Regulatory Affairs Manager: FDA Submissions & Strategy

Integrated Resources Inc.; Wayne (PA); On-site; USD 90,000 - 130,000; Full time

Job summary

A leading staffing firm is seeking a Regulatory Affairs Manager for a 6-month contract in Wayne, PA. The role involves managing regulatory activities in line with US requirements, ensuring compliance, and coordinating submissions for products. Ideal candidates will have a BA/B.S in a relevant field and significant biopharmaceutical experience, alongside strong communication and organizational skills.

Qualifications

• 5-10 years of biopharmaceutical experience in regulatory affairs and drug development.
• Knowledge of FDA regulations and drug approval processes.
• Strong communication skills.

Responsibilities

• Function as liaison between FDA and the company for assigned projects.
• Plan and prepare regulatory submissions for assigned products.
• Ensure regulatory compliance for all responsibilities.

Skills

Communication

Collaboration

Organizational skills

Attention to detail

Education

BA/B.S in a scientific, healthcare, or related field

Advanced degree preferred

Job description

A leading staffing firm is seeking a Regulatory Affairs Manager for a 6-month contract in Wayne, PA. The role involves managing regulatory activities in line with US requirements, ensuring compliance, and coordinating submissions for products. Ideal candidates will have a BA/B.S in a relevant field and significant biopharmaceutical experience, alongside strong communication and organizational skills.