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

Syndax Pharmaceuticals is looking for a Director, Commercial Regulatory Affairs, Labeling, Advertising, and Promotion

 

At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals is a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies.

 

The Role: 

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 including labeling strategy for future indications of the lead company asset. The Director will lead the Labeling Working Group (LWG) meeting to develop an optimal Target Product Label (TPL), and U.S. Product Information (USPI) strategy and EU SmPC when applicable. This role will represent RA Labeling as the functional representative across the organizational levels relevant to assigned products and/or other activities. This role may include future responsibilities for managing, overseeing, reviewing, and approving the work of more junior staff related to labeling activities.  This role will help to serve regulatory strategy in managing complex labeling negotiations with regulatory health authorities for future label expansion. This role also serves the 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.  The Director will act as a key advisor to cross-functional partners, stakeholders, and teams and lead impact assessments on major labeling issues. This role will assist with cross-functional meetings involved in the governance and decision-making of regulatory labeling with senior leadership in Labe Committee (LC) and when applicable strategic Task Forces for critical labeling workstreams. This role will be responsible for training cross-functional partners and teams on labeling processes, policies, procedures, standards, etc.

The Director will engage business partners for planning and implementation on issues pertaining to product promotion and will participate in the review and approval of promotional materials under the guidance of the Executive Director, Commercial Regulatory as assigned.  This role will include regulatory review of promotional materials for 2 marketed products with opportunities to further refine regulatory review skills in complex areas. 

He or she will provide the regulatory aspects for the review and approval process for product promotion materials working collaboratively with respective legal, medical and commercial colleagues.  This role involves interacting with commercial, medical and legal on a regular basis.  The candidate will have direct influence on the decision-making processes within the Promotional Review Committee (PRC) within the scope of the advertising and promotion of assigned marketed products and commercial compliance for Syndax.

 

Key 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

 

 Desired Experience/Education and Personal Attributes: 

• 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 with at least 6 years in regulatory affairs labeling, advertising and promotion, which may include relevant PharmD post-doctoral fellowship experience, and recent launch experience preferred
• 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
• 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
• Occasional travel required 

 

Location: Syndax’s corporate office is in New York, NY.

Syndax offers a total compensation and rewards package that is among the most competitive in the industry. Base pay is just one element of our package and is determined within a range based on several factors including market data, experience, qualifications, demonstrated skills, relevant education or training, travel requirements and internal equity. Our overall package also includes an equity offering, annual target bonuses, and an outstanding benefits program. The anticipated annualized salary range for this role is $225,000 - $250,000.

 

About Syndax:
Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company advancing innovative cancer therapies. Highlights of the Company’s pipeline include a menin inhibitor for R/R acute leukemia and a monoclonal antibody that blocks the CSF-1 receptor for chronic graft-versus-host disease. Fueled by our commitment to reimagining cancer care, Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment. For more information, please visit www.syndax.com/ or follow the Company on X and LinkedIn.

 Syndax Pharmaceuticals is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

 

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