Regulatory Affairs Leader – Advertising & Promotion

Delcath Systems, Inc.; United States; On-site; USD 140,000 - 190,000; Full time

Job summary

Delcath Systems, Inc. is seeking an Associate Director of Regulatory Affairs to lead advertising and promotional review for US and European programs involving an approved drug/device.

You will oversee cross-functional teams, provide regulatory guidance to Commercial and Medical Affairs, interact with FDA OPDP, and help shape compliant product messaging across labeling, trial materials, and communications.

Qualifications

• BS or MS in physical or life sciences.
• 5+ years in regulatory advertising and promotion.
• Knowledge of pharma regulations and promotion guidelines.
• Experience with drug/device combinations a plus.
• Experience with FDA interactions and OPDP/APLB.
• Ability to review promotional materials and advise cross-functional teams.
• Understanding of labeling regulations and clinical trial materials.
• Experience working across regions and multi-disciplinary teams.
• Strong analytical, written and verbal communication skills.
• Willingness to travel.

Responsibilities

• Management of US and Global regulatory activities associated with advertising and promotion for company marketed products.
• Provide review of US and Global product and disease state materials/communications to support corporate goals and comply with applicable laws, regulations, and guidance.
• Contribute to and advise on the development of product messages and materials across multiple functional areas, including clinical trial materials.
• Provide timely regulatory advice and guidance to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs
• Collaborate cross functionally with key stakeholders in areas such as Marketing, Medical Affairs, and Legal.
• Help lead and assist in interactions with the FDA Office of Prescription drug Promotion (OPDP), responsible for helping to maintain good working relationship and effective communication with FDA OPDP reviewers with respect to advertising and promotion matters.
• Responsible for compliance with promotional material submissions to FDA on Form 2253
• Monitors the evolving regulatory landscape and requirements, and maintain vigilance regarding FDA promotional enforcement activities to, in partnership with management, provide stakeholders with updates and impact of enforcement activities.
• Ability to identify process improvement for promotional review activities that would enable the establishment of portfolio wide standardization of policies.
• Provide input during labeling development and negotiation to reflect commercialization objectives and messages that impact promotion and advertising.
• Support regulatory affairs department in other tasks as needed.

Skills

Regulatory advertising & promotion

FDA interactions

Review of promotional materials

Cross-functional collaboration

Analytical skills

Written and verbal communication

Willingness to travel

Education

BS or MS in physical or life sciences

Tools

Excel

MS Project

PowerPoint

Word

Job description

Delcath Systems, Inc. is seeking an Associate Director of Regulatory Affairs to lead advertising and promotional review for US and European programs involving an approved drug/device.

You will oversee cross-functional teams, provide regulatory guidance to Commercial and Medical Affairs, interact with FDA OPDP, and help shape compliant product messaging across labeling, trial materials, and communications.