Regulatory Affairs Manager

Avanti Polar Lipids is growing and changing! Come be a part of this exciting time with us.

Avanti has manufactured the highest quality phospholipids, sphingolipids, and sterols for the research and pharmaceutical industry for over 50 years. We have a reputation for purity achieved by a highly trained team working together in a fast-paced, dynamic environment, while maintaining the highest quality standards in the industry.

A recent acquisition by Croda International, “Britain’s Most Admired Chemicals Company”, according to Management Today, is leading to unprecedented cultural change within Avanti. While compensation and benefits continue to remain competitive, we are investing more than ever in employees through tuition reimbursement, incentives, and greater opportunities to begin and grow your career.

Position Summary

As Regulatory Affairs Manager you will oversee regulatory Chemistry, Manufacturing, and Controls (CMC) filings in support of GMP products, and monitor regulatory compliance. Familiarity with a variety of the field's concepts, practices, and procedures is necessary. Relies on extensive judgment to plan and accomplish goals. The successful candidate for this position will execute on a high level of organizational skills, attention to detail, and excellent written and verbal communication proficiency. The Regulatory Affairs Manager may lead and direct the work of others and will report to the Director of Regulatory Affairs and Compliance.
Essential Duties and Responsibilities include the following. Other duties may be assigned.

• Work with functional groups to prepare company submissions (i.e., drug master files)

• Prepare/Review submissions in eCTD format

• Provide client support for regulatory dossiers (i.e., INDs, IMPDs) as needed

• Track submission status, annual report due dates, and assess for change notifications

• Assist in determining the regulatory impact of proposed changes

• Serve as regulatory representative on project teams

• Report regulatory status to the RA Director

Education and/or Experience: Bachelor’s degree in a scientific discipline plus at least 5 years of experience in the pharmaceutical industry, with at least 3 years of regulatory affairs experience or advanced degree or degree/certification in regulatory affairs plus at least 2 years of experience in the pharmaceutical industry. Previous experience in CMC writing (INDs, NDAs or DMFs) is required.

Certificates, Licenses, Registrations: Regulatory Affairs Certification (RAC) or regulatory coursework preferred.

Skills and Abilities:

• Computer Skills - Proficient in basic applications such as Word, Excel, Outlook

• Language Skills - Good command of the English language

• Mathematical Skills - Basic math skills required

• Reasoning Ability - High level of reasoning ability for strategic planning required

• Other - High level of organizational ability and the ability to work with cross-functional teams required

Work Conditions: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The physical demands of the job described in this section are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Job Type: Full-time

Pay: $0.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Disability insurance
• Health insurance
• Life insurance
• Paid time off
• Referral program
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Education:

• Bachelor's (Required)

Work Location:

• One location

Company's website:

• https://avantilipids.com/

Company's Facebook page:

• https://www.facebook.com/AvantiLipids/

Benefit Conditions:

• Only full-time employees eligible

Work Remotely:

• No

COVID-19 Precaution(s):

• Remote interview process
• Personal protective equipment provided or required
• Temperature screenings
• Social distancing guidelines in place
• Virtual meetings
• Sanitizing, disinfecting, or cleaning procedures in place