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BioNTech SE · 2 weeks ago

Associate Director, Global Regulatory Affairs - Ad / Promo

Cambridge, MA

Full-time

Onsite

Lead/Staff, Director/Executive

$166K/yr - $203K/yr

8+ years exp

BioNTech SE is a pharmaceutical company focused on improving healthcare through innovative solutions. They are seeking an Associate Director in Regulatory Affairs to oversee the review and approval of US promotional materials and ensure compliance with FDA regulations for their products.

Health Care

Responsibilities

Serve as the internal subject matter expert on FDA Advertising & Promotion matters for assigned product(s) providing regulatory advice and offering solutions to reconcile regulatory comments on draft promotional materials to maintain compliance with FDA regulations

Review and approval of promotional and advertising materials in BioNTech’s content management applications and systems

Ensure timely and accurate FDA 2253 submissions of US promotional materials

Ensure that changes and updates in prescribing information are reflected in current promotional and advertising materials

Liaise with OPDP/APLB (FDA) as needed for assigned product(s) serving as our company's single point of contact with FDA on matters related to advertising and promotional materials. Manage interactions with OPDP/APLB, including response to regulatory inquiries, preparation of complete, accurate, high-quality submissions for advisory comments, and as needed discussion with OPDP/APLB staff

Develop processes and standards for promotional materials and related activities to facilitate stream-lined workflows and encourage proficient practice of process policy

Provide regulatory training as needed on FDA requirements, PhRMA DTC Guidelines and Company policy with respect to best practices in compliance with company policies and guidelines for PRC processes

Demonstrate leadership as the regulatory reviewer on copy approval teams such that recommendations are recognized as well-reasoned, valid and appropriate

Qualification

Regulatory AffairsFDA Advertising & PromotionPromotional Material ReviewFDA SubmissionsOncology ExperienceScientific DisciplineRegulatory TrainingLeadershipCollaboration

Required

Minimum BS in scientific discipline

Minimum of 8 years experience in the pharmaceutical industry and a minimum of 5 years in regulatory affairs

Expert knowledge of advertising promotion regulations and FDA Guidance documents issued with some technical experience in aspects of drug development and labeling

Solid experience with promotional and medical review supporting product communications and working with FDA (OPDP, APLB) on advertising and promotion matters

Oversee OPDP submissions and author all submissions for assigned products