Director, Commercial Regulatory Affairs, Labeling, Advertising, and Promotion

Syndax Pharmaceuticals • New York, NY

7h • Remote

About The Position

Syndax Pharmaceuticals is a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies. The company is looking for a Director, Commercial Regulatory Affairs, Labeling, Advertising, and Promotion to lead labeling activities and the review of promotional materials for its two marketed FDA approved products in acute leukemia and chronic GVHD. This role involves providing strategic input and oversight of regulatory labeling activities, including labeling strategy for future indications, leading the Labeling Working Group (LWG) to develop optimal Target Product Label (TPL), U.S. Product Information (USPI) strategy, and EU SmPC when applicable. The Director will represent RA Labeling across organizational levels, manage junior staff related to labeling, and assist in complex labeling negotiations with regulatory health authorities. The role also serves as a central point of contact for global Regulatory teams in interpreting content of Company Core Data Sheets (CCDSs) and USPIs, acting as a key advisor to cross-functional partners, and leading impact assessments on major labeling issues. Additionally, the Director will engage business partners for planning and implementation on product promotion issues, participate in the review and approval of promotional materials for two marketed products, and provide regulatory aspects for the Promotional Review Committee (PRC) process, working collaboratively with legal, medical, and commercial colleagues.

Requirements

• BS or BA degree required in life sciences in a relevant discipline
• At least 8-10 years in pharmaceutical or biotech industry with at least 6 years in regulatory affairs labeling, advertising and promotion
• Proficiency in Veeva, Microsoft Word, Excel, PowerPoint, and Adobe Acrobat
• Solid knowledge of U.S. FDA labeling requirements
• Experience with FDA standards for advertising and promotion compliance
• Proven track record practicing sound judgment and PRC advice as it relates to risk
• Strong listening, verbal, and written communication and presentation skills
• Knowledgeable on industry compliance requirements and enforcement trends
• Strong interpersonal communication and leadership skills
• Proven ability to prioritize and to manage multiple competing tasks and demands and meet critical business timelines
• Regularly required to operate standard office equipment (personal computer, photocopy machine, fax, etc.)
• Ability to work on a computer for extended periods of time
• Regularly required to sit for long periods of time, and occasionally stand and walk
• Regularly required to use hands to operate computer and other office equipment
• Close vision required for computer usage
• Occasionally required to stoop, kneel, climb and lift up to 20 pounds

Nice To Haves

• Advance degree MA/MS, PharmD, or PhD preferred
• Relevant PharmD post-doctoral fellowship experience
• Recent launch experience preferred
• Direct experience leading a recent product launch in oncology preferred

Responsibilities

• Develops and accountable for end-to-end labeling processes, activities, and respective SOPs for lifecycle development of CCDS, USPI
• Independently authors new/revised TPL, TPP, CCDS, USPI and when applicable EU SmPC for assigned products, obtaining input and approval from all relevant functional areas with appropriate annotations and supporting documentation
• Leads Labeling cross-functional working group (LWG) and interacts with cross-functional senior leadership to resolve complex issues, including leading and contributing to cross-functional initiatives by providing expertise in labeling best practices
• Facilitates the process to obtain labeling approval by Label Committee (LC) with senior leadership to ensure alignment of the labeling strategy and labeling content at all levels
• Independently authors/manages outgoing communications regarding significant labeling changes and CCDS changes for assigned products
• Establishes collaborative relationships among functions represented at the LWG, including clinical, safety, medical affairs, and commercial, to ensure effective communication for labeling strategy and content
• Conducts precedent searches, analyzes relevant analogs or competitor labeling, labeling guidance and trends; and develops labeling language for inclusion to assigned product labels (TLP, CCDS, USPI, when applicable EU SmPC,) to ensure consistency with the overall product strategy, product claims and information in the CCDS
• Functional representative during internal and external audits and HA inspections
• Contribute to the global labeling strategy, including demonstrating an understanding of competitors in the therapeutic area and their development plans and status and knowledge of labeling aspects for the development of labeling and target labeling
• Leads reviews of US promotional materials for axatilimab and represents the commercial regulatory function on the commercial sub team
• Cross trains and reviews US promotional materials for revumenib patient materials, and sales training materials. Will further refine regulatory review skills with manager on HCP materials, HCP disease awareness communications, field medical materials by attending the Promotional Review Committee (PRC)
• Thoroughly review and assess proposed promotional items to evaluate their completeness, accuracy, and compliance with regulatory requirements, Syndax policies, and FDA regulations pertaining to prescription drug advertising and promotion
• Ensures stakeholder awareness of proposed and newly approved labeling changes and FDA guidance documents
• Provide guidance to PRC on appropriate implementation of label changes into promotion and updating and managing versions of the HCP and Consumer ISI for promotional materials in a timely manner
• Ensure timely submission of all applicable approved promotional materials to the FDA on Form 2253s
• Participate in professional associations and training meetings related to labeling, advertising and promotion regulatory requirements and relevant medical congresses within assigned therapeutic areas
• Other duties as assigned

Benefits

• Total compensation and rewards package that is among the most competitive in the industry
• Equity offering
• Annual target bonuses
• Outstanding benefits program

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 101-250 employees