Syndax Pharmaceuticals, founded in 2005, is a commercial-stage oncology innovator committed to advancing the next generation of targeted treatments to improve the lives of cance
Director, Commercial Regulatory Affairs, Labeling, Advertising, and Promotion
Location
United States
Posted
36 days ago
Salary
$225K - $250K / year
Seniority
Lead
No structured requirement data.
Job Description
Director, Commercial Regulatory Affairs, Labeling, Advertising, and Promotion
Syndax Pharmaceuticals
Role Description We are currently seeking a qualified, highly motivated, experienced individual for the position of Director, Commercial Regulatory Affairs, Labeling, Advertising, and Promotion to lead labeling activities and the review of promotional materials in commercial regulatory affairs at Syndax for the company’s 2 marketed FDA approved products in acute leukemia and chronic GVHD. The position reports to the Executive Director, Commercial Regulatory Affairs. The Director will: - Lead and provide strategic input and oversight of regulatory labeling activities. - Lead the Labeling Working Group (LWG) meeting to develop an optimal Target Product Label (TPL), U.S. Product Information (USPI) strategy, and EU SmPC when applicable. - Represent RA Labeling as the functional representative across the organizational levels relevant to assigned products and/or other activities. - Manage, oversee, review, and approve the work of more junior staff related to labeling activities. - Serve as a central point of contact and expert for global Regulatory teams in interpreting content and messaging of Company Core Data Sheets (CCDSs) and USPIs. - Act as a key advisor to cross-functional partners, stakeholders, and teams. - Assist with cross-functional meetings involved in the governance and decision-making of regulatory labeling with senior leadership. - Train cross-functional partners and teams on labeling processes, policies, procedures, standards, etc. - Engage business partners for planning and implementation on issues pertaining to product promotion. - Participate in the review and approval of promotional materials under the guidance of the Executive Director, Commercial Regulatory as assigned. - Provide the regulatory aspects for the review and approval process for product promotion materials. - Interact with commercial, medical, and legal on a regular basis. - Influence decision-making processes within the Promotional Review Committee (PRC). Qualifications - BS or BA degree required in life sciences in a relevant discipline. - Advance degree MA/MS, PharmD, or PhD preferred. - At least 8-10 years in pharmaceutical or biotech industry. - 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. - Direct experience leading a recent product launch in oncology preferred. - Experience with FDA standards for advertising and promotion compliance. - 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 manage multiple competing tasks and demands. Requirements - Regularly required to operate standard office equipment. - 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. - Occasional travel required. Benefits - Total compensation and rewards package that is among the most competitive in the industry. - Base pay determined within a range based on several factors including market data, experience, qualifications, and internal equity. - Overall package includes an equity offering, annual target bonuses, and an outstanding benefits program. - Anticipated annualized salary range for this role is $225,000 - $250,000.
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