Regulatory Associate (Boston, MA; Dallas, TX; New York, NY; San Francisco, CA)

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Legal & ComplianceRegulatory

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Quick Summary

Overview

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Key Responsibilities

Prepare, review, and submit regulatory documentation for clinical trial applications, product registrations, and approvals in compliance with relevant regulations (e.g., FDA, EMA).

Requirements Summary

Bachelor’s degree in life sciences, pharmacy, health sciences, or a related field. 2+ years of experience in regulatory affairs, clinical research, or a related area within the pharmaceutical, biotech, or medical device industries.

Technical Tools

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Responsibilities

~1 min read

→Prepare, review, and submit regulatory documentation for clinical trial applications, product registrations, and approvals in compliance with relevant regulations (e.g., FDA, EMA).
→Coordinate and compile data from cross-functional teams to support regulatory submissions.
→Assist in the development of regulatory strategies to ensure timely approval and market access of products.
→Monitor and interpret regulatory guidelines and requirements to ensure compliance throughout the development lifecycle.
→Maintain up-to-date knowledge of regulatory changes and industry standards that impact submissions and processes.
→Communicate with regulatory agencies to facilitate submissions, resolve inquiries, and address any issues that may arise.
→Track the status of submissions and approvals, ensuring that deadlines are met and processes are streamlined.
→Support the creation and maintenance of regulatory documentation archives and tracking systems.
→Provide support in the preparation of regulatory meetings, presentations, and responses to agency requests.
→Collaborate with internal teams, such as clinical, quality, and product development, to ensure alignment with regulatory requirements.

Requirements

~1 min read

Bachelor’s degree in life sciences, pharmacy, health sciences, or a related field.
2+ years of experience in regulatory affairs, clinical research, or a related area within the pharmaceutical, biotech, or medical device industries.
Familiarity with regulatory submission processes and understanding of regulatory requirements (e.g., FDA, EMA).
Strong organizational and project management skills, with an emphasis on detail and accuracy.
Excellent communication skills for interacting with regulatory bodies and cross-functional teams.
Ability to manage multiple tasks and prioritize effectively in a fast-paced environment.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and familiarity with regulatory software or databases is a plus.

Locations:
This position is open to candidates in multiple locations.

This is a contract position

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