Director of Labeling & Promotional Review

Responsibilities

• Ensure that advertising, and promotional materials meet applicable advertising and promotion regulations. Ensure that medical affairs materials meet applicable regulations.
• Oversee the development, maintenance, and lifecycle management of core labeling documents, including USPI and patient information leaflets.
• Partner with Supply Chain, Commercial, Medical, Legal, Compliance, and Regulatory Operations teams to effectively and efficiently build regulatory compliance into product labeling distribution, marketing and medical strategies and execution. The Regulatory Operations team is based in India.
• As the regulatory lead on the Promotional and the Medical Review Committees, design and optimize Medical & Legal Review (MLR) processes for Promotional and for Medical Affairs pieces, SOPs, and Review Committee operations to strengthen compliance and efficiency.
• Be the point of contact with OPDP, preparing advisory requests, 2253 filings, and engaging in enforcement risk management.
• Provide strategic regulatory input on claims, safety information, and labeling changes, assessing their impact on promotional materials and overall communication strategy.
• Train internal teams on FDA enforcement trends, guidance updates, and best practices.

Qualifications - Skills & Requirements

• Deep understanding of advertising, medical affairs, and labeling regulations, FDA OPDP expectations, and enforcement trends.
• Ability to balance compliance with marketing innovation, translating complex regulations into actionable guidance.
• Experience in streamlining review cycles while reducing risk of enforcement action.
• Strong collaboration skills across cross-functional and external (e.g., FDA) stakeholders.
• Ability to effectively assess and communicate risk to inform strategic decisions.

Education & Experience

• 10+ years of regulatory affairs experience in the biotech or pharmaceutical industry, with at least 5 years in labeling and promotional review, preferably with experience in product launch and/or accelerated approval product.
• Deep knowledge of FDA regulations on labeling, promotion and new drug applications (21 CFR Parts 201, 202, 314).
• Proven track record of leading cross-functional promotional review committees (PRC/MRC).
• Proven track record of translating complex regulatory requirements into actionable language and guidance.
• Strategic mindset with the ability to communicate risk effectively and balance compliance with business objectives.

Travel

• Limited travel required.

Work Environment

• This is preferably a hybrid office-based position, located in our office in Princeton, NJ. Alternatively, this position may be remote, but from time to time or when required, the employee will be required to report to our office.
• The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job, the individual is:
  • Frequently required to sit and/or stand, walk, talk, and hear.
  • Ability to sit at a computer for an extended period of time.
  • Vision ability requirements include clarity of visions at 20 inches or less due to computer work.
  • Moderate noise (i.e., background noise due to computers, phone, printers, and light hallway traffic).
  • Constantly required to use hands and fingers to operate office machines and equipment.
  • Frequently required to reach with hands and arms. Occasionally required to stoop, kneel, and crouch.