This late-stage biotechnology company is developing first-in class T Cell based cancer immunotherapies. They are seeking a Director (or Senior Director) Regulatory Advertising & Promotions who will primarily be responsible for managing regulatory aspects of Prelaunch and Post-Marketing regulatory submissions and communications with the FDA for their product portfolio. With their lead candidate in Phase 3, this company offers innovative science, competitive compensation and a patient-focused company culture. This role can be completely remote. Now is an exciting time to join this innovative organization and improve the lives of patients in need!
Responsibilities:
- Foster collaborative, efficient, and effective working relations with FDA in order to further build the cordial working relationship between Company and FDA;
- Develop regulatory, strategic, and compliance plans for maximizing the commercial aspects for the marketing of Company products;
- Manage timelines to achieve stated goals;
- Advise the Corporation on relevant new and existing regulatory risk and compliance requirements and provide regulatory expertise, advice, and support to Sales and Marketing and other product-related teams and the Promotional Review Committee (PRC) and Medical Review Committee (MRC)
- Foster and facilitate teamwork between RA and these allied functions such as legal, marketing, sales, medical affairs;
- Contribute to the development and implementation of Corporate and Department procedures and policies for regulation of marketed promotional materials;
- Provide leadership for and manage regulatory aspects of the PRC review / approval process for product promotional materials, maintain compliance of promotional materials with the governing FDA regulations, and submit promotional materials to APLB in a timely fashion;
- Monitor and interpret promotional labeling regulations and guidelines for the successful and compliant commercial marketing of Company’s products;
- Monitor pro-actively the latest regulations, guidance, and actions from the FDA and competitors that may influence the landscape;
- Provide colleagues in RA and allied functions with cutting edge guidance on requirements and changes;
- Provide recommendations to the RA clinical strategists on Global Project Teams to ensure that regulatory strategy will result in commercially viable U.S. labeling upon which future promotion and advertising will be based Target Product Profile (TPP);
- Maintain awareness of competitor activities by monitoring major U.S. Medical meetings where assigned therapeutic area products are promoted;
- Provide training to Company’s representatives responsible for exhibit booth activities at these meetings;
- Prepare complaint letters to APLB;
- Monitor U.S. regulatory promotional environment by reviewing regulatory promotional guidelines, untitled and warning letters to pharmaceutical companies published by OPDP and APLB, and by attendance of major FDLI, DIA and other industry/FDA meetings;
- Participate in U.S. labeling negotiations and FDA meetings as necessary to support Advertising and Promotions activities;
- Ensure that changes in U.S. Prescribing Information are reflected in current promotions and advertising;
- Mentor Regulatory personnel on advertising and promotion regulations.
Required Qualifications:
- Bachelors in a scientific discipline; advanced degree (MS, PhD, Pharm D) preferred.
- 10 or more years of experience in Regulatory Affairs for pharmaceutical drugs and/or biologics.
- Experience in cell therapy highly desired.
- Excellent knowledge and understanding of U.S. regulations for drug promotion/advertising and U.S. labeling;
- Direct experience working with OPDP and APLB.
- Experience in the review of drug advertising and promotion;
- Proven ability to analyze and interpret efficacy and safety data;
- Strong understanding of business goals of the business, marketing concepts and tools;
- Perform independently with strong negotiation and decision making skills;
- Be able to work in a multi-disciplinary environment;
- Possess strong interpersonal and communication skills;
- Have analytical and problem-solving skills associated with problem reviews and inquiries;
- Be able to provide creative solutions to complex problems.
- Outstanding written and verbal communication skills.
- Must be a collaborative team player who is comfortable wearing many hats in a small biotech environment.
- Must be comfortable with ambiguity within an evolving company.