Regulatory Affairs Manager, Advertising & Promotional Material Review

About the Role

Key Responsibilities

• Oversee the review and approval process for advertising, promotional, sales training, and promotional labeling materials, ensuring compliance with all regulatory requirements.
• Assist Regulatory Affairs team with submission to CBER upon Medical, Legal, and Regulatory (MLR) Committee approval.
• Serve as a Subject Matter Expert (SME) on Veeva PromoMats, providing technical guidance and best practices to colleagues regarding material submission and compliance.
• Manage end-to-end workflows within Veeva PromoMats, including metadata validation, reviewer assignment, tier classification, and final sign-off processes.
• Schedule and facilitate live MLR review meetings, summarizing discussions, aligning stakeholders, and ensuring timely reviews, including agenda planning and management of expedited reviews.
• Track and follow up on reviewer feedback, outstanding action items, and next steps to ensure timely resolution.
• Communicate material status updates to relevant stakeholders regularly.
• Support and participate in brand and tactical planning meetings to anticipate upcoming review needs and ensure alignment with business objectives.
• Continuously assess, enhance, and maintain the Ad Promo Review process and SOPs to improve efficiency, effectiveness, and compliance.
• Train employees on the promotional material review process.
• Identify bottlenecks and inefficiencies in the review workflow, streamlining operations, and minimizing material rejections.
• Track KPIs such as review turnaround times and submission quality, implementing improvements as needed.
• Act as a mentor and coach to cross-functional team members, providing guidance on regulatory requirements and best practices.
• Collaborate with cross-functional teams to identify and resolve issues in the review process.

Requirements

• High School Diploma or GED
• Minimum 5 years of experience in regulatory affairs
• Experience in writing and submitting successful regulatory submissions both domestic and international
• Experience with electronic submissions, specifically eCTD and the use of Major Regulatory Authority Platforms/Gateways
• Excellent oral and written communication skills
• Proficiency in MS Office 365 (MS Word, Teams, Excel)
• Experience with Adobe Acrobat and publishing-related plugins and viewers
• Highly motivated and results-oriented leadership style
• Ability to be flexible with changing priorities
• Ability to travel approximately 20%

Nice to Have

• Experience with Veeva PromoMats or similar review management systems
• Knowledge of FDA, CBER, and OPDP regulations
• Experience in the medical device or biologics industry

Qualifications

• High School Diploma or GED
• At least 5 years of regulatory affairs experience

Benefits & Perks

• Annual bonus eligibility
• Health, Dental, Vision insurance
• Matching 401K
• Paid Time Off and 9 Paid Holidays plus 3 Floating Holidays
• Dependent Care Flexible Spending Accounts
• Medical Flexible Spending Accounts
• Tuition Reimbursement
• Paid Parental Leave
• Paid Caregiver Leave
• Basic and Supplemental Life Insurance
• Employee Stock Purchase Plan
• Disability Insurance