Job Order: 4405
Staff Representative: Tim Jadwin
Position: Regulatory Affairs Associate
Location: Illinois
Company Summary:
A leading supplier of specialty and generic liquid pharmaceutical products.
Description:
The qualified individual will manage the Regulatory Affairs activities for designated projects, and be responsible for the preparation of regulatory submissions under an appropriate supervision.
Typical Duties:
- Preparing, compiling, reviewing, and processing regulatory submissions, including ANDA, supplements, annual reports, field alert reports, study protocols and study reports.
- Coordinate and consult with other departments on the content, review, and assembly of regulatory documentation. Ensure consistency, completeness, and adherence to standards for all regulatory submissions
- Participate in the project/regulatory submission team and provide clear and consistent regulatory recommendations under an appropriate supervision.
- Help develop labels/labeling
- Contribute to developing regulatory strategies (CMC, clinical and non-clinical).
- Interface with the FDA under a direct supervision and handle all correspondence with governmental agencies.
- Manage drug recalls
- Create regulatory project plans and timelines for multiple projects or developmental programs
- Keep supervisor informed of all key regulatory issues
- Ensures maintenance of regulatory document archive
- A BA/BS in a scientific, health care, or related field or equivalent experience.
- At least 2 years of biopharmaceutical experience with emphasis in regulatory affairs and drug development
- Knowledge of FDA regulations and guidelines on drug development and the approval process for NDA/ANDA and post-marketing supplements
- Strong written/verbal communication skills
