Pharma Regulatory-Documentation Analyst

Exciting opportunity as a Regulatory Analyst in the Pharmaceutical Division.
Candidates should have a science-pharma background with good technical writing and online research abilities. An understanding of analytical methodology & procedures, stability studies is a plus. PHD, Post-Doc and MD candidates are preferred, but other education levels are also accepted. This is an independent role, in a fast paced team environment with writing deadlines. Candidates should be a fast learner and will have the opportunity to learn the ins and outs of the pharmaceutical industry, generic drug markets, and regulatory affairs.
Responsibilities:

• Read, understand and follow US FDA and international guidelines for pharma submissions
• Technical Report writing for pharmaceutical dossiers
• Research online regulatory guidelines to align documentation
• Organization of pharmaceutical dossier modules
• Communicating with customers and vendors
• General Admin Responsibilities: meeting scheduling, document organizing

Skills:

• Understanding of CTD, E-CTD documentation and all modules for pharma regulatory submission
• Understand international (EU, GCC, LATAM) regulatory requirements
• Research ability: searching databases & comprehending research articles
• Organizational skills is a MUST
• Strong oral and written communication skills
• Technology understanding: outlook, PDF, microsoft suite

Role offers flexible schedule
Please note, this is NOT a wet lab position

Benefits:

• Flexible schedule

Schedule:

• Monday to Friday

Ability to commute/relocate:

• Oak Brook, IL: Reliably commute or planning to relocate before starting work (Required

This position is for someone who is enthusiastic and hard-working. Dealing with regulatory documents is tedious and requires proficiency using PDF software.

1. Understands basic chemistry and/or Biology
2. Some experience working in the health care or pharmaceutical industry
3. Enthusiastic about the work and is task oriented
4. Familiar with PDF and/ or AI editing tools
5. Able to tackle tasks under-pressure and prioritize multiple assignments
6. Demonstrates professionalism for team and customer meetings and timeliness