Regulatory Operations Associate

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 professionalismwerehired 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 clientside submissions team ensuring expectations are met and submissions are tracked. This role reports to the Associate Director of Regulatory Operations.

PLEASE NOTE:This is a hybrid position requiring onsite collaboration. The role will be based out of our office located in New York City. All candidates must be willing to commute into the office on a regular basis.

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 esubmission 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 detailoriented and organized approach
• Teamoriented 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 multitask and handle a high volume of work in a fastpaced environment

Position requirements

• Bachelors 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 esubmission platforms (Veeva Zinc etc. and PubMed required

Salary range: $58656 $70000

The salary range provided is for the NYChybrid position which requires occasional inoffice 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.