Regulatory Submissions Associate I – Onsite

Collabera; Florham Park (NJ); On-site; USD 46,838 - 52,348; Full time

Benefits offered by this job

Medical insurance

Dental insurance

401(k) retirement plan

Paid vacation time

Job summary

A leading pharmaceutical firm in New Jersey is seeking a Regulatory Affairs Associate I to manage low- to medium-impact regulatory submission projects. You will be responsible for coordinating submission activities, ensuring compliance with regulatory standards, and working collaboratively with cross-functional teams. The ideal candidate has a Bachelor’s degree and at least 2 years of experience in a similar role. This contract position offers competitive pay and benefits.

Qualifications

• Minimum of 2 years of pharmaceutical or industry‑related experience.
• Experience performing quality reviews of regulatory documents.

Responsibilities

• Manage low- to medium‑impact regulatory submission projects.
• Prepare content planners for publishing and coordinate submission publishing.
• Perform detailed quality reviews of published submissions.

Skills

Experience supporting regulatory submission activities

Ability to manage multiple concurrent submission projects

Familiarity with regulatory submission standards

Experience coordinating cross‑functional teams

Education

Bachelor’s Degree

Tools

Documentum

Adobe Acrobat

eCTDXPress

Job description

A leading pharmaceutical firm in New Jersey is seeking a Regulatory Affairs Associate I to manage low- to medium-impact regulatory submission projects. You will be responsible for coordinating submission activities, ensuring compliance with regulatory standards, and working collaboratively with cross-functional teams. The ideal candidate has a Bachelor’s degree and at least 2 years of experience in a similar role. This contract position offers competitive pay and benefits.