Regulatory Affairs Specialist
2 months ago
A dynamic company, 5TH HQ LLC, is currently seeking a detail-oriented and motivated professional to join their team as a Regulatory Affairs Specialist. This role plays a crucial part in ensuring compliance with regulatory requirements for their products, making it a key position within the organization.
Key Responsibilities:- Prepare and review regulatory documents to comply with FDA and other regulatory authorities.
- Stay updated on regulations, guidelines, and standards in the pharmaceutical industry.
- Assist in preparing regulatory submissions like NDAs, INDs, and amendments.
- Collaborate with cross-functional teams to gather information for submissions.
- Communicate effectively with regulatory authorities.
- Monitor submission progress and address inquiries from regulatory bodies.
- Develop and implement regulatory strategies for product approvals.
- Maintain organized regulatory files and records.
- Bachelor's degree in biology, chemistry, or pharmaceutical sciences.
- Prior experience in regulatory affairs within the pharmaceutical industry.
- Excellent understanding of FDA regulations.
- Strong organizational and time management skills.
- Detail-oriented with the ability to manage multiple projects.
- Effective written and verbal communication skills.
- Proficiency in Microsoft Office Suite.
- Ability to work independently and collaboratively.
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Regulatory Affairs Specialist
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