Pharma Regulatory-Documentation Analyst

3 weeks ago


Oak Brook, United States Lodaat LLC Full time
Job DescriptionJob Description

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 with knowledge of development of biosimilars, biologics, and small molecules.. 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.  This is NOT a wet lab bench-top position.
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 including CDMOs, CMOs, CROs
  • General Admin Responsibilities: meeting scheduling, document organizing

Skills:

  • Knowledge of Biosimilars and small molecule development including upstream, downstream, clinical trial in all phases
  • 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

 

Company DescriptionLODAAT is a USA science-based firm with the objective to provide the world’s best generic pharmaceuticals, nutraceuticals, botanical ingredients. We specialize in producing biosimilars, small molecules and OTC products for all major categories. We are a fast paced, innovate, environment and looking for smart independent people who thrive on challenges.Company DescriptionLODAAT is a USA science-based firm with the objective to provide the world’s best generic pharmaceuticals, nutraceuticals, botanical ingredients. We specialize in producing biosimilars, small molecules and OTC products for all major categories. We are a fast paced, innovate, environment and looking for smart independent people who thrive on challenges.
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