Senior Director, Regulatory Affairs Advertising and Promotion Job at Xeris Pharm

Overview:

The Senior Director, Regulatory Affairs Advertising and Promotion is responsible for the overall strategy and oversight of the Regulatory Affairs Advertising and Promotion functions as well as post approval marketing activities. This individual will provide leadership and work closely with other areas within regulatory affairs as well as cross-functional teams. This position is responsible for providing strategic guidance on the development and implementation of advertising and promotional materials for pre-launch and commercial programs. Ensures compliance with applicable regulations, guidelines, corporate polices, and business objectives. 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 FDAs 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:

Masters 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

Working Conditions

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 managements discretion.

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As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.