[ref. d55953701] Senior Director, Regulatory Affairs Advertising and Promotion

Overview:

Facilitates effective communication and constructive working relationships with regulatory authorities (OPDP) and internal/external collaborators.

Responsibilities:

• Provide Leadership and oversight of the Advertising and Promotion Regulatory Affairs department.
• Determine overall regulatory strategy regarding promotion and labeling.
• Provide commercial regulatory knowledge, guidance, and risk assessments to cross-functional teams and senior management.
• Collaborate with cross-functional teams in creating and reviewing promotional materials to ensure compliance with related corporate and regulatory requirements while meeting strategic promotional objectives.
• Serve as the primary contact to the US FDA Office of Prescription Drug Promotion (OPDP).
• Lead negotiations with FDA’s OPDP division and ensure timely submission of promotional materials to OPDP.
• Ensure that changes in product labeling are appropriately implemented and reflected in current promotions and advertising.
• Participates in creation and revision of Regulatory Labeling activities including USPI, SMPC, and Core Data Sheet.
• Provide training on advertising, promotion, and labeling regulations to key stakeholders.
• Remain current on FDA regulations and guidance associated with advertising, promotion, labeling, and regulatory applications.
• Provide direct supervision of individuals including mentoring, performance management and staffing decisions.
• Liaise with other functional areas as necessary to achieve success for strategic and tactical initiatives.
• Provide expertise and review to compliance and diligence processes.

Qualifications:

• Master’s level degree required, PhD, PharmD or other doctoral level degree highly desired.
• At least 15 years of pharmaceutical industry with extensive experience (8+ years) in the US Regulatory Affairs Advertising and Promotion and/or Labeling specialties.
• Proven regulatory leadership experience in a cross-functional role with significant product development experience.
• Thorough understanding of regulatory requirements for compliant advertising and promotional materials.
• History of providing creative solutions to Commercial teams exhibiting superior judgment and a balanced, realistic understanding of issues.
• Strong technical knowledge of drug labeling contents and regulatory requirements, as well as experience creating and maintaining CCDS.
• Strong knowledge and interest in the evolving landscape of promotion and labeling regulations.
• Established understanding of product registration processes and their interdependence with product and promotional labeling.
• Competencies: Strategic Leadership, Transformational Leadership, Teamwork & Collaboration, Organization skills, Attention to Detail, Problem Solving, Written and Verbal Communications, Presentation skills

• Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel.
• This is a hybrid role based in Xeris’ Chicago office and requires a minimum of three days per week in the office. On-site requirement may change at management’s discretion.

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It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.