Senior Manager Regulatory Affairs Advertising & Promotion

About the role

The Senior Manager Regulatory Affairs Advertising & Promotion is the overall PRC Coordinator for the Promotional Review Committee (PRC) materials process.

Responsibilities

• Act as PRC Coordinator for PRC team, facilitate and document required changes and comments during PRC meetings, maintain Medical Affairs material library in Veeva Vault to ensure materials stay in compliance with the PRC SOP (e.g., continued use), and coordinate quarterly planning meetings
• Manage the Approved for Distribution process including facilitation of branded promotional materials to FDA on Form 2253 which includes coordinating and scheduling 2253s with Regulatory Publishing, review all content prior to 2253 submission, verify materials were successfully received through the gateway and take appropriate action to mark materials as Approved for Distribution, ensuring the appropriate expiration date is captured and work with internal Reg Ops team to ensure 2253 submissions are appropriate archived in Veeva RIMS
• Maintain submission guidelines to meet 2253 technical requirements
• Ensure materials and system are constantly monitored in the event of an internal or external audit
• Manage label change communications, pull material reports from Veeva to identify changes required, and update Veeva to reflect label change modifications needed
• Maintain PRC submission guidelines, PRC Training materials, Veeva Vault user guides, etc.
• Fulfill promotional material audit requests from FDA and other internal parties
• Provide strategic 2253 submission support to cross functional partners
• Manage product label updates to ensure materials are revised, resubmitted for PRC Review, and submitted to FDA on form 2253
• Provide regulatory guidance on Veeva Vault and PRC process enhancements to ensure compliance and process efficiencies
• Review selected materials (ISI updates, other minor changes, and continued use routings) in Veeva Vault and actively participate in PRC meetings
• Ensure that projects are completed on schedule following established procedures and timelines as it relates to the process and submissions to the FDA

Qualifications

• Bachelor's degree in a related discipline and 5 or more years of related experience, or the equivalent combination of education and experience

Skills

• Strong Regulatory and Operations knowledge
• Demonstrated success in the preparation and submission of regulatory documents
• Strong understanding of the role of Ad Promo regulatory leadership coordinator role
• Experienced user of the with Veeva Vault system of review
• Collaborative in nature, able to work within a cross-functional team to ensure compliance while meeting the needs of the commercial and medical organizations
• Excellent verbal and written communication skills are required
• Ability to work in a fast-paced, dynamic environment with little supervision
• Ability to adapt well under pressure
• Ability to prioritize and manage multiple priorities and responsibilities simultaneously and follow-through on issues in a timely manner
• Strong collaboration skills
• Effective verbal and written communication skills
• Proficient in the use of business productivity software (Excel, Word, PowerPoint, etc.)

Pay

Travel may be required up to 15% of time worked