Job Description

Senior Director/ Executive Director, Regulatory Affairs

Regulatory & Quality – Regulatory

Exempt Full-time

On-site

Job Responsibilities

As a Senior Director/ Executive Director in Regulatory Affairs, you will be responsible for overseeing regulatory strategy and compliance for the company. Your key responsibilities will include:

1. Developing and implementing regulatory strategies for product submissions.
2. Ensuring compliance with FDA and other regulatory agencies.
3. Leading cross-functional teams to ensure timely submission of regulatory documents.
4. Maintaining up-to-date knowledge of regulatory changes and industry trends.
5. Providing guidance and training to staff on regulatory requirements.

Qualifications

The ideal candidate will possess the following qualifications:

1. Advanced degree in a relevant field (PhD, MD, or equivalent).
2. 10+ years of experience in regulatory affairs, preferably in the biotech or pharmaceutical industry.
3. Strong understanding of FDA regulations and submission processes.
4. Excellent communication and leadership skills.
5. Proven track record of successful regulatory submissions.

Application Process

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