Ad Promo Regulatory Advisor

Job Title: Ad Promo Regulatory Advisor

Location: 50% onsite Lawrence Township, NJ 08648

Duration: 6 Months

Duration: Initial 06 months (with possibility to extend up to 2 years)

Willing to consider self-relocation candidate

Top Technical skills

• Oncology experience
• Veeva experience (It should be user level)
• Technical skills with Communication skills
• Min 5+ years of experience
• Promo Material review experience is must

Requirements:

• 5+ years of regulatory ad promo review experience
• 3+ years of Oncology Ad Promo review preferred
• Veeva experience required
• 3+ years with MS Office 365
• Advanced practice degree required (PharmD, JD)

Day to day activities:

• Need to work cross functional
• Candidate will be supporting oncology business; candidates are expected to have a good understanding of US laws implementing medicinal usage.
• They will also be required to review material offline, however certain materials would be reviewed online with senior authorities and medical representatives.

Key Responsibilities

• Regulatory Review & Strategic Guidance: Provide expert regulatory advice and risk assessments on a broad range of advertising and promotional materials, sales training content, and external communications for assigned marketed products.
• Compliance Assurance: Ensure all promotional activities adhere to FDA regulations, approved product labeling, OPDP advisory comments, and relevant guidance documents. Partner with internal teams to proactively identify and mitigate regulatory risks.
• Regulatory Intelligence: Maintain current knowledge of U.S. federal and state laws, regulations, enforcement trends, and policy developments affecting pharmaceutical advertising and promotion. Translate regulatory changes into practical business guidance.
• OPDP Submission Management: Prepare and submit promotional materials to FDA’s Office of Prescription Drug Promotion (OPDP) on Form FDA 2253, ensuring accuracy, completeness, and timeliness.
• Labeling Alignment: Collaborate with cross-functional partners and management teams to ensure updates to U.S. Prescribing Information are consistently reflected across all promotional materials and campaigns.