDA regulations and guidelines.
• Coordinate the preparation, review, and submission of regulatory documents, including annual reports, safety updates, amendments, and notifications to support IND maintenance activities.
• Support the preparation and execution of IND withdrawal activities as needed, including the development of withdrawal strategies, communication plans, and regulatory submissions.

Years of Experience: - 6 Years; US-specific knowledge required, but physical location can be global.


Minimum Education:
Bachelors Degree