Regulatory Submissions Senior Associate

Publicis Groupe; Philadelphia (Philadelphia County); Hybrid; USD 54,000 - 72,000; Full time

Benefits offered by this job

Medical coverage

Dental

Vision

Disability

401k

Paid time off

Job summary

Digitas Health in the United States is seeking a Senior Associate, Regulatory Operations to lead submission efforts for pharmaceutical clients. You will assemble packages, annotate references, and coordinate with Medical, Legal, and Regulatory review while meeting tight deadlines.

The role requires a bachelor's degree and 2–4 years of experience, proficiency in Adobe Acrobat and Microsoft Office, strong writing and organizational skills, and the ability to manage multiple projects with clear

Qualifications

• Bachelor's degree and 2–4 years of experience in complex submission deliverables under tight deadlines.
• Technical proficiency in Adobe Acrobat and Microsoft Office Suite.
• Clear communication and attention to detail.
• Top-notch organizational skills and concise technical writing ability.

Responsibilities

• Assemble submission packages through screenshots, annotations, and attaching references and documentation.
• Ensure components conform to client and Digitas Health guidelines and requirements.
• Determine time and effort to create submission components; develop delivery timelines with internal teams.
• Balance multiple projects simultaneously and communicate status and timing expectations.
• Skillfully manage client expectations through clear communication.
• Assist in maintaining departmental archive.

Skills

Communication

Attention to detail

Project coordination

Cross-functional teamwork

Education

Bachelor's degree

Tools

Adobe Acrobat

Microsoft Office Suite

Job description

Digitas Health in the United States is seeking a Senior Associate, Regulatory Operations to lead submission efforts for pharmaceutical clients. You will assemble packages, annotate references, and coordinate with Medical, Legal, and Regulatory review while meeting tight deadlines.

The role requires a bachelor's degree and 2–4 years of experience, proficiency in Adobe Acrobat and Microsoft Office, strong writing and organizational skills, and the ability to manage multiple projects with clear