Employment Type : Full-Time
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. 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: 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: Schedule: Education: Work Location: Company's website: Company's Facebook page: Benefit Conditions: Work Remotely: COVID-19 Precaution(s):
Essential Duties and Responsibilities include the following. Other duties may be assigned.