Global Regulatory Submissions Lead

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

Benefits offered by this job

Professional development opportunities

Competitive benefits package

Job summary

A leading pharmaceutical organization is seeking an experienced Project Manager for Regulatory & Medical Affairs in Lawrence Township, NJ. This role involves overseeing the preparation and submission of regulatory dossiers, ensuring compliance with regulations, and managing a team. Ideal candidates should have substantial pharmaceutical industry experience with expertise in regulatory processes and knowledge of electronic submission requirements. Competitive salary and benefits offered, including opportunities for professional development.

Qualifications

• 7+ years of experience in the pharmaceutical industry required.
• Minimum 2 years in regulatory affairs/operations needed.
• Experience with drug development principles is desired.

Responsibilities

• Oversees preparation and submission of regulatory dossiers.
• Ensures submissions meet regulatory requirements.
• Manages and mentors resources involved in dossier production.

Skills

Excellent command of English language

Knowledge of US and/or European regulatory processes

Ability to work in electronic document databases

Education

B.S. in a relevant field

M.S. in a relevant field

Ph.D. in a relevant field

Tools

Microsoft Office

Documentum

eCTD viewers

Job description

A leading pharmaceutical organization is seeking an experienced Project Manager for Regulatory & Medical Affairs in Lawrence Township, NJ. This role involves overseeing the preparation and submission of regulatory dossiers, ensuring compliance with regulations, and managing a team. Ideal candidates should have substantial pharmaceutical industry experience with expertise in regulatory processes and knowledge of electronic submission requirements. Competitive salary and benefits offered, including opportunities for professional development.