Senior Associate, Regulatory Operation

Company description

CoLab is a fully integrated, cross-discipline team that provides best-in-class services in a fluid and modular way. With our clients at the center, we create brand movement at the speed of people’s lives by connecting real-time data with world-class creative, content, and media in service of growth and Return on investment.

CoLab is a “power of one” solution, encompassing data, media, and production. By drawing from across the vast Publicis Groupe network, we are uniquely positioned to deliver innovation and specialized skills to our clients, as well as enriching opportunities and inclusive benefits to our employees. We pride ourselves on combining the atmosphere of a startup company with the stability and experience of a global leader.

Overview

The Senior Associate, Regulatory Operations is a project-level lead who is responsible for independently preparing promotional materials to be submitted to our pharmaceutical company clients’ Medical, Legal, Regulatory (MLR) review in accordance with both client specific standards and requirements as well as internal guidelines. The Senior Associate is responsible for tracking the progress of each project through the various stages of the MLR review process, advising on submission timelines, and following up directly with internal stakeholders as needed.

Responsibilities

• Assemble submission packages through taking screenshots, annotating pertinent information, and attaching references and other ancillary documentation.

• Ensure components conform to both client and Digitas Health guidelines and requirements.

• Determine the time and effort required to create various components of each submission. Work directly with internal teams to develop submission timelines.

• Comfortably balance multiple projects simultaneously.

• Follow up with internal teams directly to communicate project status and timing expectations.

• Skillfully manage client expectations through clear and concise communication.

• Assist in maintaining departmental archive.

Qualifications

Required

• Minimum of a bachelor's degree and 2-4 years of experience in the preparation of complex submission deliverables under tight deadline constraints

• Technical competency in Adobe Acrobat and the Microsoft Office Suite

• Clear communication and attention to detail

• Top notch organizational skills

• Clear, concise technical writing ability

Preferred

• Experience working on cross-functional teams

• Working knowledge of Adobe InDesign and Photoshop

Desirable

• Experience in Pharmaceutical Industry, Healthcare, or similar environment

• Agency and/or project management experience

Additional information

Our Publicis Groupe motto “Viva La Différence” means we’re better together, and we believe that our differences make us stronger. It means we honor and celebrate all identities, across all facets of intersectionality, and it underpins all that we do as an organization. We are focused on fostering belonging and creating equitable & inclusive experiences for all talent.

Publicis Groupe provides robust and inclusive benefit programs and policies to support the evolving and diverse needs of our talent and enable every person to grow and thrive. Our benefits package includes medical coverage, dental, vision, disability, 401K, as well as parental and family care leave, family forming assistance, tuition reimbursement, and flexible time off.

If you require accommodation or assistance with the application or onboarding process specifically, please contact [email protected].

All your information will be kept confidential according to EEO guidelines.

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Compensation Range: USD $53,960.00 - USD $79,794.00/Annually. This is the pay range the Company believes it will pay for this position at the time of this posting. Consistent with applicable law, compensation will be determined based on the skills, qualifications, and experience of the applicant along with the requirements of the position, and the Company reserves the right to modify this pay range at any time. Temporary roles may be eligible to participate in our freelancer/temporary employee medical plan through a third-party benefits administration system once certain criteria have been met. For regular roles, the Company will offer medical coverage, dental, vision, disability, 401k, and paid time off. The Company anticipates the application deadline for this job posting will be 10/26/2026.