Regulatory Affairs Associate

ProKatchers LLC; South Portland (ME); On-site; USD 65,000 - 85,000; Full time

Job summary

ProKatchers LLC in South Portland, ME is seeking a Regulatory Affairs Associate for a 12-month assignment. The role focuses on researching submission requirements, preparing registration packages, and maintaining regulatory documentation and product listings.

Responsibilities include quality control of documents, updating filings and annual registrations, and supporting postmarket reporting and submissions as needed.

Qualifications

• Conduct research on submission requirements and options.
• Coordinate and assist in the preparation of submission/registration packages.
• Oversee quality control of regulatory documents and submissions.
• Update and maintain global product listings, facility registrations, licenses/approvals, and annual registrations.
• Assist in the preparation of postmarket reports and submissions.

Responsibilities

• Conduct research on submission requirements and options.
• Coordinate and assist in the preparation of submission/registration packages.
• Oversee quality control of regulatory documents and submissions.
• Update and maintain global product listings, facility registrations, licenses/approvals, and annual registrations.
• Assist in the preparation of postmarket reports and submissions.

Skills

Regulatory research

Submission preparation

Quality control

Document management

Education

Bachelor’s degree

Job description

Job Title : Regulatory Affairs Associate

Location : South Portland, ME 04106

Duration : 12 Months

Education : Bachelor’s Degree

Job Description :

• Conduct research on submission requirements and options.
• Coordinate and assist in the preparation of submission/registration packages.
• Oversee quality control of regulatory documents and submissions.
• Update and maintain global product listings, facility registrations, licenses/approvals, and annual registrations.
• Assist in the preparation of postmarket reports and submissions.