Regulatory Affairs Associate

Regulatory Associate

We are seeking a detail-oriented Regulatory Associate to join our Regulatory Affairs team. In this role, you will play a vital part in supporting the development and submission of regulatory documents, ensuring compliance with all regulatory standards, and facilitating the approval process for clinical trials and product launches. This position offers the opportunity to work closely with cross-functional teams and contribute to regulatory strategies across a variety of projects.

Responsibilities:

• 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:

• 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.