What are the responsibilities and job description for the Regulatory Affairs Associate (CMC, eCTD module 3) position at The Fountain Group?
HYBRID OUT OF NORTH CHICAGO IL
PAY: $37-$42/hr
REQUIRED:
- MS in Reg Affairs with 3 years of pharma exp wirking with CMC module; approximately 5–10 years is ideal
- Hands-on post-approval regulatory submissions for marketed/commercial products
- CMC Regulatory experience or strong familiarity
- EU submissions/variations and broader international regulatory experience strongly preferred
- Experience with lifecycle management, change control and/or regulatory impact assessments
- Ability to manage multiple products and quickly shift priorities
- Experience collaborating with cross-functional and global teams
- Pharmaceutical or biologics industry experience preferred
- Ability to work onsite in North Chicago 3 days per week
Job Description
Looking for an experienced Regulatory Affairs professional with a strong background supporting marketed pharmaceutical/biologic products and post-approval regulatory changes.
The ideal candidate will have hands-on experience with post-approval submissions, variations and/or supplements, along with solid CMC Regulatory knowledge and exposure to global regulatory teams. EU/EMA submission experience is highly preferred.
Salary : $37 - $42