Regulatory Associate
Essential Function:
Responsible for reviewing and approving product labels and claims for accuracy and regulatory compliance on cosmetic, drug, and surface disinfectant products. Contribute to the registration of new products as well as the maintenance of regulatory compliance for approved products during the post-marketing phase. Will assist in preparing quality regulatory submissions in compliance with FDA (510K, NDA, ANDA or 505b2), Health Canada (NHP or DIN) or EPA. Must have strong verbal and writing skills and can work independently and pays attention to details.
Scope:
The Regulatory Associate will work in cross-functional teams and support Regulatory Strategies in meetings.
Position responsibilities:
- Review and research regulatory requirements for cosmetics, OTC, Drugs and EPA products.
- Review and approve product labels (based on approved claims)
- General understanding of FDA, EPA and Canadian product labeling regulations
- General understanding of FDA, EPA, Health Canada and ICH regulations
- Assist in writing 510K, NDA, ANDA, and 505b2 submissions to the FDA
- Assist in writing regulatory submissions to Health Canada and EU.
- Review technical documents for accuracy and regulatory compliance.
- Interface with R&D, analytical, purchasing, marketing and sales on regulatory questions and issues.
- Must be able to follow direction and be accountable for work that they are assigned.
- Assist in preparing regulatory documents and presentations for internal meetings
- Perform literature reviews and searches to support regulatory activities
- Maintain Regulatory databases
- All other duties as assigned.
Minimum Requirements:
Equivalent Education Level Requirements:
Minimum BS degree in a relevant scientific discipline for pharmaceutical industry; preferably in chemistry, biology, pharmacy or equivalent.
Experience Required:
- 6 months to 1 year of drug development and pharmaceutical experience in Cosmetics, Drugs, and Medical devices
- Working knowledge of FDA regulations is required. An understanding of foreign (EU, Health Canada and ICH) regulations is a plus.
- Experience in labeling review and approval for Cosmetics, Drugs and Medical devices is preferred.
- Experience in writing and editing technical documents to support regulatory submissions is a plus.
- Experience in 510K, NDA, ANDA and 505b2 submissions to the FDA is a plus.
- Strong verbal and writing skills are required.
- Ability to following SOP and document accordingly required.
- Ability to multi-task and prioritize workload required.
- Must have a team attitude.
Knowledge Required:
Proficient in Microsoft Office applications, data collection (review and analyze information) and general analysis tools.
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