Provention Bio is seeking an individual to assume primary responsibility for regulatory review of advertising and promotion communications for commercialized products and development programs. This includes advertising and promotion materials, scientific publications, and medical education communications for assigned products. The individual will serve as the regulatory liaison to the FDA Office of Prescription Drug Promotion (OPDP) and will be responsible for making relevant regulatory submissions and responding to FDA communications. The position works closely with the SVP of Regulatory Affairs to ensure appropriate reviews take place and timely submission are made.
- Lead promotional review process to ensure compliance with FDA advertising and promotional regulations and guidelines for designated products, including advertising and promotional materials, scientific publications, and medical education materials.
- Assist with developing and implementing policies and procedures for reviewing advertising and promotional material.
- Thoroughly review and assess proposed advertising and promotional materials as to their completeness, accuracy and compliance with regulatory requirements and Provention Bio policies and procedures.
- Partner with Regulatory, Medical Affairs, Legal, and Marketing departments to ensure timely and efficient review of all materials.
- Serve as regulatory liaison and make applicable submissions to FDA OPDP.
- Provide regulatory advice and support to the company.
- Monitor changes in federal, state and local laws and regulations that impact the U.S. Food and Drug Administration (FDA) requirements for the advertising and promotion.
- Advise company on evolving regulatory requirements related to advertising and promotion.
- Develop and participate in delivering regulatory compliance training to company staff and relevant external parties.
- Provide general project support for the Regulatory Affairs department as requested.
- Bachelor’s Degree required. Advanced degree (MS, PharmD, etc.) preferred.
- 7-10 years related experience, focusing on review and approval of advertising and promotional materials of FDA regulated pharmaceutical products.
- Working knowledge of FDA labeling and advertising regulations/guidances and related aspects of drug product promotion.
- Experience with or ability to be trained on electronic submission for advertising materials.
- Able to read complex regulations and interpret legal and regulatory requirements.
- High degree of attention to details, integrity and discretion.
- Ability to work in a fast-paced entrepreneurial environment.
- Ability to work independently in a virtual home-based position.
- Occasional travel may be required.
Provention Bio is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. All employment is decided based on qualifications, merit, and business need.
To apply, please send resume and cover letter to: firstname.lastname@example.org