Quality/Risk Management, Regulatory Compliance, Research & Development, Submission & Registration
4 Year Degree
Nexus Pharmaceuticals, Inc. is a niche generic pharmaceutical company located 30 miles north of Chicago in Vernon Hills, Illinois. Since 2006, we’ve delivered high-quality, innovative and cost-efficient generic pharmaceutical drugs to hospitals and pharmacies.
The Regulatory Affairs Associate will help with submitting regulatory filing documents and monitor and track information and requirement changes. The Associate will regularly interact with regulatory agencies, deal with complex issues, and focus on new product development. Nexus is looking for a diligent RA professional who works well across functional teams, takes initiative, and enjoys working in a fast-paced team environment.
• Compiles and reviews ANDAs, NDAs, Amendments, Supplements, Annual Reports, etc. for FDA submissions.
• Designs and develops programs, processes and systems used to ensure accuracy and completeness of regulatory submissions, filings and tracking methods.
• Ensures policies and practices are reviewed and revised as needed.
• Works independently. Interfaces with all levels of management negotiating and influencing to build consensus.
• Presents programs internally and externally.
• Work is focused on operational plans in support of strategic goals.
• Bachelor’s Degree in Chemistry
• Excellent oral and written communication skills
• 2 years of Regulatory experience
• 2 years of Labeling and Submission Experience
• Experience with filing NDA (New Drug Applications) and ANDA (Abbreviated New Drug Applications
• Ability to work independently
• Generic Injectable experience
Internal Number: 1
About Nexus Pharmaceuticals, Inc.
Nexus Pharmaceuticals, Inc. is a niche generic pharmaceutical company located 30 miles north of Chicago in Vernon Hills, Illinois. Since 2006, we’ve delivered high-quality, innovative and cost-efficient generic pharmaceutical drugs to hospitals and pharmacies. Our industry experience runs deep, backed by years of expertise in the pharmaceutical industry, ranging from analytical and formulation development to navigating the FDA approval process. Currently, we have a robust pipeline of injectable products in a variety of therapeutic classes. Our company specializes in developing sterile injectable products for the US market. At Nexus we place a high value on what each employee can bring to the company. We reward hard work and dedication yet also emphasize work life balance. Come join our growing team!