Job Description

Associate Director, Regulatory Affairs -Advertising and Promotional Review

Delcath is seeking for a well-rounded FDA regulatory professional with experience or familiarity with promotional and medical material review for approved prescription drugs and/or devices. The position will serve on the company's promotional/medical material review committee for both the United States and Europe for an approved drug/device in the United States and a Class III medical device in Europe. The position will also be required to support other regulatory projects as required, including those relating to clinical trials, early-stage discovery, investigational applications, manufacturing, and quality issues.

Essential duties and responsibilities include the following. Other duties may be assigned.

• Review of promotional and medical material for an approved drug in the United States and a Class III medical device in Europe.
• 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.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• A BS or MS degree in physical or life sciences required.
• Must have at least 5 years drug with Regulatory Advertising and Promotion.
• Must have knowledge of regulations, guidelines, and precedents related to pharmaceutical product development and marketing, with focus in advertising and promotion
• Experience with pharmaceutical products required, drug/device combination product experience a plus.
• Experience working directly/indirectly with the FDA, specifically OPDP/APLB is preferred
• Ability to review promotional materials and interact with FDA OPDP/APLB
• Excellent written/verbal communication skill
• Understanding of clinical trial recruitment materials and labeling regulations
• Experience working across multi-disciplinary levels, functions and regions is required.
• Must be team oriented, with the ability to work well with diverse cross-functional teams.
• Must possess strong analytical and process skills and be computer proficient in EXCEL, MS Project, PowerPoint, Word, etc.
• Must possess strong verbal and written communication skills.
• Must be willing to travel.

Language Skills

Ability to read and interpret documents such as technical journals, safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively with employees and outside organization

Mathematical Skills

Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and create and/or interpret spreadsheets and graphs.

Physical Demands

The physical demands described here are representative of those that must be met by an employee 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 employee will be required to occasionally travel to clinical trial sites.

While performing the duties of this job, the employee is regularly required to sit, stand or walk and talk or hear. The employee is frequently required to use hands to finger, handle, or feel and reach with hands and arms; and is subject to repetitive motions of the wrists, hands, and/or fingers. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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