Job details
Job type full-time
Full job description
Join a great place to work® organization, starting with 4 weeks’ vacation and benefits on day 1! title: regulatory affairs associate full time location: lincolnshire, il/ remote our company nexus pharmaceuticals, a us-based healthcare company, specializes in innovative processes to make difficult-to-manufacture specialty and generic drugs that are easier to use, less labor intensive, and more streamlined in practiceNexus ensures that its high-quality fda-approved drugs fulfill a critical unmet medical need and delivers dependable life-saving treatment options when and where they’re needed mostPosition summary
The regulatory affairs associate will work on chemistry, manufacturing, and controls (cmc) global regulatory submissions for the assigned productsThe incumbent will identify and implement regulatory strategies to support business, ensuring high quality submissions that meet agency expectationsThe incumbent will represent epd ra and will work as a business partner with internal groups at cross-functional meetings to identify opportunities to support market expansion, drive margin improvement, and proactively identify and resolve issues in order to maintain continuity of market supplyThe regulatory affairs associate will work with other functional areas with a focus on cmcRole responsibilities
Maintain and obtain regulatory approvals
Support labeling, advertising, and ectd
Maintain existing approvals with timely reporting
Develop and maintain regulatory expertise in support of product manufacturing
Packaging component review qualifications:
B.sIn scientific, technical, or healthcare field
3 years pharmaceutical industry experience
Background in quality assurance and/or research and development is preferred
Strong understanding of fda regulations in the pharmaceutical industry
Develop regulatory strategies, assess and communicate changes in regulatory requirements,
Respond to agency inquiries
Provide feedback on quality issues that have regulatory impact
Actively work with global cross functional teams to prepare all documentation required for high quality filings in order to meet agreed upon submission timelines.
Maintain compliance with required training.
Required qualifications
3 or more years in regulatory education requirements
Bs or ms in pharmaceutical sciences, chemistry, engineering or related field
Bs or ms in chemistry or related field with a minimum of 20 hours of chemistry coursework.
Must have a minimum* of one year of laboratory experience with a demonstrated proficiency with analytical instrumentation.
This experience should include sample preparation, following written procedures, record keeping, and troubleshooting of analytical instrumentation.
Must have experience or demonstrated ability working with little supervision.
If the candidate has an advanced degree in chemistry, the experience requirement may be waived.
Experience and education
Minimum 3 years work experience in the pharmaceutical industry.
Preferred experience in regulatory affairs, pharmaceutical development, quality or related area(s).
Ability to follow scientific arguments and identify regulatory data needs.
Demonstrates integrity and good business ethics.
Advanced word processing knowledge and experience with microsoft office products (word, excel, visio and powerpoint)
Travel requirements
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 instrumentsAt times low physical effort includes sitting, and operating computers or other small equipmentDisclaimer: the list under role responsibilities are not exhaustive, but are merely the most accurate lists for the current jobManagement reserves the right to revise the job description and to require that other tasks be performed when the circumstances of the job changeEeo statement: nexus is proud to be an equal opportunity workplaceWe are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulationNexus participates in e-verify.
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Posted 5 days ago
