Our client is a producer of Bio-pharmaceuticals. They have developed core competencies in the development of processes and products derived from natural sources both animal-based and plant-based. They have an immediate opening for a Regulatory Affairs Specialist.
- This position will provide regulatory support for development and commercial programs.
- In this role, you will plan, coordinate and oversee regulatory activities.
- These activities include the preparation of document packages for regulatory submissions, and timely preparation of well-organized and technically accurate submissions to the US FDA and other global agencies.
- You will also be responsible for preparing and maintaining internal procedures, such as Standard Operating Procedures (SOP), and ensuring regulation compliance.
- B.S. in Chemistry or Chemical Engineering plus at least 2+ years of experience in cGMP finished dosage form Chemical Manufacturing Control (CMC) is required.
- Personal experience investigating and submitting NDAs, DMFs, and CTAs is highly preferred.
Salary : $57,000 – $80,000