Associate Director, Commercial Regulatory Affairs, Labeling Lead

Syndax Pharmaceuticals is looking for an Associate Director, Commercial Regulatory Affairs, Labeling Lead

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 clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies.

The Role:

The Associate Director will provide strategic advice as well as subject matter expertise to cross-functional teams on matters related to labeling.  This role will lead labeling activities while also having the opportunity to develop skills in the review of advertising and promotion materials for pharmaceutical products. The Associate Director will serve as the Regulatory Affairs (RA) representative on assigned labeling and product promotion review teams. The Associate Director has responsibility for the development and implementation of labeling content in various stages of drug development, which may include one product with multiple indications resulting in updates to or creation of a new TPP, CCDS, USPI and EU SmPC. 

The Associate Director will engage business partners for strategic planning 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.

He or she will provide the regulatory aspects for the review and approval process for product promotion materials working collaboratively with senior 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 marketed products and commercial compliance for Syndax.

Key Responsibilities:

• Lead the development, revision, review, agreement, and maintenance of primary labeling (the Company Core Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, EU Product Information (SmPC).
• Make recommendations and provide advice and guidance about labeling content, processes, timelines, and scientific integrity. Coordinate the resolution of any labeling issues with potential impact on the primary or derived labeling, or the supporting documentation.
• Ensure high-quality and compliant labeling documents. This role may collaborate with external partners.
• 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.
• Contribute to the continuous improvement of the end-to-end labeling process.
• Reviews US promotional materials, disease awareness communications, field medical materials, sales training materials, and corporate communications by attending the Promotional Review Committee (PRC). Provide regulatory guidance to the cross-functional team responsible for ensuring material compliance with Syndax policies and FDA regulations pertaining to prescription drug advertising and promotion, as applicable.
• Thoroughly review and assess proposed promotional items to evaluate their completeness, accuracy, and compliance with regulatory requirements and Syndax policies.
• In collaboration with their manager, will provide advice to product development teams on advertising and promotion issues to facilitate the strategic development of new products within the Syndax pipeline.
• Ensures stakeholder awareness of proposed and newly approved labeling changes and FDA guidance documents.
• Provide guidance to PRC to ensure appropriate implementation for assigned product, including 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 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 6 years in pharmaceutical or biotech industry with at least 4 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.

Location: Syndax has offices in Waltham, MA and New York City and has a dispersed workforce across the United States.

About Syndax:
Syndax Pharmaceuticals is a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies. Highlights of the Company's pipeline include revumenib a highly selective menin inhibitor, and Niktimvo™ (axatilimab-csfr), a monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor. Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment for both revumenib and Niktimvo. For more information, please visit www.syndax.com/ or follow the Company on X (formerly Twitter) and LinkedIn.

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