Regulatory Affairs Associate

Job Description

We are looking for a dedicated and detail-oriented Regulatory Affairs Associate to join our team. The successful candidate will assist in ensuring our products meet all regulatory standards and help with the preparation and submission of documentation to regulatory agencies. This position is ideal for someone eager to grow their career in regulatory affairs while contributing to compliance in the medical device, pharmaceutical, or biotech industries.

Key Responsibilities:

• Assist in preparing, reviewing, and submitting regulatory documents, including INDs, NDAs, and other regulatory filings.
• Maintain knowledge of current regulatory guidelines and ensure compliance with applicable regulations.
• Coordinate with cross-functional teams to gather necessary data for regulatory submissions.
• Monitor and track the progress of regulatory submissions and communicate updates to stakeholders.
• Support audits and inspections conducted by regulatory authorities.
• Ensure proper documentation and record-keeping of all regulatory materials and communications.

Qualifications:

• Bachelor’s degree in Life Sciences, Chemistry, Pharmacy, or a related field.
• 1-3 years of experience in regulatory affairs or a related role (internships may be considered).
• Familiarity with FDA, EMA, or other global regulatory guidelines and processes.
• Strong organizational and time-management skills to handle multiple tasks.
• Excellent written and verbal communication skills.

Benefits:

• Competitive salary and benefits package.
• Opportunities for professional growth and industry training.
• Comprehensive health, dental, and vision insurance.
• Collaborative and supportive work environment.

How to Apply:
Submit your resume and a brief cover letter explaining your interest in the Regulatory Affairs Associate position and your qualifications.