Pharmaceuticals, Quality/Risk Management, Research & Development, Submission & Registration
4 Year Degree
Title: Manager, Regulatory Affairs
Full Time/Part Time: Full Time
Nexus Pharmaceuticals, Inc. is a niche generic pharmaceutical company specializing in injectables. Our priority is to deliver high-quality, innovative and cost-efficient generic pharmaceutical drugs to hospitals and pharmacies.
Position Summary The Manager of Regulatory Affairs will prepare and submit regulatory filing documents. Monitor and track information and requirement changes. Regularly interacts with regulatory agencies, dealing with complex issues, and focuses on new product development. We are looking for a diligent RA professional who works well across functional teams, takes initiative, and enjoys working in a fast-paced team environment.
0-5% Travel required for this role
Physical Demands and Work Environment: Regular (50% - 69%) exertion including standing/walking for extended periods of time, lifting/carrying more than 15 and up to 25 pounds, works with chemicals and wears basic personal protective equipment (PPE) (glasses, gloves, ear protection), and restrictive PPE (tyvek suits, respirators), operates lab instruments. At times low physical effort includes sitting, and operating computers or other small equipment.
DISCLAIMER: The list under Role Responsibilities are not exhaustive, but are merely the most accurate lists for the current job. Management reserves the right to revise the job description and to require that other tasks be performed when the circumstances of the job change.
Compiles and reviews ANDAs, Amendments, Supplements, Annual Reports, etc. for FDA submissions.
• Leads multiple projects, selects methods and provides technical direction to lower-level Associates in the area of regulatory affairs.
• Designs and develops programs, processes and systems used to ensure accuracy and completeness of regulatory submissions, filings and tracking methods. Develops and analyzes alternative solutions.
• 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.
Experience and Education
• Bachelor’s Degree in a scientific related area (Chemistry, Pharmaceutical Sciences)
• Excellent oral and written communication skills
• 7+ years of related professional experience including a minimum of 5 years of regulatory experience.
• Ability to work independently
Strong managerial expertise, comfortable leading a team
• 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!