Job Description
Note: The job is a remote job and is open to candidates in USA. KPG99 INC is seeking a highly experienced Executive Director or Director of Regulatory Affairs – Advertising & Promotion to support promotional review activities in the addiction treatment space. This role involves serving as a key regulatory reviewer within the MLR review process and ensuring compliance with FDA promotional regulations and current labeling.
- Responsibilities
- Serve as the primary Regulatory Ad/Promo reviewer within the MLR review process
- Review and approve promotional materials within Veeva PromoMats
- Ensure consistency with FDA-approved labeling and applicable FDA guidance
- Provide expert interpretation of FDA regulations and OPDP expectations
- Support Form 2253 submissions to OPDP (preferred)
- Review corporate communications and external-facing materials
- Partner closely with Legal and Medical teams to ensure compliant messaging
- Act as an SME on evolving FDA promotional guidance and labeling updates
- Escalate regulatory risks appropriately and professionally
- Skills
- 10+ years of hands-on Regulatory Ad/Promo experience within the pharmaceutical industry
- Deep knowledge of OPDP requirements and FDA advertising regulations
- Extensive experience in MLR/PRC review environments
- Advanced proficiency with Veeva PromoMats
- Strong working knowledge of CDER promotional regulations
- Executive presence with the ability to collaborate cross-functionally
- Strong written and verbal communication skills
- Experience submitting Form 2253 materials
- Experience in CNS, behavioral health, or addiction therapeutic areas
- Company Overview
- Our business consulting services are led by significant domain depth built on a robust technology-driven services platform. It was founded in 2013, and is headquartered in Hampton, New Jersey, USA, with a workforce of 51-200 employees. Its website is https://www.kpg99.com/.
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