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Regulatory Affairs Specialist
2 months ago
We are supporting a small growing biotech company in the life sciences industry, seeking a Senior Regulatory Affairs Associate to join our team at Precision Point Staffing
Key Responsibilities:
- Support the development and implementation of regulatory strategies to ensure compliance with health authorities.
- Collaborate with cross-functional teams to ensure accurate and timely submissions to regulatory agencies.
- Provide regulatory guidance and support for pharmaceutical development, including INDs and CTAs in the US, Europe, Australia, and Asia.
- Manage and maintain regulatory documents, including ICH and CFR guidelines.
- Develop and maintain relationships with regulatory agencies and health authorities.
- Stay up-to-date with regulatory changes and updates, and provide training to the team as needed.
Requirements:
- Bachelor's Degree in a scientific or mathematical area.
- At least 2 years of experience in a regulatory setting at a biotech company.
- Strong foundation in biological or physical sciences, with the ability to apply scientific knowledge to regulatory matters.
- Proficiency with Windows, Adobe, and eCTD software.