Definium Therapeutics - Director, Regulatory Affairs (Advertising and Promotions)
Requirements
• Minimum BS in scientific discipline, advanced degree in science preferred • Minimum 10 years’ experience in the pharmaceutical industry with at least 5 years as a regulatory advertising and promotional reviewer • Experience in CNS 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 supporting product communications and working with FDA (OPDP, APLB) on advertising and promotional matters • Experience in Veeva PromoMats a strong plus • Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee’s geographic location. • Employees in this role may be entitled to additional compensation, including bonus and equity. Benefits information is listed on our Jobs Page. The Company provides competitive benefits to employees including: • 100% paid health benefits including Medical, Dental and Vision for you and your dependents • 401(k) program with company match and vesting after the turn of the first month after your start date • Flexible time off • Generous parental leave and some fun fringe perks! • The starting base pay range for this position: • $215,000—$255,000 USD
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 medical materials in Definium’s PromoMats system • Represent the regulatory perspective in live MLR meetings and concept reviews • Review and approval of social media posts • 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 • 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 • Aid in the development of processes and standards for promotional materials and related activities to facilitate streamlined workflows and encourage an efficient review process • 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
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