BGB Group 

Regulatory Operations Associate

Our Agency 

BGB is a healthcare communications agency that offers a wide range of services, including traditional pharmaceutical advertising, promotional medical education, payer marketing, and consulting services. Known for excellence and professionalism, we’re hired as strategic and creative partners by our biopharmaceutical clients to drive category/brand awareness and growth. 

Position Overview 

The Reg Ops Associate is responsible for consistent client submission success. Working closely with the Account, Project Management, Editorial, Medical, and Creative teams, they will ensure all client submission guidelines are understood and met for our pharmaceutical clients’ medical/legal/regulatory (MLR) submissions, and partner with Account to assemble all submission components, including tagging, linking, and uploading of submission files and support materials (including references). The Reg Ops Associate will work with their supervisor to maintain client reference libraries, perform reference checks prior to submission and develop, as needed, claims lists for their designated brands, as well as keep a submissions calendar laying out key upcoming dates. As they gain experience, Reg Ops Associates grow to develop and maintain relationships with the client-side submissions team, ensuring expectations are met and submissions are tracked. This role reports to the Associate Director of Regulatory Operations.

Role Requirements:

The Regulatory Operations Associate must be able to fulfill the responsibilities under the direct supervision of his/her manager or designated senior team member

  • Maintain knowledge and expertise on how to successfully submit a project for medical/legal/regulatory (MLR) review based on different clients’ procedures and guidelines as well as agency standard operating procedures
  • Collaborate with the account, project management, editorial, medical, and copy teams to prepare and submit completed medical education and promotional advertising projects for MLR submissions
  • Under guidance of supervisor, establish and cultivate relationships with MLR counterparts to discuss submissions, MLR reviews, and any relevant updates
  • Learn and enforce industry standards for all MLR submissions per either FDA/OPDP regulations or global markets standards, as well as agency and Pharmaceutical Client specifications
  • Maintain a submissions calendar for their books of business, tracking all upcoming submissions and working closely with the Account and PM teams to strategize how best to prepare submissions
  • Prepare and complete submissions
    • Perform QC of submission components prepared by team before moving forward
    • Tag and link references within e-submission portals for various brands
    • Insert any functional annotations or comments directed to MLR reviewers
  • Schedule and manage multiple brands’ weekly or daily submission status meetings
  • With guidance, create, uphold, and maintain submission checklists per brand

Preferred Qualifications

Desired Skills

  • Extremely detail-oriented and organized approach
  • Team-oriented outlook and interpersonal skills
  • Enthusiasm for the sciences
  • Predisposition to learning and knowing the rules (from FDA regulations to the clients’ submission guidelines)
  • Technological savvy
  • Can effectively manage time, multi-task, and handle a high volume of work in a fast-paced environment

Position requirements

  • Bachelor’s degree (English, Communications, or any scientific field preferred)
  • Experience in science, medicine, or at a pharmaceutical advertising agency preferred
  • Proficiency in Adobe Acrobat and PowerPoint as well as other Microsoft Office applications (Word, Outlook, Excel, OneNote)
  • Familiarity with e-submission platforms (Veeva, Zinc, etc.) and PubMed required

Salary range: $58,656 - $70,000 

The salary range provided is for the NYC-hybrid position, which requires occasional in-office presence, and represents what a potential hire may expect to earn in this role at BGB. For candidates in other locations, salary will be adjusted to reflect local market rates. Actual salary decisions will be influenced by several factors that we use to determine overall fit, including experience (both direct and indirect), education, training, demonstrated qualifications, and organizational need. Salary is only one component of the total rewards package offered at BGB Group. 

BGB Group is an equal opportunity employer. All applicants will be considered without regard to race, color, religion, sex, age, national origin, citizenship status, sexual orientation, disability, veteran status or any category or class of person protected by law. 

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