Associate Director, Global Regulatory Affairs

Associate Director, Global Regulatory Affairs

Cambridge, US;
New Jersey, US | full time | Job

Company Summary

BioNTech is a Nasdaq listed Germany-based global biotechnology commercial stage company with U.S. offices in Cambridge, MA and Gaithersburg, MD, that focuses on developing cancer therapeutics, including individualized immunotherapy, as well as vaccines for infectious diseases, including COVID-19. The company's oncology pipeline contains several classes of drugs, including mRNA-based drugs to encode antigens, neoantigens, cytokines, and antibodies; cell therapies; bispecific antibodies;

antibody conjugates and small‑molecule immunomodulators. BioNTech is partnered with several large pharmaceutical companies, including Roche, Pfizer, and Genmab. Comirnaty (COVID-19 vaccine) is its first commercialized product.

Position Summary

The Associate Director, Regulatory Affairs (Advertising and Promotion) will have accountability for review and approval of US promotional materials and medical communications of assigned brand(s). This colleague will provide input and execute regulatory compliance/strategy related to promotional and advertising campaigns for marketed products and development projects. Provides input into labeling strategies for investigational and marketed products impacting potential US product promotion and is responsible for leading interactions with the FDA Office of Prescription Drug Promotion (OPDP) and Advertising and Promotion Labeling Branch (APLB) pertinent to assigned brand(s).

The individual will be responsible for all submission types made to OPDP/APLB (FDA). The incumbent’s responsibility includes functioning as a leader during review meetings to assure compliance with and evolution of the Promotional Review Committee process enabling business needs to be met efficiently and effectively. This position requires frequent interaction and strong collaboration with Commercial, Medical Affairs, Legal, Global Regulatory Affairs, Labeling and Compliance for the purpose of providing regulatory advice and guidance during promotional plan development all the way through to field implementation assuring conformity with FDA requirements, PhRMA DTC Guidelines and BioNTech policies.

Key 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

Qualifications:

Education

• Minimum BS in scientific discipline

Experience

• Minimum of 8 years experience in the pharmaceutical industry and a minimum of 5 years in regulatory affairs
• Experience in Oncology is a plus
• 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…