Our client is looking to fill the role of Regulatory Affairs Specialist. The primary responsibility is writing regulatory submissions by successfully coordinating with the Regulatory Consultant and Management for priorities and deadlines; while maintaining compliance with cGMP requirements.
Responsibilities:
- Interact with cross functional teams for procurement of documentation required for regulatory submissions.
- Review, manage and write regulatory submissions electronically which include
- New ANDA filings, Complete Response letters, Information requests, Amendments to the ANDA’s (Labeling, Chemistry & Bioequivalence) of different dosage forms (Liquid & Solutions, Others)
- Responsible for filing the Post Approval Supplements like CBE-0, CBE-30 (Changes being effective in 30 days) and Prior Approval Supplements (PAS)
- Review technical documents for accuracy and with supervision, determines acceptability for use in regulatory submissions (i.e. ANDA and NDA)
- Review of the leachable and extractable reports generated for the oral Liquid & Solution drug products.
- Create documents in accordance with eCTD specifications.
- Update and maintain the internal database as needed
- Comply with FDA guidelines/Company Policies of Data Integrity
- Other duties assigned by Management
Required Qualifications:
- Bachelor’s degree in a scientific discipline
- Experience in submission of and approval of ANDAs and supplements; maintaining approved ANDAs in compliance
- Understanding of ICH and FDA guidelines
- Understanding of R&D processes required for ANDA submissions
- Knowledge of regulations/best practices for Rx drug storage/distribution including familiarity with track and trace/ePedigreee requirements.
- Proficient with Adobe PDF, Illustrator/In Design, Microsoft Office and advanced computer skills
- Experience working in an FDA regulated environment
If you meet the required qualifications and are interested in this role, please apply today.
Clinical Resource Network Distinction
CRN, a division of Solomon Page, offers a comprehensive benefits program for hourly employees. We pride ourselves on offering medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits to our employees, including consultants - which sets us apart in the industries we serve.
About CRN
Founded in 2002, Clinical Resource Network (CRN), a division of Solomon Page, provides clinical research and talent solutions for pharmaceutical, biotech, and medical device companies. Focused on forming long-term relationships, services encompass contract staffing, project staffing, consultative services, and full-time placements. For more information, visit and connect with us on Facebook and LinkedIn .
Opportunity Awaits.