Director, Regulatory Affairs Advertising & Promotion

Proclinical, in support of our client, are seeking an individual to fill the role of Director of Regulatory Affairs Advertising & Promotion, based in Cambridge, MA (Onsite - offering relocation support). The successful candidate will be responsible for providing strategic guidance on the development and implementation of a creative and compliant advertising and promotion program.

Responsibilities

• Serve as the primary regulatory advertising and promotion reviewer on cross-functional Promotional Review Boards for the successful launch of commercial programs, and on Medical Review Boards for the compliant scientific exchange of information of investigational programs.
• Act as primary contact with FDA's Office of Prescription Drug Promotion (OPDP), including responding to agency inquiries and managing company requests for advisory review.
• Develop solutions to complex US promotional issues.
• Identify and provide guidance on development and improvement of policies, processes, and standards for promotional materials and related activities.
• Work closely with Regulatory counterparts to ensure that global development strategies result in commercially viable labeling, in support of desired promotional claims.
• Participate in training personnel on advertising and promotional materials, as required.
• Provide oversight to relevant external vendors and consultants.
• Monitor and organize US regulatory promotional environment.

Skills And Qualifications

• BA/BS in a related field (advanced degree preferred) and 10+ years of relevant industry experience, with 7+ years of regulatory-focused experience.
• Experience with launching new products and/or new indications required; oncology experience preferred.
• Direct experience interacting with OPDP required.
• Experience working on an accelerated approval product a plus.
• Solid understanding of business goals and common marketing concepts/tools.
• Experience in managing multiple global programs required.
• Strong written, verbal, and interpersonal communication skills.
• Proficiency in Microsoft Office suite.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Kyle Weber at (+1) 646-367-2618 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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