We are seeking a highly motivated, results-focused Senior Director, Regulatory Affairs - Labeling and Promotion with mastery in the disciplines of product labelling strategy and regulatory oversight of advertising, promotion and medical education materials. Aside from their responsibilities for labeling documents for all products in the pipeline, their initial primary focus will be on supporting our key cardiovascular product, sotagliflozin, in the pre-approval, launch and post-launch phases. They will play a key role in guiding the company in effectively communicating the value of sotagliflozin to prescribers, payors, and patients in a competitive market while ensuring consistency with approved labeling and compliance with regulatory standards. This role demands a poised and articulate individual who is able to lead across functions and build effective working relationships across the organization.
The Senior Director, Regulatory Affairs - Labeling and Promotion will be responsible for leading the development and maintenance of labeling and related documents (Target Product Profile, Company Core Data Sheet, US Prescribing Information, Summary of Product Characteristics) for all Lexicon products throughout the product lifecycle, including during development, in preparation for submission in marketing applications and supplements, and following launch. They will participate in negotiations with FDA and other Health Authorities that will lead to labels that will ensure clear communication of product attributes and potential risks, and which will align with the key messages defined for the product.
This position interfaces with many functions within the company, including CMC, Clinical, Safety, Medical Affairs, Marketing, and Quality. For products which are being developed and/or marketed as part of partnership agreements, they will collaborate with their counterparts to ensure alignment between the parties in their areas of responsibility. This position may be virtual, with travel expected to our New Jersey and Texas offices.
Key Responsibilities include but will not be limited to:
Advertising Promotion and Medical Affairs Review
* Overseeing/Implementing regulatory strategies and solutions to assure all advertising, promotional and Medical Affairs materials are in compliance with legal and regulatory requirements, industry guiding principles and company policies.
* Directing/providing regulatory review of advertising and promotional materials, key medical affairs materials, new campaigns and launch strategies for assigned products. Assuring accurate review of advertising and promotional material to meet internal timelines and requirements.
Prescription Drug Labeling
* Overseeing product labeling development and maintenance for all products throughout their lifecycles.
* Preparing and maintaining Target Product Profiles, Company Core Data Sheets, US Prescribing Information, Summaries of Product Characteristics, and Investigator Brochures
* Working closely with other Regulatory Affairs team members to implement product labeling changes and to assess and determine the impact of proposed labeling changes on product promotional materials.
* Serving as the company expert on prescription drug labeling: content, organization, presentation, structured data and electronic formats.
* Bachelor's degree in a scientific or medical discipline is required. Advanced degree (Ph.D, Pharm.D.) is preferred
* RAC certification is a plus
* Minimum of 15 years' experience in a regulatory position, for drugs or biologics, within biotech, pharmaceutical, biopharma service provider / consulting or clinical research organizations, including at least 10 years' experience in Regulatory Affairs prescription product advertising and promotion review and labeling development and revision
* Desirable: has led the development and maintenance of labeling for at least 5 products (including investigational and marketed products) and has provided regulatory review of advertising and promotional materials for at least 5 prescription products, preferably in several therapeutic areas.
* Also Required:
* Exhibits solid understanding of regulations, and guidance of regulatory authorities, political and legal climate and industry practices related to advertising and promotions to assist in meeting organizational goals
* Possesses and leverages broad industry knowledge, in particular in the areas of advertising, promotion and labeling
* Grasps regulatory implications of product strategy with regards to the product label, and advertising and promotional materials, and effectively communicates these to others
* Demonstrated ability to interpret and apply regulatory guidance relevant to labeling, advertising and promotional materials and associated supportive documentation, both in the pre-approval and post approval (maintenance) stages
* Demonstrated knowledge and understanding of Company Core Data Sheets, Core Safety Information, Investigator Brochures and related documents
* Ability to develop and implement complex processes and projects; ability to prepare and deliver strategic presentations for senior management
* Experience with labeling-related negotiations with Health Authorities
* Experience with direct FDA interaction (or other regulatory agencies)
To apply, please visit the careers section of our website: lexpharmacareers.silkroad.com/.
For additional information about Lexicon and its programs, please visit www.lexpharma.com.
An Equal Opportunity Employer: race, gender, disability and veteran status