Regulatory Advertising and Promotion Lead

Location: Zug or remote (Europe)

Reporting: Senior Director, International Regulatory Affairs

Description

• The Associate Director of International Advertising and Promotion (A&P) serves as an internal expert on industry codes and guidance and regulations governing the promotion of medicinal products and disease awareness activities. This individual will provide regulatory oversight on promotional review committees (PRC) and medical review committees (MRC) to help ensure regulatory compliance of promotional and non-promotional materials generated for Apellis products and/or investigational compounds in the international regions.
• The Associate Director of International Advertising and Promotion will be tasked with the development, maintenance and implementation of internal SOPs and work instructions for the review and approval of materials in the Veeva system that will be used in the international region. The role serves as the process expert and is the lead for applicable A&P projects to ensure collaboration with key stakeholders and completion as planned.
• Works collaboratively with colleagues in Regulatory Affairs, Medical, Legal, Commercial and Ethics & Compliance organizations and applies expertise to ensure that the development of promotional and disease state materials is accomplished through compliance with internal processes and standards.
• This role will also oversee service providers, contractors and potential future employees in the International Advertising and Promotion group.

Specific Roles And Responsibilities

• Evaluates materials to ensure compliance with international regulations, industry codes, guidance, corporate standards and policies and business objectives. In collaboration with Commercial, Medical and Legal colleagues, conducts a detailed review and evaluation of the adequacy of clinical evidence provided to support proposed claims that are consistent with product labeling. Provides consistent, well-supported, and clear guidance to key stakeholders.
• Serves as the regulatory representative of PRC/MRC meetings and assists commercial/medical with the planning and prioritization of proposed promotional and disease state materials.
• Provides expert guidance related to Regulatory strategy to key stakeholders during early development of projects to ensure promotional goals can be achieved (e.g., target product profile; clinical trial recruitment materials).
• Develops, maintains and implements internal SOPs and work instructions, fit for Apellis, for the review and approval of materials in the Veeva system that will be used in the international region
• Provides recommendations for process improvements to address issues, gains agreement of process improvements from key stakeholders, and helps implement agreed-upon process improvements.
• Understands broad concepts within regulatory affairs and potential implications across organization. Proactively identifies regulatory issues. Offers creative solutions and strategies, including risk mitigation strategies.
• Leads international advertising and promotion project workstreams (e.g., guidance documents) and active participant at global regulatory affairs team staff meetings
• Manages the relationship with local A&P service providers throughout the International region, including contracting, oversight, workload management, budget and invoicing. These service providers will be charged with regulatory reviews as well as submission for regulatory authorities’ approval, where required.
• Supports the development, integration and update of the local processes and standards for promotional & non-promotional review and ensure full training implementation for countries within the international region.
• Collaborates with the Global and US advertising and promotion reviewer to provide input on materials that are intended for global audiences (e.g., global press releases, new global campaigns).
• Manages future employees/contractors in the international A&P group

Qualifications And Requirements

• Doctorate, Master’s, or Bachelor’s degree in a relevant/scientific discipline (graduate degree preferred)
• Minimum of 5 years’ experience in International review and approval process of pharmaceutical/biologics promotion
• Previous experience guiding commercial teams through the approval & launch process (either NME approval or new indication approval)
• Mastery of International (ex-US) regulations and codes on advertising and promotion for prescription products
• Solid understanding of pharmaceutical promotion development and review process
• Strong interpersonal skills with ability to demonstrate strategic and analytic thinking
• Demonstrated ability to communicate clearly and concisely.
• Effective written and verbal communication skills in order to manage, motivate and drive decisions within teams.
• Proven skills in negotiation, influencing without authority and working diplomatically through conflict.
• Ability to work independently, take initiative and complete tasks to deadlines

Travel Requirements

• International travel may be required, and is expected if the candidate is not located in Switzerland
• Ability to attend offsite meetings that may involve overnight stay