Job Title: Regulatory Affairs Specialist
Location: East Brunswick, NJ and Hybrid
Travel Required: <10%
Salary Range: $70-80K+ and health and other benefits
Position Type: Full-time
General Purpose: Provide US regulatory affairs support for all Cronus drug projects.
- Serves as the sponsor administrative professional for completion or coordination of all submissions made to US-FDA/CVM using CVM eSubmitter.
- Author and/or collaborates to develop and maintain SOPs.
- Collaborate with partners, manage and maintain online documentation system for all product files.
- Assist in maintaining all product files in a comprehensive Regulatory file/submission tracking and maintenance system for all product files.
- Complies and supports regulatory file directory structure, naming convention, product file assimilation, and sponsor transfers.
- Assists in CVM submission support in communication of information to our manufacturing site and CMOs for sponsor products.
- Review, complete and submit all annual antimicrobial reporting, DERs, MCSR, and Facility Registrations, etc.
- Perform all drug listings, as applicable, for Cronus and/or distributor labels – original and updates.
- Support Regulatory Team in other activities such as compendium updates, document due diligence acquisition and coordination with document and samples storage facilities.
- Assist in management, disposition, and lifecycle of inventory status of all study samples.
- Review and coordinates development and revisions of labels and marketing materials for submissions to CVM.
- Supports CMC activities in reference label and FOI review, Green Book patent and exclusivity review, trade name selection/filing activities, and FDA databases for product relevant information.
- Collaborate and support Regulatory Team with PV contractor and manufacturing partners for resolution of product complaints and perform periodic audits of pharmacovigilance cases.
- Coordinates with PV contractor to routinely provide necessary updates to Cronus library of products for new Cronus products and customer product information.
- CMC and GLP submission review for accuracy, quality, and completeness per regulatory requirements.
- Coordinate and draft agendas, compile data and supporting information for CVM meeting requests.
- Support Regulatory Team and Management in product and regulatory strategy research.
- Participate in educational opportunities to increase knowledge about regulations, guidances and current regulatory policy.
Qualifications and Education Requirements:
- 3-5 years pharmaceutical industry experience.
- 3-5 years pharmaceutical regulatory affairs experience.
- 2-5 years knowledge and experience with FDA regulations and requirements (GLP and GMP).
- 4 years technical writing and editing.
- 3-5 years regulatory writing and submission experience.
- 2+ years project management experience.
- BA/BS in technical field or scientific discipline (Veterinary Science, Biology, Bio-chemistry).
- Experience with Microsoft Office Suite programs, especially Word, Excel, Project.
- Experience with CVM eSubmitter software.
- Experience with SharePoint or other document and information management software.
- Project management software experience.
- Proficient with FDA QbR and SPL programs.
- Good written and verbal communication skills.
- Good organizational and troubleshooting skills.
- Self-motivated and self-starting.
- Strong interpersonal and organizational skills.
- Excellent written and verbal communication skills.
- Keen attention to detail.
- Highly adaptable.
- English and potentially multilingual, Hinde.