Ad Promo Regulatory Advisor

Ad Promo Regulatory Advisor at Net2Source (N2S) Ad Promo Regulatory Advisor at Net2Source (N2S) in Trenton, New Jersey Posted in 3 days ago.

Type:

full-time

Job Description:

Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap

• Right Talent
• Right Time
• Right Place
• Right Price and acting as a Career Coach to our consultants.

Company:

One of Our Clients Job Description:

Job Title:

Ad Promo Regulatory Advisor Location:

50% onsite at Princeton Pike, NJ 08648

Duration:

06+ Months (Extendable)

Hours:

Mon-Fri 8am-5pm

Pay Rate:

$90.00

• 95.

82/hr on W2 To meet the role requirements, candidates must have: Direct experience conducting regulatory review of prescription drug promotional materials (not medical devices). Experience providing clear, actionable OPDP-aligned regulatory advice. A solid understanding of FDA regulations and enforcement related specifically to prescription drug promotion. Position Overview The Ad Promo Regulatory Advisor plays a critical role in ensuring that all U.S. advertising, promotional materials, and external communications for marketed pharmaceutical products comply with FDA regulations and industry standards. This position partners closely with cross functional teams to provide strategic regulatory guidance, assess risk, and support compliant product promotion in a fast paced, matrixed environment. 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. Required Qualifications
• Educational Background Bachelor's degree in a Life Science discipline required; advanced degree strongly preferred (MS, PhD, PharmD, or JD).
• Regulatory Experience Minimum of 5-6 years of regulatory promotional review experience within the pharmaceutical or biotechnology industry.
• Expertise in Promotional Regulations Demonstrated experience providing strategic regulatory direction to interdisciplinary teams on promotional strategies and materials. Strong interest and knowledge of FDA promotional regulations and guidance.
• Industry or FDA Experience Broad hands on pharmaceutical experience or prior FDA regulatory experience (e.g., OPDP) is highly desirable.
• Project & Stakeholder Management Proven ability to manage multiple complex projects, identify and resolve issues, deliver on commitments, and work effectively across multidisciplinary teams.
• Leadership & Organizational Skills Strong leadership presence with the ability to influence, drive alignment, and deliver optimal business results in a dynamic, matrixed environment.

Awards and Accolades:

America's Most Honored Businesses (Top 10%) Awarded by USPAAC for the Fastest Growing Business in the US 12th Fastest Growing Staffing Company in USA by Staffing industry Analysts in the US (2020, 2019, 2020) Fastest 50 by NJ Biz (2020, 2019, 2020)

INC 5000

Fastest growing for 8 consecutive years in a row (only 1.26% companies make it to this list) Top 100 by Dallas Business Journal (2020 and 2019) Proven Supplier of the Year by Workforce Logiq (2020 and 2019) 2019 Spirit of Alliance Award by Agile1 2018 Best of the Best Platinum Award by Agile1 2018 TechServe Alliance Excellence Awards Winner 2017 Best of the Best Gold Award by Agile1(Act1 Group)