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Regulatory Affairs Manager with Advertising/Promotion

Complete Read and Understand + Instructor-led training for Copy Approval procedures and access to Planner for ad/promo review
Complete CIA training, as required for CAT member
Supervisor-led training for specific guidance and procedures related to Bexsero (e.g., submissions to APLB for 30-day hold) and Shingrix.
Provide general regulatory advice and guidance for ad/promo concepts, including DTC ads.
Interact with APLB reviewers to obtain advice on promotional concepts and strategies.
Review unbranded and branded ad/promo materials in Planner system, per current procedures.
Attend weekly Copy Approval Meetings (1 to 3) to discuss comments on ad/promo items and reach consensus on resolution.
Escalate unresolved issues within Regulatory line management, when necessary.

Preferred background/requirements:

BS/BA in scientific discipline
At least 5 years experience in US-facing RA supporting marketing products, including ad/promo review
Experience with advertising for vaccine products and working with APLB preferred


Travel would be limited to connecting with the manager (in KoP area for the two years) to get setup on client systems and meet colleagues initially. Possible rare meetings face to face likely in KoP.
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