Global Regulatory Submissions Lead

Artech Information System LLC; Lawrence Township (NJ); On-site; USD 100,000 - 130,000; Full time

Job summary

A global staffing and IT consulting company is seeking a regulatory affairs professional in Lawrence Township, NJ. The ideal candidate will have over 7 years of experience in the pharmaceutical industry, along with a strong command of English and deep knowledge of US and European regulatory processes. Responsibilities include managing the preparation of regulatory submissions and enhancing team expertise. This role offers a dynamic opportunity for proactive individuals comfortable with electronic submission systems.

Qualifications

• 7+ years of pharmaceutical industry experience or 5+ years with an M.S.
• 2+ years in regulatory affairs/operations is required.
• Long hours may be needed, including nights and weekends.

Responsibilities

• Oversees the preparation of Client global regulatory dossiers.
• Coaches peers to enhance staff expertise.
• Tracks progress of documentation for timely completion.

Skills

Excellent command of English language

Knowledge of US and European regulatory processes

In-depth knowledge of electronic submission requirements

Pharmaceutical experience

Familiarity with dossier publishing tools

Education

B.S. in a relevant field

M.S. in a relevant field

Ph.D. in a relevant field

Tools

Microsoft Office

Documentum

Job description

A global staffing and IT consulting company is seeking a regulatory affairs professional in Lawrence Township, NJ. The ideal candidate will have over 7 years of experience in the pharmaceutical industry, along with a strong command of English and deep knowledge of US and European regulatory processes. Responsibilities include managing the preparation of regulatory submissions and enhancing team expertise. This role offers a dynamic opportunity for proactive individuals comfortable with electronic submission systems.